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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03099187
Registration number
NCT03099187
Ethics application status
Date submitted
31/03/2017
Date registered
4/04/2017
Titles & IDs
Public title
A Study of Pirfenidone in Patients With Unclassifiable Progressive Fibrosing Interstitial Lung Disease
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Scientific title
Multicenter, International, Double-blind, Two-Arm, Randomized, Placebo-controlled Phase II Trial of Pirfenidone in Patients With Unclassifiable Progressive Fibrosing ILD
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Secondary ID [1]
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2016-002744-17
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Secondary ID [2]
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MA39189
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Lung Diseases, Interstitial
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Condition category
Condition code
Respiratory
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Pirfenidone
Treatment: Drugs - Placebo
Experimental: Pirfenidone - Participants will receive pirfenidone 267 mg capsule three times a day from Day 1 to 7 followed by 2 capsules three times a day from Day 8 to 14 then 3 capsules three times a day from Day 15 up to Week 24.
Experimental: Placebo - Participants will receive matching placebo capsule three times a day from Day 1 to 7 followed by 2 capsules three times a day from Day 8 to 14 then 3 capsules three times a day from Day 15 up to Week 24.
Treatment: Drugs: Pirfenidone
Pirfenidone 267 mg capsules three times in a day.
Treatment: Drugs: Placebo
Matching placebo capsules three times in a day.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Rate of Decline in Forced Vital Capacity (FVC) Over the 24-week Double-blind Treatment Period
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Assessment method [1]
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Rate of decline in FVC was measured in mL by daily handheld spirometer. The analyses were repeated due to an additional independent review of the home spirometry data.
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Timepoint [1]
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Up to Week 24
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Secondary outcome [1]
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Change in Percent Predicted FVC
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Assessment method [1]
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FVC was measured in liter (L) by spirometry. The analyses were repeated due to additional data cleaning activities that were not conducted during the primary analysis.
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Timepoint [1]
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Baseline (Day 1) to Week 24
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Secondary outcome [2]
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Change in FVC
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Assessment method [2]
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FVC was measured in liter (L) by spirometry. The analyses were repeated due to additional data cleaning activities that were not conducted during the primary analysis.
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Timepoint [2]
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Baseline (Day 1) to Week 24
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Secondary outcome [3]
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Categorical Change in FVC of >5%
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Assessment method [3]
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Categorical change in FVC was measured both by daily spirometry as well as by spirometry during clinical visits. Only the site spirometry data were used as the daily spirometry data were not normally distributed. The analyses were repeated due to additional data cleaning activities that were not conducted during the primary analysis.
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Timepoint [3]
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Baseline (Day 1) to Week 24
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Secondary outcome [4]
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Categorical Change in FVC of >10%
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Assessment method [4]
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Categorical change in FVC was measured both by daily spirometry as well as by spirometry during clinical visits. Only the site spirometry data were used as the daily spirometry data were not normally distributed. The analyses were repeated due to additional data cleaning activities that were not conducted during the primary analysis.
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Timepoint [4]
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Baseline (Day 1) to Week 24
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Secondary outcome [5]
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Change in Percent Predicted Diffusing Capacity of the Lung for Carbon Monoxide (DLco)
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Assessment method [5]
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The DLco is a pulmonary function test that measures the capacity for the lung to carry out gas exchange between the inhaled breath and the pulmonary capillary blood vessels and the DLco %-predicted represents the DLco expressed as a percentage of the expected normal valued based on the participant's age, height, gender and ethnicity.
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Timepoint [5]
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Baseline (Day 1) to Week 24
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Secondary outcome [6]
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Change in 6-minute Walk Distance (6MWD)
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Assessment method [6]
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Comparison of 6-minute walk distance before beginning and after completing study therapy.
