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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01634152




Registration number
NCT01634152
Ethics application status
Date submitted
3/07/2012
Date registered
6/07/2012
Date last updated
29/01/2016

Titles & IDs
Public title
Efficacy and Safety of 2 Doses of Tiotropium Respimat® Compared to Placebo in Children With Severe Persistent Asthma
Scientific title
A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate Efficacy and Safety of Tiotropium Inhalation Solution (2.5 mcg and 5 mcg) Delivered Via Respimat® Inhaler Once Daily in the Evening Over 12 Weeks as add-on Controller Therapy on Top of Usual Care in Children (6 to 11 Years Old) With Severe Persistent Asthma
Secondary ID [1] 0 0
2011-001777-43
Secondary ID [2] 0 0
205.446
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - Tiotropium low dose mcg
Treatment: Drugs - Tiotropium high dose

Placebo comparator: Placebo QD -

Experimental: Tiotropium low dose QD -

Experimental: Tiotropium medium dose QD -


Treatment: Drugs: Placebo
2 actuations once daily in the evening

Treatment: Drugs: Tiotropium low dose mcg
2 actuations once daily in the evening

Treatment: Drugs: Tiotropium high dose
2 actuations once daily in the evening
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
FEV1 Peak(0-3h) Change From Baseline
Timepoint [1] 0 0
Baseline and 12 weeks
Secondary outcome [1] 0 0
Trough FEV1 Change From Baseline
Timepoint [1] 0 0
Baseline and 12 weeks
Secondary outcome [2] 0 0
FVC Peak(0-3h) Change From Baseline
Timepoint [2] 0 0
Baseline and 12 weeks
Secondary outcome [3] 0 0
Trough FVC Change From Baseline
Timepoint [3] 0 0
Baseline and 12 weeks
Secondary outcome [4] 0 0
FEV1 AUC (0-3h) Change From Baseline
Timepoint [4] 0 0
Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 12 weeks
Secondary outcome [5] 0 0
FVC AUC (0-3h) Change From Baseline
Timepoint [5] 0 0
Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 12 weeks
Secondary outcome [6] 0 0
FEV1 Change From Baseline at Each Individual Timepoint
Timepoint [6] 0 0
Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 12 weeks
Secondary outcome [7] 0 0
FVC Change From Baseline at Each Individual Timepoint
Timepoint [7] 0 0
Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 12 weeks
Secondary outcome [8] 0 0
Control of Asthma as Assessed by ACQ-IA Total Score
Timepoint [8] 0 0
Baseline and 12 weeks
Secondary outcome [9] 0 0
ACQ-IA Total Score Responders
Timepoint [9] 0 0
12 weeks
Secondary outcome [10] 0 0
Use of PRN Rescue Medication Per Day
Timepoint [10] 0 0
Baseline and 12 weeks
Secondary outcome [11] 0 0
Use of PRN Rescue Medication During the Daytime
Timepoint [11] 0 0
Baseline and 12 weeks
Secondary outcome [12] 0 0
Use of PRN Rescue Medication During the Night-time
Timepoint [12] 0 0
Baseline and 12 weeks
Secondary outcome [13] 0 0
Peak Expiratory Flow (PEF) a.m. Change From Baseline
Timepoint [13] 0 0
Baseline and 12 weeks
Secondary outcome [14] 0 0
Peak Expiratory Flow (PEF) p.m. Change From Baseline
Timepoint [14] 0 0
Baseline and 12 weeks
Secondary outcome [15] 0 0
Peak Expiratory Flow (PEF) Variability Change From Baseline
Timepoint [15] 0 0
Baseline and 12 weeks
Secondary outcome [16] 0 0
FEV1 a.m. Change From Baseline
Timepoint [16] 0 0
Baseline and 12 weeks
Secondary outcome [17] 0 0
FEV1 p.m. Change From Baseline
Timepoint [17] 0 0
Baseline and 12 weeks
Secondary outcome [18] 0 0
Change From Baseline in Nighttime Awakenings
Timepoint [18] 0 0
Baseline and 12 weeks
Secondary outcome [19] 0 0
Change From Baseline in Morning Asthma Symptoms
Timepoint [19] 0 0
Baseline and 12 weeks
Secondary outcome [20] 0 0
Change From Baseline in Daytime Asthma Symptoms
Timepoint [20] 0 0
Baseline and 12 weeks
Secondary outcome [21] 0 0
Change From Baseline in Daytime Activity Limitations
Timepoint [21] 0 0
Baseline and 12 weeks
Secondary outcome [22] 0 0
Change From Baseline in Daytime Experiences of Shortness of Breath
Timepoint [22] 0 0
Baseline and 12 weeks
Secondary outcome [23] 0 0
Change From Baseline in Daytime Experiences of Wheeze or Cough
Timepoint [23] 0 0
Baseline and 12 weeks
Secondary outcome [24] 0 0
Change From Baseline in Asthma Symptom-free Days
Timepoint [24] 0 0
Baseline and 12 weeks

