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BI 671800 in Asthmatic Patients on Inhaled Corticosteroids

Primary Purpose

Asthma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BI 671800
Placebo
Montelukast
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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.

Sites / Locations

  • 1268.16.01004 Boehringer Ingelheim Investigational Site
  • 1268.16.01001 Boehringer Ingelheim Investigational Site
  • 1268.16.01006 Boehringer Ingelheim Investigational Site
  • 1268.16.01003 Boehringer Ingelheim Investigational Site
  • 1268.16.01002 Boehringer Ingelheim Investigational Site
  • 1268.16.01005 Boehringer Ingelheim Investigational Site
  • 1268.16.43002 Boehringer Ingelheim Investigational Site
  • 1268.16.49018 Boehringer Ingelheim Investigational Site
  • 1268.16.49014 Boehringer Ingelheim Investigational Site
  • 1268.16.49001 Boehringer Ingelheim Investigational Site
  • 1268.16.49004 Boehringer Ingelheim Investigational Site
  • 1268.16.49010 Boehringer Ingelheim Investigational Site
  • 1268.16.49012 Boehringer Ingelheim Investigational Site
  • 1268.16.49013 Boehringer Ingelheim Investigational Site
  • 1268.16.49016 Boehringer Ingelheim Investigational Site
  • 1268.16.49008 Boehringer Ingelheim Investigational Site
  • 1268.16.49005 Boehringer Ingelheim Investigational Site
  • 1268.16.49015 Boehringer Ingelheim Investigational Site
  • 1268.16.49011 Boehringer Ingelheim Investigational Site
  • 1268.16.49009 Boehringer Ingelheim Investigational Site
  • 1268.16.49017 Boehringer Ingelheim Investigational Site
  • 1268.16.49007 Boehringer Ingelheim Investigational Site
  • 1268.16.49006 Boehringer Ingelheim Investigational Site
  • 1268.16.49002 Boehringer Ingelheim Investigational Site
  • 1268.16.49003 Boehringer Ingelheim Investigational Site
  • 1268.16.39006 Boehringer Ingelheim Investigational Site
  • 1268.16.39007 Boehringer Ingelheim Investigational Site
  • 1268.16.39004 Boehringer Ingelheim Investigational Site
  • 1268.16.39001 Boehringer Ingelheim Investigational Site
  • 1268.16.82008 Boehringer Ingelheim Investigational Site
  • 1268.16.82009 Boehringer Ingelheim Investigational Site
  • 1268.16.82007 Boehringer Ingelheim Investigational Site
  • 1268.16.82006 Boehringer Ingelheim Investigational Site
  • 1268.16.82010 Boehringer Ingelheim Investigational Site
  • 1268.16.82001 Boehringer Ingelheim Investigational Site
  • 1268.16.82002 Boehringer Ingelheim Investigational Site
  • 1268.16.82004 Boehringer Ingelheim Investigational Site
  • 1268.16.82005 Boehringer Ingelheim Investigational Site
  • 1268.16.82003 Boehringer Ingelheim Investigational Site
  • 1268.16.64001 Boehringer Ingelheim Investigational Site
  • 1268.16.64003 Boehringer Ingelheim Investigational Site
  • 1268.16.46002 Boehringer Ingelheim Investigational Site
  • 1268.16.46001 Boehringer Ingelheim Investigational Site
  • 1268.16.46003 Boehringer Ingelheim Investigational Site
  • 1268.16.90002 Boehringer Ingelheim Investigational Site
  • 1268.16.90003 Boehringer Ingelheim Investigational Site
  • 1268.16.90004 Boehringer Ingelheim Investigational Site
  • 1268.16.90006 Boehringer Ingelheim Investigational Site
  • 1268.16.90001 Boehringer Ingelheim Investigational Site
  • 1268.16.44005 Boehringer Ingelheim Investigational Site
  • 1268.16.44004 Boehringer Ingelheim Investigational Site
  • 1268.16.44002 Boehringer Ingelheim Investigational Site
  • 1268.16.44003 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