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Timepoint [6]
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Baseline (Day 1) to Week 24
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Secondary outcome [7]
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Change in University of California, San Diego-Shortness of Breath Questionnaire Score
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Assessment method [7]
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University of California, San Diego Shortness of Breath Questionnaire (SOBQ) consists of 24-item on a scale of 0 to 5 with 0=not at all and 5=maximal or unable to do because of breathlessness. The total scores were calculated by summation of the 24 items scores and transformed into 0-100, with 0= poor quality of life , and 100= excellent quality of life.
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Timepoint [7]
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Baseline (Day 1) to Week 24
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Secondary outcome [8]
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Change in Score in Leicester Cough Questionnaire Score
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Assessment method [8]
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The Leicester Cough Questionnaire is a patient-reported questionnaire evaluating the impact of cough on quality of life. The questionnaire comprises 19 items. Each item assesses symptoms, or the impact of symptoms, over the last 2 weeks on a seven-point Likert scale. Scores in three domains (physical, psychological and social) were calculated as a mean for each domain (range 1 to 7). A total score (range 3 to 21) was also calculated by adding the domain scores together. Higher scores indicate better quality of life.
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Timepoint [8]
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Baseline (Day 1) to Week 24
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Secondary outcome [9]
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Change in Cough Visual Analog Scale (VAS) Score
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Assessment method [9]
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Cough VAS are 100-mm linear scales on which participants indicate the severity of their cough; 0 mm represents no cough and 100 mm the worst cough ever.
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Timepoint [9]
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Baseline (Day 1) to Week 24
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Secondary outcome [10]
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Change in Total and Sub-scores of the Saint George's Respiratory Questionnaire (SGRQ)
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Assessment method [10]
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The SGRQ is a 50-item questionnaire developed to measure health status (quality of life) in participants with diseases of airways obstruction. Three component scores are: Symptoms (respiratory symptoms and severity); Activity (activities that cause or are limited by breathlessness); Impacts (social functioning and psychological disturbances due to airway disease). Each component sub-scores are calculated from the summed weights for the positive responses to questions. Total score summaries the impact of disease on overall health status. Scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status. It is calculated by summing all positive responses in the questionnaire and expressing the result as a percentage of the total weight for the questionnaire.
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Timepoint [10]
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Baseline (Day 1) to Week 24
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Secondary outcome [11]
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Number of Participants With Non-elective Hospitalization, Both Respiratory and All Cause
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Assessment method [11]
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Participants with non-elective hospitalization are reported.
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Timepoint [11]
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Baseline (Day 1) to Week 24
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Secondary outcome [12]
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Percentage of Participants With Investigator-reported Acute Exacerbations
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Assessment method [12]
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Percentage of participants with acute exacerbation arereported.
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Timepoint [12]
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Baseline (Day 1) to Week 24
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Secondary outcome [13]
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Time to First Investigator-reported Acute Exacerbations
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Assessment method [13]
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Time to first investigator reported acute exacerbations from start of treatment are reported.
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Timepoint [13]
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Baseline (Day 1) to Week 24
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Secondary outcome [14]
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Progression-free Survival (PFS)
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Assessment method [14]
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PFS is defined as the time to the first occurrence of a \>10% absolute decline in percent predicted FVC, a \>50 m decline of 6MWD, or death.
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Timepoint [14]
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Baseline (Day 1) to Week 24
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Secondary outcome [15]
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Progression-free Survival (PFS)
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Assessment method [15]
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PFS is defined as the time to the first occurrence of a \>10% relative decline in percent predicted FVC, non-elective respiratory hospitalization, or death.
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Timepoint [15]
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Baseline (Day 1) to Week 24
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Secondary outcome [16]
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Time to Death From Any Cause
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Assessment method [16]
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Time to first documented death from start of treatment is reported.
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Timepoint [16]
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Baseline (Day 1) to Week 24
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Secondary outcome [17]
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Time to Death From Respiratory Diseases
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Assessment method [17]
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Time to first documented death due to respiratory diseases from start of treatment will be reported.
