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BI 671800 in Asthmatic Patients on Inhaled Corticosteroids

NCT ID: NCT01103349

Last Updated: 2022-05-31

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

243 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-20

Study Completion Date

2011-08-09

Brief Summary

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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.

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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BI 671800

Patients receive BI 671800 capsules twice daily

Group Type EXPERIMENTAL

BI 671800

Intervention Type DRUG

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

Montelukast

Patients receive Montelukast encapsulated tablets once daily

Group Type ACTIVE_COMPARATOR

Montelukast

Intervention Type DRUG

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

Placebo

Patients receive placebo capsules and/or encapsulated placebo tablets

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Patients receive placebo capsules and/or encapsulated tablets

Interventions

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BI 671800

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

Intervention Type DRUG

Placebo

Patients receive placebo capsules and/or encapsulated tablets

Intervention Type DRUG

Montelukast

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1268.16.01004 Boehringer Ingelheim Investigational Site

Denver, Colorado, United States

Site Status

1268.16.01001 Boehringer Ingelheim Investigational Site

North Dartmouth, Massachusetts, United States

Site Status

1268.16.01006 Boehringer Ingelheim Investigational Site

Plymouth, Minnesota, United States

Site Status

1268.16.01003 Boehringer Ingelheim Investigational Site

Portland, Oregon, United States

Site Status

1268.16.01002 Boehringer Ingelheim Investigational Site

Charleston, South Carolina, United States

Site Status

1268.16.01005 Boehringer Ingelheim Investigational Site

El Paso, Texas, United States

Site Status

1268.16.43002 Boehringer Ingelheim Investigational Site

Feldbach, , Austria

Site Status

1268.16.49018 Boehringer Ingelheim Investigational Site

Aschaffenburg, , Germany

Site Status

1268.16.49014 Boehringer Ingelheim Investigational Site

Bamberg, , Germany

Site Status

1268.16.49001 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1268.16.49004 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1268.16.49010 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1268.16.49012 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1268.16.49013 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1268.16.49016 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1268.16.49008 Boehringer Ingelheim Investigational Site

Erfurt, , Germany

Site Status

1268.16.49005 Boehringer Ingelheim Investigational Site

Frankfurt, , Germany

Site Status

1268.16.49015 Boehringer Ingelheim Investigational Site

Frankfurt, , Germany

Site Status

1268.16.49011 Boehringer Ingelheim Investigational Site

Hamburg, , Germany

Site Status

1268.16.49009 Boehringer Ingelheim Investigational Site

Hanover, , Germany

Site Status

1268.16.49017 Boehringer Ingelheim Investigational Site

Hanover, , Germany

Site Status

1268.16.49007 Boehringer Ingelheim Investigational Site

Koblenz, , Germany

Site Status

1268.16.49006 Boehringer Ingelheim Investigational Site

Lübeck, , Germany

Site Status

1268.16.49002 Boehringer Ingelheim Investigational Site

Rüdersdorf, , Germany

Site Status

1268.16.49003 Boehringer Ingelheim Investigational Site

Weinheim, , Germany

Site Status

1268.16.39006 Boehringer Ingelheim Investigational Site

Ferrara, , Italy

Site Status

1268.16.39007 Boehringer Ingelheim Investigational Site

Milan, , Italy

Site Status

1268.16.39004 Boehringer Ingelheim Investigational Site

Pietra Ligure (SV), , Italy

Site Status

1268.16.39001 Boehringer Ingelheim Investigational Site

Pisa, , Italy

Site Status

1268.16.64001 Boehringer Ingelheim Investigational Site

Christchurch NZ, , New Zealand

Site Status

1268.16.64003 Boehringer Ingelheim Investigational Site

Greenlane East Auckland, , New Zealand

Site Status

1268.16.82008 Boehringer Ingelheim Investigational Site

Anyang, , South Korea

Site Status

1268.16.82009 Boehringer Ingelheim Investigational Site

Bucheon-si, , South Korea

Site Status

1268.16.82007 Boehringer Ingelheim Investigational Site

Cheongju-si, , South Korea

Site Status

1268.16.82006 Boehringer Ingelheim Investigational Site

Daegu, , South Korea

Site Status

1268.16.82010 Boehringer Ingelheim Investigational Site

Gwangju, , South Korea

Site Status

1268.16.82001 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1268.16.82002 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1268.16.82004 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1268.16.82005 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1268.16.82003 Boehringer Ingelheim Investigational Site

Suwon, , South Korea

Site Status

1268.16.46002 Boehringer Ingelheim Investigational Site

Gothenburg, , Sweden

Site Status

1268.16.46001 Boehringer Ingelheim Investigational Site

Lund, , Sweden

Site Status

1268.16.46003 Boehringer Ingelheim Investigational Site

Örebro, , Sweden

Site Status

1268.16.90002 Boehringer Ingelheim Investigational Site

Bursa, , Turkey (Türkiye)

Site Status

1268.16.90003 Boehringer Ingelheim Investigational Site

Istanbul, , Turkey (Türkiye)

Site Status

1268.16.90004 Boehringer Ingelheim Investigational Site

Istanbul, , Turkey (Türkiye)

Site Status

1268.16.90006 Boehringer Ingelheim Investigational Site

Istanbul, , Turkey (Türkiye)

Site Status

1268.16.90001 Boehringer Ingelheim Investigational Site

Mersin, , Turkey (Türkiye)

Site Status

1268.16.44005 Boehringer Ingelheim Investigational Site

Chertsey, , United Kingdom

Site Status

1268.16.44004 Boehringer Ingelheim Investigational Site

London, , United Kingdom

Site Status

1268.16.44002 Boehringer Ingelheim Investigational Site

Manchester, , United Kingdom

Site Status

1268.16.44003 Boehringer Ingelheim Investigational Site

Southampton, , United Kingdom

Site Status

Countries

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United States Austria Germany Italy New Zealand South Korea Sweden Turkey (Türkiye) United Kingdom

Related Links

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http://www.mystudywindow.com/

Related Info

Other Identifiers

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2009-014551-80

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1268.16

Identifier Type: -

Identifier Source: org_study_id

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