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Bi 671800 in Asthmatic Patients on Inhaled Corticosteroids

NCT ID: NCT01090024

Last Updated: 2022-05-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-01

Study Completion Date

2011-02-18

Brief Summary

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To investigate the effectiveness and safety of BI 671800 given in the morning (AM), evening (PM) or twice daily (b.i.d.) compared too placebo as add on therapy to inhaled corticosteroid in symptomatic asthma patients.

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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

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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BI 671800 AM and PM

Patients receiving two capsules twice daily

Group Type EXPERIMENTAL

BI 671800

Intervention Type DRUG

BI 671800

BI 671800 AM

Patients receiving four capsules in the morning

Group Type EXPERIMENTAL

BI 671800

Intervention Type DRUG

BI 671800

BI 671800 PM

Patients receiving four capsules in the evening

Group Type EXPERIMENTAL

BI 671800

Intervention Type DRUG

BI 671800

Placebo

Patients receiving four capsules twice a day

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo matching BI 671800

Interventions

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BI 671800

BI 671800

Intervention Type DRUG

Placebo

Placebo matching BI 671800

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Signed informed consent consistent with International Conference on Harmonisation (ICH) - Good Clinical Practice (GCP) (ICH-GCP)
2. Three month history of reversible (12% with 200 mL) asthma according to \[Global Initiative for Asthma (GINA)\] with following spirometry at randomization:forced expiratory volume in 1 second (FEV1) 60%-85%.
3. Stable inhaled corticosteroid (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 randomization.
6. Male or female, 18 to 65 years.
7. Non-smokers or ex-smokers ( less than 10 pack year history) with negative cotinine screen.
8. Able to perform pulmonary function test (PFT).

Exclusion Criteria

1. Significant diseases other than asthma or allergic rhinitis.
2. Hepatic transaminases or total bilirubin greater than 1.5 upper limit of normal (ULN).
3. Hospitalizations for asthma or asthma related intubation within 3 months.
4. Uncontrolled asthma on ICS + another controller.
5. Respiratory tract infection or exacerbation within 4 weeks.
6. FEV1 less than 40%, more than 12 puffs of short acting beta agonists (SABA) on more than two consecutive days or asthma exacerbation during the run-in period.
7. Participation in another interventional study.
8. Pregnant or nursing women.
9. Women of child bearing potential nor using appropriate methods of birth control as defined by 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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1268.53.01013 Boehringer Ingelheim Investigational Site

Huntington Beach, California, United States

Site Status

1268.53.01014 Boehringer Ingelheim Investigational Site

Mission Viejo, California, United States

Site Status

1268.53.01002 Boehringer Ingelheim Investigational Site

Stockton, California, United States

Site Status

1268.53.01009 Boehringer Ingelheim Investigational Site

Colorado Springs, Colorado, United States

Site Status

1268.53.01011 Boehringer Ingelheim Investigational Site

Denver, Colorado, United States

Site Status

1268.53.01001 Boehringer Ingelheim Investigational Site

North Dartmouth, Massachusetts, United States

Site Status

1268.53.01005 Boehringer Ingelheim Investigational Site

Minneapolis, Minnesota, United States

Site Status

1268.53.01006 Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

Site Status

1268.53.01007 Boehringer Ingelheim Investigational Site

Raleigh, North Carolina, United States

Site Status

1268.53.01010 Boehringer Ingelheim Investigational Site

Portland, Oregon, United States

Site Status

1268.53.01003 Boehringer Ingelheim Investigational Site

Charleston, South Carolina, United States

Site Status

1268.53.01008 Boehringer Ingelheim Investigational Site

El Paso, Texas, United States

Site Status

1268.53.01012 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Site Status

1268.53.01015 Boehringer Ingelheim Investigational Site

Richmond, Virginia, United States

Site Status

Countries

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United States

Related Links

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http://www.mystudywindow.com/

Related Info

Other Identifiers

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1268.53

Identifier Type: -

Identifier Source: org_study_id

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