Eligibility
Key inclusion criteria
Inclusion criteria:

Inclusion criteria are:

1. All patients' parent(s) (or legal guardian) must sign and date an informed consent prior to participation in the trial. In addition, an informed assent suitable for this age group has to be obtained from patients. A separate informed consent/assent is required for pharmacogenomic sampling.
2. Male or female patients between 6 and 11 years of age.
3. All patients must have at least a 6-month history of asthma.
4. All patients must have been on maintenance treatment with an inhaled corticosteroid either at stable high dose in combination with another controller medication, OR at stable medium dose in combination with two other controller medications, for at least 4 weeks before Visit 1.
5. All patients must be symptomatic (partly controlled) at Visit 1 and prior to randomisation at Visit 2 as defined by an Asthma Control Questionnaire (ACQ-IA) mean score >= 1.5.
6. All patients must have a pre-bronchodilator forced expiratory volume in one second (FEV1) >= 60% and <= 90% of predicted normal at Visit 1.
7. Variation of absolute FEV1 values of Visit 1 (pre-bronchodilator, considered as 100%) as compared to Visit 2 (pre-dose) must be within ± 30%.
8. All patients must confirm the diagnosis of asthma by bronchodilator reversibility at Visit 1, resulting in an increase in FEV1 of >= 12% 15 to 30 minutes after 200 mcg salbutamol/albuterol.
9. Patients must be able to use the Respimat inhaler correctly.
10. Patients must be able to perform all trial related procedures including technically acceptable pulmonary function tests and use of electronic diary/peak flow meter (diary compliance of at least 80% is required).
Minimum age
6 Years
Maximum age
11 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

Exclusion criteria are:

1. Patients with a significant disease other than asthma.
2. Patients with a clinically relevant abnormal haematology or blood chemistry at screening.
3. Patients with a history of congenital or acquired heart disease, or patients who have been hospitalised for cardiac syncope or failure during the past year.
4. Patients with any unstable or life-threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year.
5. Patients with a malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years.
6. Patients with known active tuberculosis.
7. Patients who have undergone thoracotomy with pulmonary resection.
8. Patients who are currently in a pulmonary rehabilitation program or have completed a pulmonary rehabilitation program in the six weeks prior to Visit 1.
9. Patients with known hypersensitivity to anticholinergic drugs, BAC, EDTA or any other components of the inhalation solution used with the Respimat inhaler.
10. Pregnant or nursing female patients, including postmenarchal girls with a positive urine pregnancy test at Visit 1.
11. Postmenarchal girls of child-bearing potential not using a highly effective method of birth control.
12. Patients who have been treated with systemic corticosteroids within four weeks prior to Visit 1.
13. Patients who have been treated with systemic beta-adrenergics within four weeks prior to Visit 1.
14. Patients who have been treated with oral beta-blocker medication within four weeks prior to Visit 1 and/or during the screening period.
15. Patients who have been treated with inhaled long-acting anticholinergics or systemic anticholinergic treatment within four weeks prior to Visit 1 and/or during the screening period, or who have been treated with inhaled short-acting anticholinergics within two weeks prior to Visit 1.
16. Patients who have been treated with short-acting theophylline preparations within two weeks prior to Visit 1.
17. Patients who have been treated with non-approved and according to international guidelines not recommended experimental drugs for routine asthma therapy within four weeks prior to Visit 1 and/or during the screening period.
18. Patients who have taken an investigational drug within six half lives according to the investigator's information, or four weeks (whichever is greater) prior to Visit 1 and/or during the screening period.
19. Patients who have previously been randomised in this trial or are currently participating in another trial.
20. Patients with any acute asthma exacerbation or respiratory tract infection in the four weeks prior to Visit 1 and/or in the four weeks prior to Visit 2. In case of an asthma deterioration occurring in the four weeks prior to Visit 1 and/or in the four weeks prior to Visit 2, the visit must be postponed.
21. Patients requiring six or more puffs of rescue medication per day on more than two consecutive days in the four weeks prior to Visit 1 and/or in the four weeks prior to Visit 2. In case of an asthma deterioration occurring in the four weeks prior to Visit 1 and/or in the four weeks prior to Visit 2, the visit must be postponed.
22. Patients who are unable to comply with medication restrictions prior to Visit 1 and/or prior to Visit 2.
23. Patients with a known narrow-angle glaucoma, or any other disease where anticholinergic treatment is contraindicated.
24. Patients with moderate to severe renal impairment, as defined by a creatinine clearance <50 mL/min/1.73 m2 BSA, as tiotropium is a predominantly renally excreted drug.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
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
1/07/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2015
Sample size
Target
Accrual to date
Final
401
Recruitment in Australia
Recruitment state(s)
QLD,WA
Recruitment hospital [1] 0 0
205.446.61003 Boehringer Ingelheim Investigational Site - Herston
Recruitment hospital [2] 0 0
205.446.61001 Boehringer Ingelheim Investigational Site - Perth
Recruitment postcode(s) [1] 0 0
- Herston
Recruitment postcode(s) [2] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
Missouri
Country [5] 0 0
United States of America
State/province [5] 0 0
Ohio
Country [6] 0 0
United States of America
State/province [6] 0 0