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Timepoint [17]
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Baseline (Day 1) to Week 24
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Secondary outcome [18]
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Number of Participants With Treatment-emergent Adverse Events (TEAEs)
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Assessment method [18]
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An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
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Timepoint [18]
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Baseline (Day 1) to Week 28
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Secondary outcome [19]
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Number of Participants With Dose Reductions and Treatment Interruptions During the Double-Blind Period
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Assessment method [19]
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Number of participants with dose reduction and treatment interruptions are reported.
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Timepoint [19]
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From administration of the first dose of study drug to Week 24
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Secondary outcome [20]
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Number of Participants With Dose Reductions and Treatment Interruptions During the 12-month Safety Follow-up
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Assessment method [20]
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Number of participants with dose reduction and treatment interruptions are reported.
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Timepoint [20]
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From the Follow-up Visit at Week 28 through the follow-up period of 12 Months
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Secondary outcome [21]
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Number of Participants Withdrawn From Trial Treatment or Trial Discontinuations During the Double-Blind Period
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Assessment method [21]
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Number of participants withdrawn from trial treatment or trial discontinuations are reported.
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Timepoint [21]
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Baseline (Day 1) to Week 24
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Secondary outcome [22]
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Number of Participants Withdrawn From Trial Treatment or Trial Discontinuations During the 12-month Safety Follow-up
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Assessment method [22]
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Number of participants withdrawn from trial treatment or trial discontinuations are reported.
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Timepoint [22]
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From the Follow-up Visit at Week 28 through the follow-up period of 12 Months
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Eligibility
Key inclusion criteria
* Age >= 18-85 years
* Confirmed fibrosing ILD which, following multidisciplinary team review, cannot be classified with either high or moderate confidence as a specific idiopathic interstitial pneumonia or other defined ILD
* Progressive disease as considered by the investigator as participants deterioration within the last 6 months, which is defined as a rate of decline in forced vital capacity (FVC) >5% or a significant symptomatic worsening not due to cardiac, pulmonary vascular or other causes
* Extent of fibrosis >10% on high-resolution computed tomography
* Forced vital capacity >= 45% of predicted value
* Diffusing capacity of the lung for carbon monoxide (DLco) >= 30% of predicted value
* Forced expiratory volume in 1 second/FVC ratio >= 0.7
* Able to do 6-minute walk distance (6MWD) >= 150 meters
* For women of childbearing potential: agreement to remain abstinent or use a non-hormonal or hormonal contraceptive method with a failure rate of < 1% per year during the treatment period and for at least 90 days after the last dose of pirfenidone
* For men, agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm
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Minimum age
18
Years
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Maximum age
85
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Diagnosis with moderate or high confidence of nonspecific interstitial pneumonia and any ILD with an identifiable cause such as connective tissue disease-ILD, chronic hypersensitivity pneumonitis, or others
* Diagnosis of idiopathic pulmonary fibrosis independent of the confidence level
* History of unstable angina or myocardial infarction during the previous 6 months
* Treatment with high dose systemic corticosteroids, or any immunosuppressant other than mycophenolate mofetil/acid (MMF), at any time within the 4 weeks of the screening period. Participants being treated with MMF should be on a stable dose that is expected to remain stable throughout the trial and was started at least 3 months prior to screening
* Participants previously treated with pirfenidone or nintedanib
* Participants treated with N-acetyl-cysteine for fibrotic lung disease, at any time within the 4 weeks of the screening period
* Drug treatment for any type of pulmonary hypertension
* Participation in a trial of an investigational medicinal product within the last 4 weeks
* Significant other organ co-morbidity including hepatic or renal impairment
* Predicted life expectancy < 12 months or on an active transplant waiting list
* Use of any tobacco product in the 12 weeks prior to the start of screening, or any unwillingness to abstain from their use through to the Follow-up Visit
* Illicit drug or alcohol abuse within 12 months prior to screening
* Planned major surgery during the trial
* Hypersensitivity to the active substance or to any of the excipients of pirfenidone
* History of angioedema
* Concomitant use of fluvoxamine
* Clinical evidence of any active infection
* Any history of hepatic impairment, elevation of transaminase enzymes, or liver function test results as: Total bilirubin above the upper limit of normal (ULN), Aspartate aminotransferase or alanine aminotransferase >1.5 × ULN, and Alkaline phosphatase >2.0 × ULN
* Creatinine clearance < 30 milliliter (mL) per minute, calculated using the Cockcroft-Gault formula
* Any serious medical condition, clinically significant abnormality on an Electrocardiogram (ECG) at screening, or laboratory test results
* An ECG with a heart rate corrected QT interval using Fridericia's formula as >= 500 milliseconds at screening, or a family or personal history of long QT syndrome
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
15/05/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
10/01/2020
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Sample size
Target
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Accrual to date
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Final
253
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [2]
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John Hunter Hospital; Respiratory Department; Respiratory Department - New Lambton Heights
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Recruitment hospital [3]
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Lung Research Queensland - Nundah
