BI 671800 in Asthmatic Patients on Inhaled Corticosteroids

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)

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: BI 671800; Drug: Montelukast; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 243
• Phase: Phase 2

Contacts and Locations

Study Locations

• Austria
  • Feldbach, Austria
    • 1268.16.43002 Boehringer Ingelheim Investigational Site
• Germany
  • Aschaffenburg, Germany
    • 1268.16.49018 Boehringer Ingelheim Investigational Site
  • Bamberg, Germany
    • 1268.16.49014 Boehringer Ingelheim Investigational Site
  • Berlin, Germany
    • 1268.16.49001 Boehringer Ingelheim Investigational Site
  • Berlin, Germany
    • 1268.16.49004 Boehringer Ingelheim Investigational Site
  • Berlin, Germany
    • 1268.16.49010 Boehringer Ingelheim Investigational Site
  • Berlin, Germany
    • 1268.16.49012 Boehringer Ingelheim Investigational Site
  • Berlin, Germany
    • 1268.16.49013 Boehringer Ingelheim Investigational Site
  • Berlin, Germany
    • 1268.16.49016 Boehringer Ingelheim Investigational Site
  • Erfurt, Germany
    • 1268.16.49008 Boehringer Ingelheim Investigational Site
  • Frankfurt, Germany
    • 1268.16.49005 Boehringer Ingelheim Investigational Site
  • Frankfurt, Germany
    • 1268.16.49015 Boehringer Ingelheim Investigational Site
  • Hamburg, Germany
    • 1268.16.49011 Boehringer Ingelheim Investigational Site
  • Hannover, Germany
    • 1268.16.49009 Boehringer Ingelheim Investigational Site
  • Hannover, Germany
    • 1268.16.49017 Boehringer Ingelheim Investigational Site
  • Koblenz, Germany
    • 1268.16.49007 Boehringer Ingelheim Investigational Site
  • Lübeck, Germany
    • 1268.16.49006 Boehringer Ingelheim Investigational Site
  • Rüdersdorf, Germany
    • 1268.16.49002 Boehringer Ingelheim Investigational Site
  • Weinheim, Germany
    • 1268.16.49003 Boehringer Ingelheim Investigational Site
• Italy
  • Ferrara, Italy
    • 1268.16.39006 Boehringer Ingelheim Investigational Site
  • Milano, Italy
    • 1268.16.39007 Boehringer Ingelheim Investigational Site
  • Pietra Ligure (SV), Italy
    • 1268.16.39004 Boehringer Ingelheim Investigational Site
  • Pisa, Italy
    • 1268.16.39001 Boehringer Ingelheim Investigational Site
• Korea, Republic of
  • Anyang, Korea, Republic of
    • 1268.16.82008 Boehringer Ingelheim Investigational Site
  • Bucheon, Korea, Republic of
    • 1268.16.82009 Boehringer Ingelheim Investigational Site
  • Cheongju, Korea, Republic of
    • 1268.16.82007 Boehringer Ingelheim Investigational Site
  • Daegu, Korea, Republic of
    • 1268.16.82006 Boehringer Ingelheim Investigational Site
  • Gwangju, Korea, Republic of
    • 1268.16.82010 Boehringer Ingelheim Investigational Site
  • Seoul, Korea, Republic of
    • 1268.16.82001 Boehringer Ingelheim Investigational Site
  • Seoul, Korea, Republic of
    • 1268.16.82002 Boehringer Ingelheim Investigational Site
  • Seoul, Korea, Republic of
    • 1268.16.82004 Boehringer Ingelheim Investigational Site
  • Seoul, Korea, Republic of
    • 1268.16.82005 Boehringer Ingelheim Investigational Site
  • Suwon, Korea, Republic of
    • 1268.16.82003 Boehringer Ingelheim Investigational Site
• New Zealand
  • Christchurch NZ, New Zealand
    • 1268.16.64001 Boehringer Ingelheim Investigational Site
  • Greenlane East Auckland, New Zealand
    • 1268.16.64003 Boehringer Ingelheim Investigational Site
• Sweden
  • Göteborg, Sweden
    • 1268.16.46002 Boehringer Ingelheim Investigational Site
  • Lund, Sweden
    • 1268.16.46001 Boehringer Ingelheim Investigational Site
  • Örebro, Sweden
    • 1268.16.46003 Boehringer Ingelheim Investigational Site
• Turkey
  • Bursa, Turkey
    • 1268.16.90002 Boehringer Ingelheim Investigational Site
  • Istanbul, Turkey
    • 1268.16.90003 Boehringer Ingelheim Investigational Site
  • Istanbul, Turkey
    • 1268.16.90004 Boehringer Ingelheim Investigational Site
  • Istanbul, Turkey
    • 1268.16.90006 Boehringer Ingelheim Investigational Site
  • Mersin, Turkey
    • 1268.16.90001 Boehringer Ingelheim Investigational Site
• United Kingdom
  • Chertsey, United Kingdom
    • 1268.16.44005 Boehringer Ingelheim Investigational Site
  • London, United Kingdom
    • 1268.16.44004 Boehringer Ingelheim Investigational Site
  • Manchester, United Kingdom
    • 1268.16.44002 Boehringer Ingelheim Investigational Site
  • Southampton, United Kingdom
    • 1268.16.44003 Boehringer Ingelheim Investigational Site
• United States
  • Colorado
    • Denver, Colorado, United States
      • 1268.16.01004 Boehringer Ingelheim Investigational Site
  • Massachusetts
    • North Dartmouth, Massachusetts, United States
      • 1268.16.01001 Boehringer Ingelheim Investigational Site
  • Minnesota
    • Plymouth, Minnesota, United States
      • 1268.16.01006 Boehringer Ingelheim Investigational Site
  • Oregon
    • Portland, Oregon, United States
      • 1268.16.01003 Boehringer Ingelheim Investigational Site
  • South Carolina
    • Charleston, South Carolina, United States
      • 1268.16.01002 Boehringer Ingelheim Investigational Site
  • Texas
    • El Paso, Texas, United States
      • 1268.16.01005 Boehringer Ingelheim Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BI 671800; Patients receive BI 671800 capsules twice daily	Drug: BI 671800; Double blind randomised parallel group study to assess efficacy and tolerability of BI 617800 in patients with symptomatic asthma
Active Comparator: Montelukast; Patients receive Montelukast encapsulated tablets once daily	Drug: Montelukast; Double blind randomised parallel group study to assess efficacy and tolerability of BI 671800 in patients with symptomatic asthma
Placebo Comparator: Placebo; Patients receive placebo capsules and/or encapsulated placebo tablets	Drug: Placebo; Patients receive placebo capsules and/or encapsulated tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Measurements at baseline (mean observed in the 2 weeks prior to treatment) and at week 6 of treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Measurements at baseline (mean ACQ score obtained at Week 0) and at week 6 of treatment.

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2010
• Primary Completion (Actual): August 9, 2011
• Study Completion (Actual): August 9, 2011

Study Registration Dates

• First Submitted: March 19, 2010
• First Submitted That Met QC Criteria: April 13, 2010
• First Posted (Estimate): April 14, 2010

Study Record Updates

• Last Update Posted (Actual): May 31, 2022
• Last Update Submitted That Met QC Criteria: May 27, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Asthmatic Agents; Respiratory System Agents; Leukotriene Antagonists; Hormone Antagonists; Cytochrome P-450 CYP1A2 Inducers; Cytochrome P-450 Enzyme Inducers; Montelukast
• Other Study ID Numbers: 1268.16; 2009-014551-80 (EudraCT Number: EudraCT)