BI 671800 in Asthmatic Patients on Inhaled Corticosteroids

NCT01103349 | Completed Phase 2 Results

• 2 other identifiers: 1268.162009-014551-80
• Study Type: interventional
• Target: 243
• Locations: 9 countries
• Sites: 53

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Asthma Control Questionnaire (ACQ) Mean Change in Score on a Scale From Baseline After Six Weeks of Treatment

  Measurements at baseline (mean ACQ score obtained at Week 0) and at week 6 of treatment.

Study Arms (3)

BI 671800

EXPERIMENTAL

Patients receive BI 671800 capsules twice daily

Drug: BI 671800

Montelukast

ACTIVE COMPARATOR

Patients receive Montelukast encapsulated tablets once daily

Drug: Montelukast

Placebo

PLACEBO COMPARATOR

Patients receive placebo capsules and/or encapsulated placebo tablets

Drug: Placebo

Interventions

BI 671800 DRUG

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

BI 671800

Placebo DRUG

Patients receive placebo capsules and/or encapsulated tablets

Placebo

Montelukast DRUG

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

Montelukast

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (53)

1268.16.01004 Boehringer Ingelheim Investigational Site

Denver, Colorado, United States

Location

1268.16.01001 Boehringer Ingelheim Investigational Site

North Dartmouth, Massachusetts, United States

Location

1268.16.01006 Boehringer Ingelheim Investigational Site

Plymouth, Minnesota, United States

Location

1268.16.01003 Boehringer Ingelheim Investigational Site

Portland, Oregon, United States

Location

1268.16.01002 Boehringer Ingelheim Investigational Site

Charleston, South Carolina, United States

Location

1268.16.01005 Boehringer Ingelheim Investigational Site

El Paso, Texas, United States

Location

1268.16.43002 Boehringer Ingelheim Investigational Site

Feldbach, Austria

Location

1268.16.49018 Boehringer Ingelheim Investigational Site

Aschaffenburg, Germany

Location

1268.16.49014 Boehringer Ingelheim Investigational Site

Bamberg, Germany

Location

1268.16.49001 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1268.16.49004 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1268.16.49010 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1268.16.49012 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1268.16.49013 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1268.16.49016 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1268.16.49008 Boehringer Ingelheim Investigational Site

Erfurt, Germany

Location

1268.16.49005 Boehringer Ingelheim Investigational Site

Frankfurt, Germany

Location

1268.16.49015 Boehringer Ingelheim Investigational Site

Frankfurt, Germany

Location

1268.16.49011 Boehringer Ingelheim Investigational Site

Hamburg, Germany

Location

1268.16.49009 Boehringer Ingelheim Investigational Site

Hanover, Germany

Location

1268.16.49017 Boehringer Ingelheim Investigational Site

Hanover, Germany

Location

1268.16.49007 Boehringer Ingelheim Investigational Site

Koblenz, Germany

Location

1268.16.49006 Boehringer Ingelheim Investigational Site

Lübeck, Germany

Location

1268.16.49002 Boehringer Ingelheim Investigational Site

Rüdersdorf, Germany

Location

1268.16.49003 Boehringer Ingelheim Investigational Site

Weinheim, Germany

Location

1268.16.39006 Boehringer Ingelheim Investigational Site

Ferrara, Italy

Location

1268.16.39007 Boehringer Ingelheim Investigational Site

Milan, Italy

Location

1268.16.39004 Boehringer Ingelheim Investigational Site

Pietra Ligure (SV), Italy

Location

1268.16.39001 Boehringer Ingelheim Investigational Site

Pisa, Italy

Location

1268.16.64001 Boehringer Ingelheim Investigational Site

Christchurch NZ, New Zealand

Location

1268.16.64003 Boehringer Ingelheim Investigational Site

Greenlane East Auckland, New Zealand

Location

1268.16.82008 Boehringer Ingelheim Investigational Site

Anyang, South Korea

Location

1268.16.82009 Boehringer Ingelheim Investigational Site

Bucheon-si, South Korea

Location

1268.16.82007 Boehringer Ingelheim Investigational Site

Cheongju-si, South Korea

Location

1268.16.82006 Boehringer Ingelheim Investigational Site

Daegu, South Korea

Location

1268.16.82010 Boehringer Ingelheim Investigational Site

Gwangju, South Korea

Location

1268.16.82001 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1268.16.82002 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1268.16.82004 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1268.16.82005 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1268.16.82003 Boehringer Ingelheim Investigational Site

Suwon, South Korea

Location

1268.16.46002 Boehringer Ingelheim Investigational Site

Gothenburg, Sweden

Location

1268.16.46001 Boehringer Ingelheim Investigational Site

Lund, Sweden

Location

1268.16.46003 Boehringer Ingelheim Investigational Site

Örebro, Sweden

Location

1268.16.90002 Boehringer Ingelheim Investigational Site

Bursa, Turkey (Türkiye)

Location

1268.16.90003 Boehringer Ingelheim Investigational Site

Istanbul, Turkey (Türkiye)

Location

1268.16.90004 Boehringer Ingelheim Investigational Site

Istanbul, Turkey (Türkiye)

Location

1268.16.90006 Boehringer Ingelheim Investigational Site

Istanbul, Turkey (Türkiye)

Location

1268.16.90001 Boehringer Ingelheim Investigational Site

Mersin, Turkey (Türkiye)

Location

1268.16.44005 Boehringer Ingelheim Investigational Site

Chertsey, United Kingdom

Location

1268.16.44004 Boehringer Ingelheim Investigational Site

London, United Kingdom

Location

1268.16.44002 Boehringer Ingelheim Investigational Site

Manchester, United Kingdom

Location

1268.16.44003 Boehringer Ingelheim Investigational Site

Southampton, United Kingdom

Location

Related Links

• Related Info

MeSH Terms

Conditions

Asthma

Interventions

BI 671800; montelukast

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2010
• First Posted: April 14, 2010
• Study Start: April 20, 2010
• Primary Completion: August 9, 2011
• Study Completion: August 9, 2011
• Last Updated: May 31, 2022
• Results First Posted: May 31, 2022

Record last verified: 2022-05

Locations

TU (5); GB (4); AU (1); IT (4); DE (18); NZ (2); KR (10); SE (3); US (6)