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Recruitment hospital [4]
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Princess Alexandra Hospital, Department of Respiratory and Sleep Medicine - Woolloongabba
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Recruitment hospital [5]
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Royal Adelaide Hospital; Respiratory Clinical Trials Unit, Thoracic Medicine - Adelaide
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Recruitment hospital [6]
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Respiratory Department - Heidelberg
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Recruitment hospital [7]
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The Alfred Hospital - Prahan
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Recruitment hospital [8]
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Fiona Stanley Hospital; Advanced Lung Disease Unit - Murdoch
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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2305 - New Lambton Heights
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Recruitment postcode(s) [3]
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4101 - Nundah
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Recruitment postcode(s) [4]
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4102 - Woolloongabba
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Recruitment postcode(s) [5]
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5000 - Adelaide
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Recruitment postcode(s) [6]
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3084 - Heidelberg
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Recruitment postcode(s) [7]
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3181 - Prahan
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Recruitment postcode(s) [8]
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6150 - Murdoch
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Recruitment outside Australia
Country [1]
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Belgium
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State/province [1]
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Brussels
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Country [2]
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Belgium
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State/province [2]
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Bruxelles
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Belgium
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State/province [3]
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Leuven
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Canada
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State/province [4]
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British Columbia
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Country [5]
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Canada
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State/province [5]
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Ontario
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Country [6]
0
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Czechia
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State/province [6]
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Brno
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Country [7]
0
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Czechia
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State/province [7]
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Jihlava
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Country [8]
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Czechia
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State/province [8]
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Olomouc
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Country [9]
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Czechia
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State/province [9]
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Praha 2
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Country [10]
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Denmark
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State/province [10]
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Aarhus N
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Country [11]
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Denmark
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State/province [11]
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Hellerup
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Country [12]
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Denmark
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State/province [12]
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Odense C
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Country [13]
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Germany
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State/province [13]
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Bad Berka
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Germany
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State/province [14]
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Berlin
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Germany
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Gießen
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Germany
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State/province [16]
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Heidelberg
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Country [17]
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Germany
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State/province [17]
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München
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Country [18]
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Greece
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State/province [18]
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Athens
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Country [19]
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Greece
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State/province [19]
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Chaidari
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Greece
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State/province [20]
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Heraklio
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Ireland
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Dublin
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Israel
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Beer Sheba
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Israel
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Haifa
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Israel
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State/province [24]
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Jerusalem
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Israel
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State/province [25]
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Kfar Saba
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Israel
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State/province [26]
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Petach Tikva
