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BI 671800 ED in Steroid-naive Asthmatic Patients

NCT ID: NCT01092143

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

389 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-18

Study Completion Date

2011-03-26

Brief Summary

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This is a 6 week study to investigate the effectiveness and safety of BI 671800 ED in patients with asthma who do not take inhaled corticosteroids.

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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 (low dose)

Patients receive BI 671800 (low dose) capsules twice daily

Group Type EXPERIMENTAL

BI 671800

Intervention Type DRUG

BI 671800

Fluticasone propionate placebo

Intervention Type DRUG

Placebo matching Fluticasone propionate

Fluticasone propionate

Patients inhale from Fluticasone propionate metered dose inhaler (MDI) twice daily

Group Type ACTIVE_COMPARATOR

Fluticasone propionate

Intervention Type DRUG

Fluticasone propionate

BI 671800 Placebo

Intervention Type DRUG

Placebo matching BI 671800

Placebo

Patients receive placebo capsules twice daily

Group Type PLACEBO_COMPARATOR

Fluticasone propionate placebo

Intervention Type DRUG

Placebo matching Fluticasone propionate

BI 671800 Placebo

Intervention Type DRUG

Placebo matching BI 671800

BI 671800 (medium dose)

Patients receive BI 671800 (medium dose) capsules twice daily

Group Type EXPERIMENTAL

BI 671800

Intervention Type DRUG

BI 671800

Fluticasone propionate placebo

Intervention Type DRUG

Placebo matching Fluticasone propionate

BI 671800 (high dose)

Patients receive BI 671800 (high dose) capsules twice daily

Group Type EXPERIMENTAL

BI 671800

Intervention Type DRUG

BI 671800

Fluticasone propionate placebo

Intervention Type DRUG

Placebo matching Fluticasone propionate

Interventions

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BI 671800

BI 671800

Intervention Type DRUG

Fluticasone propionate placebo

Placebo matching Fluticasone propionate

Intervention Type DRUG

Fluticasone propionate

Fluticasone propionate

Intervention Type DRUG

BI 671800 Placebo

Placebo matching BI 671800

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% with 200 mL) asthma (according to GINA) with following spirometry at randomization: FEV1 60%-85%.
3. No ICS previous 3 months prior to screening.
4. Diagnosis of asthma prior to 40 years.
5. 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 PFT

Exclusion Criteria

1. Significant diseases other than asthma or allergic rhinitis.
2. Hepatic transaminases or total bilirubin greater than 1.5 ULN.
3. Hospitalizations for asthma or asthma related intubation within 3 months.
4. Uncontrolled asthma.
5. Respiratory tract infection or exacerbation within 4 weeks.
6. FEV1 less than 40%, more than 12 puffs of 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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1268.17.01043 Boehringer Ingelheim Investigational Site

