BI 671800 ED in Steroid-naive Asthmatic Patients

NCT01092143 | Completed Phase 2 Results

• 1 other identifier: 1268.17
• Study Type: interventional
• Target: 389
• Locations: 10 countries
• Sites: 92

Brief Summary

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.

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 Score Change 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 (5)

BI 671800 (low dose)

EXPERIMENTAL

Patients receive BI 671800 (low dose) capsules twice daily

Drug: BI 671800; Drug: Fluticasone propionate placebo

Fluticasone propionate

ACTIVE COMPARATOR

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

Drug: Fluticasone propionate; Drug: BI 671800 Placebo

Placebo

PLACEBO COMPARATOR

Patients receive placebo capsules twice daily

Drug: Fluticasone propionate placebo; Drug: BI 671800 Placebo

BI 671800 (medium dose)

EXPERIMENTAL

Patients receive BI 671800 (medium dose) capsules twice daily

Drug: BI 671800; Drug: Fluticasone propionate placebo

BI 671800 (high dose)

EXPERIMENTAL

Patients receive BI 671800 (high dose) capsules twice daily

Drug: BI 671800; Drug: Fluticasone propionate placebo

Interventions

BI 671800 DRUG

BI 671800

BI 671800 (high dose); BI 671800 (low dose); BI 671800 (medium dose)

Fluticasone propionate placebo DRUG

Placebo matching Fluticasone propionate

BI 671800 (high dose); BI 671800 (low dose); BI 671800 (medium dose); Placebo

Fluticasone propionate DRUG

Fluticasone propionate

Fluticasone propionate

BI 671800 Placebo DRUG

Placebo matching BI 671800

Fluticasone propionate; Placebo

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% with 200 mL) asthma (according to GINA) with following spirometry at randomization: FEV1 60%-85%.
• No ICS previous 3 months prior to screening.
• Diagnosis of asthma prior to 40 years.
• ACQ at least 1.5 at randomization.
• Male or female, 18 to 65 years.
• Non-smokers or ex-smokers ( less than 10 pack year history) with negative cotinine screen.
• Able to perform PFT

You may not qualify if:

• Significant diseases other than asthma or allergic rhinitis.
• Hepatic transaminases or total bilirubin greater than 1.5 ULN.
• Hospitalizations for asthma or asthma related intubation within 3 months.
• Uncontrolled asthma.
• Respiratory tract infection or exacerbation within 4 weeks.
• FEV1 less than 40%, more than 12 puffs of SABA on more than two consecutive days or asthma exacerbation during the run-in period.
• Participation in another interventional study.
• Pregnant or nursing women.
• Women of child bearing potential nor using appropriate methods of birth control as defined by protocol

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (92)