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Israel
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State/province [27]
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Rehovot
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Italy
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State/province [28]
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Emilia-Romagna
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Italy
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State/province [29]
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Lombardia
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Italy
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State/province [30]
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Marche
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Italy
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State/province [31]
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Piemonte
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Italy
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Toscana
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Poland
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Gdansk
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Poland
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Lodz
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Poland
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Warszawa
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Portugal
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Aveiro
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Portugal
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Coimbra
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Portugal
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Porto
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Portugal
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Vila Nova De Gaia
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Spain
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Barcelona
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Spain
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Cantabria
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Spain
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Madrid
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Country [43]
0
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United Kingdom
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State/province [43]
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Birmingham
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Country [44]
0
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United Kingdom
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State/province [44]
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Bristol
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0
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United Kingdom
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State/province [45]
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Cambridge
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Country [46]
0
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United Kingdom
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State/province [46]
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Edinburgh
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Country [47]
0
0
United Kingdom
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State/province [47]
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Exeter
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Country [48]
0
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United Kingdom
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State/province [48]
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Leicester
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Country [49]
0
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United Kingdom
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State/province [49]
0
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London
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Country [50]
0
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United Kingdom
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Manchester
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Country [51]
0
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United Kingdom
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Sheffield
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0
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United Kingdom
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State/province [52]
0
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Southampton
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Country [53]
0
0
United Kingdom
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State/province [53]
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Stoke on Trent
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Hoffmann-La Roche
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to evaluate the efficacy and safety of pirfenidone in participants with fibrosing interstitial lung disease (ILD) who cannot be classified with moderate or high confidence into any other category of fibrosing ILD by multidisciplinary team (MDT) review ("unclassifiable" ILD).
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Trial website
https://clinicaltrials.gov/study/NCT03099187
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Trial related presentations / publications
Molina-Molina M, Kreuter M, Cottin V, Corte TJ, Gilberg F, Kirchgaessler KU, Axmann J, Maher TM. Efficacy of Pirfenidone vs. Placebo in Unclassifiable Interstitial Lung Disease, by Surgical Lung Biopsy Status: Data From a post-hoc Analysis. Front Med (Lausanne). 2022 Jun 17;9:897102. doi: 10.3389/fmed.2022.897102. eCollection 2022. Kreuter M, Maher TM, Corte TJ, Molina-Molina M, Axmann J, Gilberg F, Kirchgaessler KU, Cottin V. Pirfenidone in Unclassifiable Interstitial Lung Disease: A Subgroup Analysis by Concomitant Mycophenolate Mofetil and/or Previous Corticosteroid Use. Adv Ther. 2022 Feb;39(2):1081-1095. doi: 10.1007/s12325-021-02009-w. Epub 2021 Dec 22. Maher TM, Corte TJ, Fischer A, Kreuter M, Lederer DJ, Molina-Molina M, Axmann J, Kirchgaessler KU, Samara K, Gilberg F, Cottin V. Pirfenidone in patients with unclassifiable progressive fibrosing interstitial lung disease: a double-blind, randomised, placebo-controlled, phase 2 trial. Lancet Respir Med. 2020 Feb;8(2):147-157. doi: 10.1016/S2213-2600(19)30341-8. Epub 2019 Sep 29. Graney BA, Fischer A. Interstitial Pneumonia with Autoimmune Features. Ann Am Thorac Soc. 2019 May;16(5):525-533. doi: 10.1513/AnnalsATS.201808-565CME. Maher TM, Corte TJ, Fischer A, Kreuter M, Lederer DJ, Molina-Molina M, Axmann J, Kirchgaessler KU, Cottin V. Pirfenidone in patients with unclassifiable progressive fibrosing interstitial lung disease: design of a double-blind, randomised, placebo-controlled phase II trial. BMJ Open Respir Res. 2018 Sep 4;5(1):e000289. doi: 10.1136/bmjresp-2018-000289. eCollection 2018.
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Contacts
Principal investigator
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Hoffmann-La Roche
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
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Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/87/NCT03099187/Prot_002.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/87/NCT03099187/SAP_003.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT03099187