Tucson, Arizona, United States

Site Status

1268.17.01009 Boehringer Ingelheim Investigational Site

Cypress, California, United States

Site Status

1268.17.01006 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Site Status

1268.17.01040 Boehringer Ingelheim Investigational Site

Palmdale, California, United States

Site Status

1268.17.01024 Boehringer Ingelheim Investigational Site

San Jose, California, United States

Site Status

1268.17.01003 Boehringer Ingelheim Investigational Site

Stockton, California, United States

Site Status

1268.17.01015 Boehringer Ingelheim Investigational Site

Colorado Springs, Colorado, United States

Site Status

1268.17.01001 Boehringer Ingelheim Investigational Site

Denver, Colorado, United States

Site Status

1268.17.01016 Boehringer Ingelheim Investigational Site

Lakewood, Colorado, United States

Site Status

1268.17.01033 Boehringer Ingelheim Investigational Site

Wheat Ridge, Colorado, United States

Site Status

1268.17.01045 Boehringer Ingelheim Investigational Site

DeLand, Florida, United States

Site Status

1268.17.01036 Boehringer Ingelheim Investigational Site

Normal, Illinois, United States

Site Status

1268.17.01025 Boehringer Ingelheim Investigational Site

South Bend, Indiana, United States

Site Status

1268.17.01005 Boehringer Ingelheim Investigational Site

Iowa City, Iowa, United States

Site Status

1268.17.01034 Boehringer Ingelheim Investigational Site

Baltimore, Maryland, United States

Site Status

1268.17.01014 Boehringer Ingelheim Investigational Site

North Dartmouth, Massachusetts, United States

Site Status

1268.17.01030 Boehringer Ingelheim Investigational Site

North Dartmouth, Massachusetts, United States

Site Status

1268.17.01027 Boehringer Ingelheim Investigational Site

Novi, Michigan, United States

Site Status

1268.17.01032 Boehringer Ingelheim Investigational Site

Minneapolis, Minnesota, United States

Site Status

1268.17.01010 Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

Site Status

1268.17.01037 Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

Site Status

1268.17.01022 Boehringer Ingelheim Investigational Site

Bozeman, Montana, United States

Site Status

1268.17.01008 Boehringer Ingelheim Investigational Site

Bellevue, Nebraska, United States

Site Status

1268.17.01011 Boehringer Ingelheim Investigational Site

Raleigh, North Carolina, United States

Site Status

1268.17.01004 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

Site Status

1268.17.01038 Boehringer Ingelheim Investigational Site

Oklahoma City, Oklahoma, United States

Site Status

1268.17.01042 Boehringer Ingelheim Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

1268.17.01007 Boehringer Ingelheim Investigational Site

Charleston, South Carolina, United States

Site Status

1268.17.01031 Boehringer Ingelheim Investigational Site

Easley, South Carolina, United States

Site Status

1268.17.01039 Boehringer Ingelheim Investigational Site

Fort Mill, South Carolina, United States

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1268.17.01026 Boehringer Ingelheim Investigational Site