BI 671800

Montelukast

Placebo

Arm Description

Patients receive BI 671800 capsules twice daily

Patients receive Montelukast encapsulated tablets once daily

Patients receive placebo capsules and/or encapsulated placebo tablets

Outcomes

Primary Outcome Measures

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
Forced expiratory volume in one second (FEV1) % predicted trough change from baseline (mean observed in the 2 weeks prior to treatment) after 6 weeks of treatment, where trough FEV1 % predicted was defined as the mean of the FEV1 % predicted trough values at 25 minutes and 10 minutes prior to dosing on clinic visit. MMRM in the statistical test comments is Mixed effects model with repeated measures.

Secondary Outcome Measures

Asthma Control Questionnaire (ACQ) Mean Change in Score on a Scale From Baseline After Six Weeks of Treatment
Asthma Control Questionnaire (ACQ) mean score change from baseline (mean ACQ score obtained at Week 0) after six weeks of treatment. The Asthma Control Questionnaire (ACQ) is a patient-reported outcome questionnaire containing 7 items. The items are equally weighted and the ACQ score is the mean of the 7 items and therefore between 0 (well controlled) and 6 (extremely poorly controlled) These questions based on recall of the previous 7 days comprise breathlessness, nocturnal waking, symptoms on waking, activity limitation, wheeze, frequency of Short-acting beta-adrenergic (SABA) use, and categorized pre-bronchodilator FEV1% predicted.