1268.17.01043 Boehringer Ingelheim Investigational Site

Tucson, Arizona, United States

Location

1268.17.01009 Boehringer Ingelheim Investigational Site

Cypress, California, United States

Location

1268.17.01006 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Location

1268.17.01040 Boehringer Ingelheim Investigational Site

Palmdale, California, United States

Location

1268.17.01024 Boehringer Ingelheim Investigational Site

San Jose, California, United States

Location

1268.17.01003 Boehringer Ingelheim Investigational Site

Stockton, California, United States

Location

1268.17.01015 Boehringer Ingelheim Investigational Site

Colorado Springs, Colorado, United States

Location

1268.17.01001 Boehringer Ingelheim Investigational Site

Denver, Colorado, United States

Location

1268.17.01016 Boehringer Ingelheim Investigational Site

Lakewood, Colorado, United States

Location

1268.17.01033 Boehringer Ingelheim Investigational Site

Wheat Ridge, Colorado, United States

Location

1268.17.01045 Boehringer Ingelheim Investigational Site

DeLand, Florida, United States

Location

1268.17.01036 Boehringer Ingelheim Investigational Site

Normal, Illinois, United States

Location

1268.17.01025 Boehringer Ingelheim Investigational Site

South Bend, Indiana, United States

Location

1268.17.01005 Boehringer Ingelheim Investigational Site

Iowa City, Iowa, United States

Location

1268.17.01034 Boehringer Ingelheim Investigational Site

Baltimore, Maryland, United States

Location

1268.17.01014 Boehringer Ingelheim Investigational Site

North Dartmouth, Massachusetts, United States

Location

1268.17.01030 Boehringer Ingelheim Investigational Site

North Dartmouth, Massachusetts, United States

Location

1268.17.01027 Boehringer Ingelheim Investigational Site

Novi, Michigan, United States

Location

1268.17.01032 Boehringer Ingelheim Investigational Site

Minneapolis, Minnesota, United States

Location

1268.17.01010 Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

Location

1268.17.01037 Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

Location

1268.17.01022 Boehringer Ingelheim Investigational Site

Bozeman, Montana, United States

Location

1268.17.01008 Boehringer Ingelheim Investigational Site

Bellevue, Nebraska, United States

Location

1268.17.01011 Boehringer Ingelheim Investigational Site

Raleigh, North Carolina, United States

Location

1268.17.01004 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

Location

1268.17.01038 Boehringer Ingelheim Investigational Site

Oklahoma City, Oklahoma, United States

Location

1268.17.01042 Boehringer Ingelheim Investigational Site

Philadelphia, Pennsylvania, United States

Location

1268.17.01007 Boehringer Ingelheim Investigational Site

Charleston, South Carolina, United States

Location

1268.17.01031 Boehringer Ingelheim Investigational Site

Easley, South Carolina, United States

Location

1268.17.01039 Boehringer Ingelheim Investigational Site

Fort Mill, South Carolina, United States

Location

1268.17.01026 Boehringer Ingelheim Investigational Site

Greenville, South Carolina, United States

Location

1268.17.01029 Boehringer Ingelheim Investigational Site

Greenville, South Carolina, United States

Location

1268.17.01049 Boehringer Ingelheim Investigational Site

Spartanburg, South Carolina, United States

Location

1268.17.01019 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

Location

1268.17.01012 Boehringer Ingelheim Investigational Site

El Paso, Texas, United States

Location

1268.17.01023 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Location

1268.17.01048 Boehringer Ingelheim Investigational Site

Killeen, Texas, United States

Location

1268.17.01028 Boehringer Ingelheim Investigational Site

New Braunfels, Texas, United States

Location

1268.17.01035 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Location

1268.17.01047 Boehringer Ingelheim Investigational Site

Tacoma, Washington, United States

Location

1268.17.61001 Boehringer Ingelheim Investigational Site

Adelaide, South Australia, Australia

Location

1268.17.02015 Boehringer Ingelheim Investigational Site

Greater Sudbury, Ontario, Canada

Location

1268.17.02012 Boehringer Ingelheim Investigational Site

Hawkesbury, Ontario, Canada

Location

1268.17.02010 Boehringer Ingelheim Investigational Site

Mississauga, Ontario, Canada

Location

1268.17.02014 Boehringer Ingelheim Investigational Site

Newmarket, Ontario, Canada

Location

