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/NCT01103349




Registration number
NCT01103349
Ethics application status
Date submitted
19/03/2010
Date registered
14/04/2010
Date last updated
31/05/2022

Titles & IDs
Public title
BI 671800 in Asthmatic Patients on Inhaled Corticosteroids
Scientific title
Randomised, Double Blind, Double Dummy, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of 6 Weeks of Oral BI 671800 ED Twice Daily (b.i.d.), Montelukast Once Daily (q.d.) or Placebo in Symptomatic Asthmatic Patients on Low Dose Fluticasone Propionate MDI (Metered Dose Inhaler)
Secondary ID [1] 0 0
2009-014551-80
Secondary ID [2] 0 0
1268.16
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 - BI 671800
Treatment: Drugs - Placebo
Treatment: Drugs - Montelukast

Experimental: BI 671800 - Patients receive BI 671800 capsules twice daily

Active comparator: Montelukast - Patients receive Montelukast encapsulated tablets once daily

Placebo comparator: Placebo - Patients receive placebo capsules and/or encapsulated placebo tablets


Treatment: Drugs: BI 671800
Double blind randomised parallel group study to assess efficacy and tolerability of BI 617800 in patients with symptomatic asthma

Treatment: Drugs: Placebo
Patients receive placebo capsules and/or encapsulated tablets

Treatment: Drugs: Montelukast
Double blind randomised parallel group study to assess efficacy and tolerability of BI 671800 in patients with symptomatic asthma
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Forced Expiratory Volume in One Second (FEV1) % Predicted Trough Change From Baseline (Mean Observed in the 2 Weeks Prior to Treatment) After Six Weeks of Treatment
Timepoint [1] 0 0
Measurements at baseline (mean observed in the 2 weeks prior to treatment) and at week 6 of treatment.
Secondary outcome [1] 0 0
Asthma Control Questionnaire (ACQ) Mean Change in Score on a Scale From Baseline After Six Weeks of Treatment
Timepoint [1] 0 0
Measurements at baseline (mean ACQ score obtained at Week 0) and at week 6 of treatment.

Eligibility
Key inclusion criteria
Inclusion criteria:

1. Signed informed consent consistent with ICH-GCP
2. Three month history of reversible (12% and 200 mL in forced expiratory volume in one second - FEV1) asthma (according to GINA) with following spirometry at randomisation: FEV1 60%- 85%.
3. Stable inhaled corticosteroids (iCS) dose 3 months prior to screening.
4. Diagnosis of asthma prior to 40 years.
5. Asthma Control Questionnaire (ACQ) at least 1.5 at randomisation.
6. Male or female 18 to 65 years.
7. Non-smokers or ex-smokers (less than 10 pack years history) with negative cotinine screen.
8. Able to perform pulmonary function testing.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

1. Significant diseases other than asthma or allergic rhinitis.
2. Hepatic transaminases or total bilirubin greater than 1.5 ULN.
3. Hospitalisation for asthma exacerbation or asthma related intubation within 3 months.
4. Uncontrolled asthma on iCS + other controller.
5. Respiratory tract infection or exacerbation within 4 weeks.
6. FEV1 less than 40%, more than 12 puffs rescue salbutamol on more than two consecutive days, or asthma exacerbation during run-in period.
7. Participation in another interventional study.
8. Pregnant or nursing women.
9. Women of child bearing potential not using appropriate methods of birth control as defined by the study protocol.

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 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
20/04/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/08/2011
Sample size
Target
Accrual to date
Final
243
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
Minnesota
Country [4] 0 0
United States of America
State/province [4] 0 0
Oregon
Country [5] 0 0
United States of America
State/province [5] 0 0
South Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
Austria
State/province [7] 0 0
Feldbach
Country [8] 0 0
Germany
State/province [8] 0 0
Aschaffenburg
Country [9] 0 0
Germany
State/province [9] 0 0
Bamberg
Country [10] 0 0
Germany
State/province [10] 0 0
Berlin
Country [11] 0 0
Germany
State/province [11] 0 0
Erfurt
Country [12] 0 0
Germany
State/province [12] 0 0
Frankfurt
Country [13] 0 0
Germany
State/province [13] 0 0
Hamburg
Country [14] 0 0
Germany
State/province [14] 0 0
Hannover
Country [15] 0 0
Germany
State/province [15] 0 0
Koblenz
Country [16] 0 0
Germany
State/province [16] 0 0
Lübeck
Country [17] 0 0
Germany
State/province [17] 0 0
Rüdersdorf
Country [18] 0 0
Germany
State/province [18] 0 0
Weinheim
Country [19] 0 0
Italy
State/province [19] 0 0
Ferrara
Country [20] 0 0
Italy
State/province [20] 0 0
Milano
Country [21] 0 0
Italy
State/province [21] 0 0
Pietra Ligure (SV)
Country [22] 0 0
Italy
State/province [22] 0 0
Pisa
Country [23] 0 0
Korea, Republic of
State/province [23] 0 0
Anyang
Country [24] 0 0
Korea, Republic of
State/province [24] 0 0
Bucheon
Country [25] 0 0
Korea, Republic of
State/province [25] 0 0
Cheongju
Country [26] 0 0
Korea, Republic of
State/province [26] 0 0
Daegu
Country [27] 0 0
Korea, Republic of
State/province [27] 0 0
Gwangju
Country [28] 0 0
Korea, Republic of
State/province [28] 0 0
Seoul
Country [29] 0 0
Korea, Republic of
State/province [29] 0 0
Suwon
Country [30] 0 0
New Zealand
State/province [30] 0 0
Christchurch NZ
Country [31] 0 0
New Zealand
State/province [31] 0 0
Greenlane East Auckland
Country [32] 0 0
Sweden
State/province [32] 0 0
Göteborg
Country [33] 0 0
Sweden
State/province [33] 0 0
Lund
Country [34] 0 0
Sweden
State/province [34] 0 0
Örebro
Country [35] 0 0
Turkey
State/province [35] 0 0
Bursa
Country [36] 0 0
Turkey
State/province [36] 0 0
Istanbul
Country [37] 0 0
Turkey
State/province [37] 0 0
Mersin
Country [38] 0 0
United Kingdom
State/province [38] 0 0
Chertsey
Country [39] 0 0
United Kingdom
State/province [39] 0 0
London
Country [40] 0 0
United Kingdom
State/province [40] 0 0
Manchester
Country [41] 0 0
United Kingdom
State/province [41] 0 0
Southampton

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

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/NCT01103349