Oklahoma
Country [7] 0 0
United States of America
State/province [7] 0 0
South Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
Argentina
State/province [9] 0 0
Buenos Aires
Country [10] 0 0
Argentina
State/province [10] 0 0
Capital Federal
Country [11] 0 0
Argentina
State/province [11] 0 0
Mar del Plata
Country [12] 0 0
Argentina
State/province [12] 0 0
Mendoza
Country [13] 0 0
Argentina
State/province [13] 0 0
San Miguel de Tucuman
Country [14] 0 0
Belgium
State/province [14] 0 0
Antwerpen
Country [15] 0 0
Belgium
State/province [15] 0 0
Brugge
Country [16] 0 0
Belgium
State/province [16] 0 0
Namur
Country [17] 0 0
Brazil
State/province [17] 0 0
Curitiba
Country [18] 0 0
Brazil
State/province [18] 0 0
Goiânia
Country [19] 0 0
Brazil
State/province [19] 0 0
Porto Alegre
Country [20] 0 0
Brazil
State/province [20] 0 0
Sao Paulo
Country [21] 0 0
Canada
State/province [21] 0 0
Ontario
Country [22] 0 0
Canada
State/province [22] 0 0
Quebec
Country [23] 0 0
Czech Republic
State/province [23] 0 0
Jablonec nad Nisou
Country [24] 0 0
Czech Republic
State/province [24] 0 0
Jihlava
Country [25] 0 0
Czech Republic
State/province [25] 0 0
Prague
Country [26] 0 0
Germany
State/province [26] 0 0
Berlin
Country [27] 0 0
Germany
State/province [27] 0 0
Bochum
Country [28] 0 0
Germany
State/province [28] 0 0
Dresden
Country [29] 0 0
Germany
State/province [29] 0 0
Frankfurt
Country [30] 0 0
Germany
State/province [30] 0 0
Koblenz
Country [31] 0 0
Germany
State/province [31] 0 0
Marburg
Country [32] 0 0
Germany
State/province [32] 0 0
Mönchengladbach
Country [33] 0 0
Guatemala
State/province [33] 0 0
Guatemala
Country [34] 0 0
Hungary
State/province [34] 0 0
Ajka
Country [35] 0 0
Hungary
State/province [35] 0 0
Budapest
Country [36] 0 0
Hungary
State/province [36] 0 0
Nagyatad
Country [37] 0 0
Hungary
State/province [37] 0 0
Szeged
Country [38] 0 0
Latvia
State/province [38] 0 0
Baldone
Country [39] 0 0
Latvia
State/province [39] 0 0
Balvi
Country [40] 0 0
Latvia
State/province [40] 0 0
Daugavpils
Country [41] 0 0
Latvia
State/province [41] 0 0
Jekabpils
Country [42] 0 0
Latvia
State/province [42] 0 0
Ogre
Country [43] 0 0
Latvia
State/province [43] 0 0
Rezekne
Country [44] 0 0
Latvia
State/province [44] 0 0
Riga
Country [45] 0 0
Lithuania
State/province [45] 0 0
Siauliai
Country [46] 0 0
Lithuania
State/province [46] 0 0
Taurage
Country [47] 0 0
Lithuania
State/province [47] 0 0
Utena
Country [48] 0 0
Lithuania
State/province [48] 0 0
Vilnius
Country [49] 0 0
Poland
State/province [49] 0 0
Bialystok
Country [50] 0 0
Poland
State/province [50] 0 0
Lodz
Country [51] 0 0
Poland
State/province [51] 0 0
Lublin
Country [52] 0 0
Poland
State/province [52] 0 0
Tarnow
Country [53] 0 0
Romania
State/province [53] 0 0
Bucharest
Country [54] 0 0
Russian Federation
State/province [54] 0 0
Moscow
Country [55] 0 0
Russian Federation
State/province [55] 0 0
Novosibirsk
Country [56] 0 0
Russian Federation
State/province [56] 0 0
St. Petersburg
Country [57] 0 0
Russian Federation
State/province [57] 0 0
Yaroslavl
Country [58] 0 0
Slovakia
State/province [58] 0 0
Kosice
Country [59] 0 0
Slovakia
State/province [59] 0 0
Presov
Country [60] 0 0
Slovakia
State/province [60] 0 0
Spisska Nova Ves
Country [61] 0 0
Ukraine
State/province [61] 0 0
Chernivtsi
Country [62] 0 0
Ukraine
State/province [62] 0 0
Dnipropetrovsk
Country [63] 0 0
Ukraine
State/province [63] 0 0
Donetsk
Country [64] 0 0
Ukraine
State/province [64] 0 0
Kharkiv
Country [65] 0 0
Ukraine
State/province [65] 0 0
Kiev
Country [66] 0 0
Ukraine
State/province [66] 0 0
Kriviy Rig
Country [67] 0 0
Ukraine
State/province [67] 0 0
Lviv
Country [68] 0 0
Ukraine
State/province [68] 0 0
Odesa
Country [69] 0 0
Ukraine
State/province [69] 0 0
Vinnytsya
Country [70] 0 0
Ukraine
State/province [70] 0 0
Zaporizhya
Country [71] 0 0
Ukraine
State/province [71] 0 0
Zaporizhzhya

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boehringer Ingelheim
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Pfizer
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim
Address 0 0
Boehringer Ingelheim
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 are available at https://clinicaltrials.gov/study/NCT01634152