Full Information

First Posted
March 19, 2010
Last Updated
May 27, 2022
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT01103349
Brief Title
BI 671800 in Asthmatic Patients on Inhaled Corticosteroids
Official 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)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
April 20, 2010 (Actual)
Primary Completion Date
August 9, 2011 (Actual)
Study Completion Date
August 9, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary
This is a 6 week study to assess the effect of BI 671800 in patients with asthma. It is a double blind, parallel arm trial testing the safety and efficacy of BI 671800. The main objective is to assess the effect on lung function. The study will also provide data on the pharmacokinetics of BI 671800.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
243 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BI 671800
Arm Type
Experimental
Arm Description
Patients receive BI 671800 capsules twice daily
Arm Title
Montelukast
Arm Type
Active Comparator
Arm Description
Patients receive Montelukast encapsulated tablets once daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients receive placebo capsules and/or encapsulated placebo tablets
Intervention Type
Drug
Intervention Name(s)
BI 671800
Intervention Description
Double blind randomised parallel group study to assess efficacy and tolerability of BI 617800 in patients with symptomatic asthma
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patients receive placebo capsules and/or encapsulated tablets
Intervention Type
Drug
Intervention Name(s)
Montelukast
Intervention Description
Double blind randomised parallel group study to assess efficacy and tolerability of BI 671800 in patients with symptomatic asthma
Primary Outcome Measure Information:
Title
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
Description
Forced expiratory volume in one second (FEV1) % predicted trough change from baseline (mean observed in the 2 weeks prior to treatment) after 6 weeks of treatment, where trough FEV1 % predicted was defined as the mean of the FEV1 % predicted trough values at 25 minutes and 10 minutes prior to dosing on clinic visit. MMRM in the statistical test comments is Mixed effects model with repeated measures.
Time Frame
Measurements at baseline (mean observed in the 2 weeks prior to treatment) and at week 6 of treatment.
Secondary Outcome Measure Information:
Title
Asthma Control Questionnaire (ACQ) Mean Change in Score on a Scale From Baseline After Six Weeks of Treatment
Description
Asthma Control Questionnaire (ACQ) mean score change from baseline (mean ACQ score obtained at Week 0) after six weeks of treatment. The Asthma Control Questionnaire (ACQ) is a patient-reported outcome questionnaire containing 7 items. The items are equally weighted and the ACQ score is the mean of the 7 items and therefore between 0 (well controlled) and 6 (extremely poorly controlled) These questions based on recall of the previous 7 days comprise breathlessness, nocturnal waking, symptoms on waking, activity limitation, wheeze, frequency of Short-acting beta-adrenergic (SABA) use, and categorized pre-bronchodilator FEV1% predicted.
Time Frame
Measurements at baseline (mean ACQ score obtained at Week 0) and at week 6 of treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Signed informed consent consistent with ICH-GCP 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%. Stable inhaled corticosteroids (iCS) dose 3 months prior to screening. Diagnosis of asthma prior to 40 years. Asthma Control Questionnaire (ACQ) at least 1.5 at randomisation. Male or female 18 to 65 years. Non-smokers or ex-smokers (less than 10 pack years history) with negative cotinine screen. Able to perform pulmonary function testing. Exclusion criteria: Significant diseases other than asthma or allergic rhinitis. Hepatic transaminases or total bilirubin greater than 1.5 ULN. Hospitalisation for asthma exacerbation or asthma related intubation within 3 months. Uncontrolled asthma on iCS + other controller. Respiratory tract infection or exacerbation within 4 weeks. FEV1 less than 40%, more than 12 puffs rescue salbutamol on more than two consecutive days, or asthma exacerbation during run-in period. Participation in another interventional study. Pregnant or nursing women. Women of child bearing potential not using appropriate methods of birth control as defined by the study protocol.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
1268.16.01004 Boehringer Ingelheim Investigational Site
City
Denver
State/Province
Colorado
Country
United States
Facility Name
1268.16.01001 Boehringer Ingelheim Investigational Site
City
North Dartmouth
State/Province
Massachusetts
Country
United States
Facility Name
1268.16.01006 Boehringer Ingelheim Investigational Site
City
Plymouth
State/Province
Minnesota
Country
United States
Facility Name
1268.16.01003 Boehringer Ingelheim Investigational Site
City
Portland
State/Province
Oregon
Country
United States
Facility Name
1268.16.01002 Boehringer Ingelheim Investigational Site
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
