Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00117182




Registration number
NCT00117182
Ethics application status
Date submitted
30/06/2005
Date registered
4/07/2005
Date last updated
20/04/2016

Titles & IDs
Public title
Aridol Challenge as a Tool to Predict Treatment Response to Inhaled Corticosteroids in COPD
Scientific title
A Phase II Study to Investigate Mannitol Challenge as a Tool to Predict Treatment Response to Inhaled Corticosteroids in COPD
Secondary ID [1] 0 0
DPM-COPD-201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Diseases, Obstructive 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Forced expiratory volume in one second (FEV1)
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Response dose ratio (RDR)
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Dose of provoking stimulus causing a 15%, 12% or 10% fall in FEV1 (PD15, PD12, PD10)
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Lung function values
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Quality of life assessed by St. George's Respiratory Questionnaire (SGRQ)- total score
Timepoint [4] 0 0
Secondary outcome [5] 0 0
COPD clinical control scores (CCQ)
Timepoint [5] 0 0
Secondary outcome [6] 0 0
Exacerbation frequency
Timepoint [6] 0 0
Secondary outcome [7] 0 0
Days on antibiotics
Timepoint [7] 0 0
Secondary outcome [8] 0 0
Days off work or days unable to carry out normal activities
Timepoint [8] 0 0
Secondary outcome [9] 0 0
Reversibility of airflow obstruction
Timepoint [9] 0 0

Eligibility
Key inclusion criteria
* Diagnosis of COPD (history, spirometry, symptoms including chronic cough and/or shortness of breath that is worse on exertion and/or excess sputum production)
* Aged 45 - 80 years
* Have pre-bronchodilator FEV1 > 1.4 litres and at least 60% of predicted for height, age and gender and a post-bronchodilator FEV1 <80% of predicted for height, age and gender
* Post-bronchodilator FEV1/FVC < 70 %
* = 10 pack years smoking history
* As determined by the investigator, are capable and willing to:

* perform all of the techniques necessary to measure lung function;
* administer the dry powder mannitol.
* Are capable of, and have given informed consent to, participating in this study in accordance with local regulations.
* The subject must be in stable clinical condition at the time of, and for a period of 14 days prior to, their recruitment into the study. Stable clinical condition is defined as lack of:

* change in sputum production (volume, colour, consistency);
* increased cough;
* worsening dyspnoea;
* increased malaise, fatigue or lethargy;
* reduction in exercise tolerance;
* fever;
* antibiotic treatment (for respiratory infection).
Minimum age
45 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Investigators, site personnel directly affiliated with this study, and their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biologically or legally adopted.
* Subjects receiving treatment with inhaled corticosteroids (including combination therapies, e.g. Seretide®, Symbicort®) or oral corticosteroids within the last 6 weeks.
* Subjects who have had an exacerbation or a chest infection within the 2 weeks prior to the study.
* Subjects receiving antibiotic treatment for respiratory infection.
* Known diagnosis of asthma or allergic rhinitis.
* Myocardial infarction in the six months prior to enrolment.
* Cerebral vascular accident in the six months prior to enrolment.
* Ocular surgery in the three months prior to enrolment.
* Abdominal surgery in the three months prior to enrolment.
* Active tuberculosis (TB).
* Lung cancer or any other malignancies, which are considered by the investigator as a contraindication to participating in the study.
* Lung disease other than COPD (e.g. bronchiectasis).
* Uncontrolled insulin-dependant or non-insulin dependant diabetes, i.e. >10% HbA1c.
* Female subjects of reproductive capability, not using a reliable form of contraception
* Inability to obtain informed consent from the subject or subject's authorised representative.
* Subjects who have participated in another investigative drug study parallel to, or within 4 weeks of, study entry.
* Known intolerance to mannitol.
* Uncontrolled hypertension - systolic blood pressure (BP) > 200 mmHg and or diastolic BP > 100 mmHg.
* Planned pulmonary rehabilitation.
* Have had major abdominal, chest or brain surgery in the three months prior to enrolment.
* Have known cerebral, aortic or abdominal aneurysm.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Respiratory Clinic - Sydney
Recruitment hospital [2] 0 0
Peninsula Medical Centre - Umina
Recruitment hospital [3] 0 0
Wesley Medical Centre - Auchenflower
Recruitment hospital [4] 0 0
Brisbane South Clinical Clinical Research Centre - Brisbane
Recruitment hospital [5] 0 0
Inala Health Centre - PO BOx 52, Inala
Recruitment hospital [6] 0 0
Flinders University - Bedford Park
Recruitment hospital [7] 0 0
Respiratory Research Foundation Clinical Trial Centre - Toorak Gardens
Recruitment hospital [8] 0 0
Peninsula Chest Clinic - Frankston
Recruitment hospital [9] 0 0
The rooms of Dr Chris Steinfort - Geelong
Recruitment hospital [10] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [11] 0 0
Rosebud Medical Centre - Rosebud
Recruitment hospital [12] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [13] 0 0
Mount Medical Centre - Perth
Recruitment postcode(s) [1] 0 0
2200 - Sydney
Recruitment postcode(s) [2] 0 0
2257 - Umina
Recruitment postcode(s) [3] 0 0
4066 - Auchenflower
Recruitment postcode(s) [4] 0 0
4152 - Brisbane
Recruitment postcode(s) [5] 0 0
4077 - PO BOx 52, Inala
Recruitment postcode(s) [6] 0 0
5042 - Bedford Park
Recruitment postcode(s) [7] 0 0
5056 - Toorak Gardens
Recruitment postcode(s) [8] 0 0
3199 - Frankston
Recruitment postcode(s) [9] 0 0
3220 - Geelong
Recruitment postcode(s) [10] 0 0
3004 - Melbourne
Recruitment postcode(s) [11] 0 0
3939 - Rosebud
Recruitment postcode(s) [12] 0 0
6009 - Nedlands
Recruitment postcode(s) [13] 0 0
6005 - Perth

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Syntara
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Alvin Ing, MBBS
Address 0 0
Bankstown Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00117182