Greenville, South Carolina, United States

Site Status

1268.17.01029 Boehringer Ingelheim Investigational Site

Greenville, South Carolina, United States

Site Status

1268.17.01049 Boehringer Ingelheim Investigational Site

Spartanburg, South Carolina, United States

Site Status

1268.17.01019 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

Site Status

1268.17.01012 Boehringer Ingelheim Investigational Site

El Paso, Texas, United States

Site Status

1268.17.01023 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Site Status

1268.17.01048 Boehringer Ingelheim Investigational Site

Killeen, Texas, United States

Site Status

1268.17.01028 Boehringer Ingelheim Investigational Site

New Braunfels, Texas, United States

Site Status

1268.17.01035 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Site Status

1268.17.01047 Boehringer Ingelheim Investigational Site

Tacoma, Washington, United States

Site Status

1268.17.61001 Boehringer Ingelheim Investigational Site

Adelaide, South Australia, Australia

Site Status

1268.17.02015 Boehringer Ingelheim Investigational Site

Greater Sudbury, Ontario, Canada

Site Status

1268.17.02012 Boehringer Ingelheim Investigational Site

Hawkesbury, Ontario, Canada

Site Status

1268.17.02010 Boehringer Ingelheim Investigational Site

Mississauga, Ontario, Canada

Site Status

1268.17.02014 Boehringer Ingelheim Investigational Site

Newmarket, Ontario, Canada

Site Status

1268.17.02003 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Site Status

1268.17.02013 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Site Status

1268.17.02001 Boehringer Ingelheim Investigational Site

Québec, Quebec, Canada

Site Status

1268.17.02004 Boehringer Ingelheim Investigational Site

Québec, Quebec, Canada

Site Status

1268.17.57003 Boehringer Ingelheim Investigational Site

Bogotá, , Colombia

Site Status

1268.17.57004 Boehringer Ingelheim Investigational Site

Bogotá, , Colombia

Site Status

1268.17.57002 Boehringer Ingelheim Investigational Site

Medellín, , Colombia

Site Status

1268.17.52002 Boehringer Ingelheim Investigational Site

Cuernavaca, , Mexico

Site Status

1268.17.52001 Boehringer Ingelheim Investigational Site

Monterrey, , Mexico

Site Status

1268.17.52004 Boehringer Ingelheim Investigational Site

Toriello Guerra, , Mexico

Site Status

1268.17.52003 Boehringer Ingelheim Investigational Site

Zona Río, , Mexico

Site Status

1268.17.64001 Boehringer Ingelheim Investigational Site

Christchurch, , New Zealand

Site Status

1268.17.64003 Boehringer Ingelheim Investigational Site

Greenlane East Auckland, , New Zealand

Site Status

1268.17.64002 Boehringer Ingelheim Investigational Site

Newtown Wellington NZ, , New Zealand

Site Status

1268.17.51003 Boehringer Ingelheim Investigational Site

Jesús María, , Peru

Site Status

1268.17.51002 Boehringer Ingelheim Investigational Site

Lima, , Peru

Site Status

1268.17.51006 Boehringer Ingelheim Investigational Site

San Borja, , Peru

Site Status

1268.17.51004 Boehringer Ingelheim Investigational Site

San Isidro, , Peru

Site Status

1268.17.51005 Boehringer Ingelheim Investigational Site

Santiago de Surco, , Peru

Site Status

1268.17.51001 Boehringer Ingelheim Investigational Site

Urb. Ingeniería, , Peru

Site Status

1268.17.63007 Boehringer Ingelheim Investigational Site

Caloocan City, , Philippines

Site Status

1268.17.63002 Boehringer Ingelheim Investigational Site

Manila, , Philippines

Site Status

1268.17.63001 Boehringer Ingelheim Investigational Site

Quezon City, , Philippines

Site Status

1268.17.63003 Boehringer Ingelheim Investigational Site

Quezon City, , Philippines

Site Status

1268.17.63004 Boehringer Ingelheim Investigational Site

Quezon City, , Philippines

Site Status

1268.17.63005 Boehringer Ingelheim Investigational Site

Quezon City, , Philippines

Site Status

1268.17.63006 Boehringer Ingelheim Investigational Site

Quezon City, , Philippines

Site Status

1268.17.82007 Boehringer Ingelheim Investigational Site

Cheongju-si, , South Korea

Site Status

1268.17.82001 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1268.17.82002 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1268.17.82004 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1268.17.82005 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1268.17.82006 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1268.17.82003 Boehringer Ingelheim Investigational Site

Suwon, , South Korea

Site Status

1268.17.82008 Boehringer Ingelheim Investigational Site

Wŏnju, , South Korea

Site Status

1268.17.86210 Boehringer Ingelheim Investigational Site

Chiayi City, , Taiwan

Site Status

1268.17.86211 Boehringer Ingelheim Investigational Site

Kaohsiung City, , Taiwan

Site Status

1268.17.86207 Boehringer Ingelheim Investigational Site

Taichung, , Taiwan

Site Status

1268.17.86208 Boehringer Ingelheim Investigational Site

Taichung, , Taiwan

Site Status

1268.17.86209 Boehringer Ingelheim Investigational Site

Taichung, , Taiwan

Site Status

1268.17.86201 Boehringer Ingelheim Investigational Site

Taipei, , Taiwan

Site Status

1268.17.86202 Boehringer Ingelheim Investigational Site

Taipei, , Taiwan

Site Status

1268.17.86203 Boehringer Ingelheim Investigational Site

Taipei, , Taiwan

Site Status

1268.17.86204 Boehringer Ingelheim Investigational Site

Taipei, , Taiwan

Site Status

1268.17.86205 Boehringer Ingelheim Investigational Site

Taipei, , Taiwan

Site Status

1268.17.86206 Boehringer Ingelheim Investigational Site

Taipei, , Taiwan

Site Status

1268.17.86200 Boehringer Ingelheim Investigational Site

Taoyuan, , Taiwan

Site Status

Countries

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United States Australia Canada Colombia Mexico New Zealand Peru Philippines South Korea Taiwan

Related Links

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http://www.mystudywindow.com/

Related Info

Other Identifiers

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1268.17

Identifier Type: -

Identifier Source: org_study_id

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