1268.16.01005 Boehringer Ingelheim Investigational Site
City
El Paso
State/Province
Texas
Country
United States
Facility Name
1268.16.43002 Boehringer Ingelheim Investigational Site
City
Feldbach
Country
Austria
Facility Name
1268.16.49018 Boehringer Ingelheim Investigational Site
City
Aschaffenburg
Country
Germany
Facility Name
1268.16.49014 Boehringer Ingelheim Investigational Site
City
Bamberg
Country
Germany
Facility Name
1268.16.49001 Boehringer Ingelheim Investigational Site
City
Berlin
Country
Germany
Facility Name
1268.16.49004 Boehringer Ingelheim Investigational Site
City
Berlin
Country
Germany
Facility Name
1268.16.49010 Boehringer Ingelheim Investigational Site
City
Berlin
Country
Germany
Facility Name
1268.16.49012 Boehringer Ingelheim Investigational Site
City
Berlin
Country
Germany
Facility Name
1268.16.49013 Boehringer Ingelheim Investigational Site
City
Berlin
Country
Germany
Facility Name
1268.16.49016 Boehringer Ingelheim Investigational Site
City
Berlin
Country
Germany
Facility Name
1268.16.49008 Boehringer Ingelheim Investigational Site
City
Erfurt
Country
Germany
Facility Name
1268.16.49005 Boehringer Ingelheim Investigational Site
City
Frankfurt
Country
Germany
Facility Name
1268.16.49015 Boehringer Ingelheim Investigational Site
City
Frankfurt
Country
Germany
Facility Name
1268.16.49011 Boehringer Ingelheim Investigational Site
City
Hamburg
Country
Germany
Facility Name
1268.16.49009 Boehringer Ingelheim Investigational Site
City
Hannover
Country
Germany
Facility Name
1268.16.49017 Boehringer Ingelheim Investigational Site
City
Hannover
Country
Germany
Facility Name
1268.16.49007 Boehringer Ingelheim Investigational Site
City
Koblenz
Country
Germany
Facility Name
1268.16.49006 Boehringer Ingelheim Investigational Site
City
Lübeck
Country
Germany
Facility Name
1268.16.49002 Boehringer Ingelheim Investigational Site
City
Rüdersdorf
Country
Germany
Facility Name
1268.16.49003 Boehringer Ingelheim Investigational Site
City
Weinheim
Country
Germany
Facility Name
1268.16.39006 Boehringer Ingelheim Investigational Site
City
Ferrara
Country
Italy
Facility Name
1268.16.39007 Boehringer Ingelheim Investigational Site
City
Milano
Country
Italy
Facility Name
1268.16.39004 Boehringer Ingelheim Investigational Site
City
Pietra Ligure (SV)
Country
Italy
Facility Name
1268.16.39001 Boehringer Ingelheim Investigational Site
City
Pisa
Country
Italy
Facility Name
1268.16.82008 Boehringer Ingelheim Investigational Site
City
Anyang
Country
Korea, Republic of
Facility Name
1268.16.82009 Boehringer Ingelheim Investigational Site
City
Bucheon
Country
Korea, Republic of
Facility Name
1268.16.82007 Boehringer Ingelheim Investigational Site
City
Cheongju
Country
Korea, Republic of
Facility Name
1268.16.82006 Boehringer Ingelheim Investigational Site
City
Daegu
Country
Korea, Republic of
Facility Name
1268.16.82010 Boehringer Ingelheim Investigational Site
City
Gwangju
Country
Korea, Republic of
Facility Name
1268.16.82001 Boehringer Ingelheim Investigational Site
City
Seoul
Country
Korea, Republic of
Facility Name
1268.16.82002 Boehringer Ingelheim Investigational Site
City
Seoul
Country
Korea, Republic of
Facility Name
1268.16.82004 Boehringer Ingelheim Investigational Site
City
Seoul
Country
Korea, Republic of
Facility Name
1268.16.82005 Boehringer Ingelheim Investigational Site
City
Seoul
Country
Korea, Republic of
Facility Name
1268.16.82003 Boehringer Ingelheim Investigational Site
City
Suwon
Country
Korea, Republic of
Facility Name
1268.16.64001 Boehringer Ingelheim Investigational Site
City
Christchurch NZ
Country
New Zealand
Facility Name
1268.16.64003 Boehringer Ingelheim Investigational Site
City
Greenlane East Auckland
Country
New Zealand
Facility Name
1268.16.46002 Boehringer Ingelheim Investigational Site
City
Göteborg
Country
Sweden
Facility Name
1268.16.46001 Boehringer Ingelheim Investigational Site
City
Lund
Country
Sweden
Facility Name
1268.16.46003 Boehringer Ingelheim Investigational Site
City
Örebro
Country
Sweden
Facility Name
1268.16.90002 Boehringer Ingelheim Investigational Site
City
Bursa
Country
Turkey
Facility Name
1268.16.90003 Boehringer Ingelheim Investigational Site
City
Istanbul
Country
Turkey
Facility Name
1268.16.90004 Boehringer Ingelheim Investigational Site
City
Istanbul
Country
Turkey
Facility Name
1268.16.90006 Boehringer Ingelheim Investigational Site
City
Istanbul
Country
Turkey
Facility Name
1268.16.90001 Boehringer Ingelheim Investigational Site
City
Mersin
Country
Turkey
Facility Name
1268.16.44005 Boehringer Ingelheim Investigational Site
City
Chertsey
Country
United Kingdom
Facility Name
1268.16.44004 Boehringer Ingelheim Investigational Site
City
London
Country
United Kingdom
Facility Name
1268.16.44002 Boehringer Ingelheim Investigational Site
City
Manchester
Country
United Kingdom
Facility Name
1268.16.44003 Boehringer Ingelheim Investigational Site
City
Southampton
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://www.mystudywindow.com/
Description
Related Info

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BI 671800 in Asthmatic Patients on Inhaled Corticosteroids

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