1268.17.02003 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Location

1268.17.02013 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Location

1268.17.02001 Boehringer Ingelheim Investigational Site

Québec, Quebec, Canada

Location

1268.17.02004 Boehringer Ingelheim Investigational Site

Québec, Quebec, Canada

Location

1268.17.57003 Boehringer Ingelheim Investigational Site

Bogotá, Colombia

Location

1268.17.57004 Boehringer Ingelheim Investigational Site

Bogotá, Colombia

Location

1268.17.57002 Boehringer Ingelheim Investigational Site

Medellín, Colombia

Location

1268.17.52002 Boehringer Ingelheim Investigational Site

Cuernavaca, Mexico

Location

1268.17.52001 Boehringer Ingelheim Investigational Site

Monterrey, Mexico

Location

1268.17.52004 Boehringer Ingelheim Investigational Site

Toriello Guerra, Mexico

Location

1268.17.52003 Boehringer Ingelheim Investigational Site

Zona Río, Mexico

Location

1268.17.64001 Boehringer Ingelheim Investigational Site

Christchurch, New Zealand

Location

1268.17.64003 Boehringer Ingelheim Investigational Site

Greenlane East Auckland, New Zealand

Location

1268.17.64002 Boehringer Ingelheim Investigational Site

Newtown Wellington NZ, New Zealand

Location

1268.17.51003 Boehringer Ingelheim Investigational Site

Jesús María, Peru

Location

1268.17.51002 Boehringer Ingelheim Investigational Site

Lima, Peru

Location

1268.17.51006 Boehringer Ingelheim Investigational Site

San Borja, Peru

Location

1268.17.51004 Boehringer Ingelheim Investigational Site

San Isidro, Peru

Location

1268.17.51005 Boehringer Ingelheim Investigational Site

Santiago de Surco, Peru

Location

1268.17.51001 Boehringer Ingelheim Investigational Site

Urb. Ingeniería, Peru

Location

1268.17.63007 Boehringer Ingelheim Investigational Site

Caloocan, Philippines

Location

1268.17.63002 Boehringer Ingelheim Investigational Site

Manila, Philippines

Location

1268.17.63001 Boehringer Ingelheim Investigational Site

Quezon City, Philippines

Location

1268.17.63003 Boehringer Ingelheim Investigational Site

Quezon City, Philippines

Location

1268.17.63004 Boehringer Ingelheim Investigational Site

Quezon City, Philippines

Location

1268.17.63005 Boehringer Ingelheim Investigational Site

Quezon City, Philippines

Location

1268.17.63006 Boehringer Ingelheim Investigational Site

Quezon City, Philippines

Location

1268.17.82007 Boehringer Ingelheim Investigational Site

Cheongju-si, South Korea

Location

1268.17.82001 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1268.17.82002 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1268.17.82004 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1268.17.82005 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1268.17.82006 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1268.17.82003 Boehringer Ingelheim Investigational Site

Suwon, South Korea

Location

1268.17.82008 Boehringer Ingelheim Investigational Site

Wŏnju, South Korea

Location

1268.17.86210 Boehringer Ingelheim Investigational Site

Chiayi City, Taiwan

Location

1268.17.86211 Boehringer Ingelheim Investigational Site

Kaohsiung City, Taiwan

Location

1268.17.86207 Boehringer Ingelheim Investigational Site

Taichung, Taiwan

Location

1268.17.86208 Boehringer Ingelheim Investigational Site

Taichung, Taiwan

Location

1268.17.86209 Boehringer Ingelheim Investigational Site

Taichung, Taiwan

Location

1268.17.86201 Boehringer Ingelheim Investigational Site

Taipei, Taiwan

Location

1268.17.86202 Boehringer Ingelheim Investigational Site

Taipei, Taiwan

Location

1268.17.86203 Boehringer Ingelheim Investigational Site

Taipei, Taiwan

Location

1268.17.86204 Boehringer Ingelheim Investigational Site

Taipei, Taiwan

Location

1268.17.86205 Boehringer Ingelheim Investigational Site

Taipei, Taiwan

Location

1268.17.86206 Boehringer Ingelheim Investigational Site

Taipei, Taiwan

Location

1268.17.86200 Boehringer Ingelheim Investigational Site

Taoyuan, Taiwan

Location

Related Links

• Related Info

MeSH Terms

Conditions

Asthma

Interventions

BI 671800; Fluticasone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

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: March 24, 2010
• Study Start: March 18, 2010
• Primary Completion: March 26, 2011
• Study Completion: March 26, 2011
• Last Updated: May 31, 2022
• Results First Posted: May 31, 2022

Record last verified: 2022-05

Locations

KR (8); PH (7); CA (8); US (40); AU (1); PE (6); TW (12); ME (4); NZ (3); CO (3)