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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01092143




Registration number
NCT01092143
Ethics application status
Date submitted
19/03/2010
Date registered
24/03/2010
Date last updated
16/05/2014

Titles & IDs
Public title
BI 671800 ED in Steroid-naive Asthmatic Patients
Scientific title
A Randomized, Double Blind, Placebo and Active Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of 6-week Treatment With Oral Doses of 50 mg b.i.d., 200 mg b.i.d., and 400 mg b.i.d. BI 671800 ED in Steroid-naïve Patients With Persistent Asthma
Secondary ID [1] 0 0
1268.17
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BI671800
Treatment: Drugs - BI671800
Treatment: Drugs - BI 671800
Treatment: Drugs - Fluticasone placebo
Treatment: Drugs - Fluticasone placebo
Treatment: Drugs - Fluticasone placebo
Treatment: Drugs - Fluticasone placebo
Treatment: Drugs - Fluticasone
Treatment: Drugs - BI 671800 Placebo
Treatment: Drugs - BI 671800 Placebo

Experimental: BI671800 (low dose) - Patients receive BI671800 (low dose) capsules twice daily

Active Comparator: Fluticasone - Patients inhale from Fluticasone MDI twice daily

Placebo Comparator: placebo - Patients receive placebo capsules twice daily

Experimental: BI671800 (medium dose) - Patients receive BI671800 (medium dose) capsules twice daily

Experimental: BI671800 (high dose) - Patients receive BI671800 (high dose) capsules twice daily


Treatment: Drugs: BI671800
double blind randomized parallel group study

Treatment: Drugs: BI671800
double blind randomized parallel group study

Treatment: Drugs: BI 671800
double blind randomized parallel

Treatment: Drugs: Fluticasone placebo
double blind randomized parallel

Treatment: Drugs: Fluticasone placebo
double blind randomized parallel

Treatment: Drugs: Fluticasone placebo
double blind randomized parallel

Treatment: Drugs: Fluticasone placebo
double blind randomized parallel

Treatment: Drugs: Fluticasone
double blind randomized parallel

Treatment: Drugs: BI 671800 Placebo
double blind randomized parallel

Treatment: Drugs: BI 671800 Placebo
double blind randomized parallel

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Forced expiratory volume in one second (FEV1) % predicted trough change from baseline after six weeks of treatment.
Timepoint [1] 0 0
6 weeks
Secondary outcome [1] 0 0
Asthma Control Questionnaire (ACQ) total score change from baseline after six weeks of treatment
Timepoint [1] 0 0
6 weeks

Eligibility
Key inclusion criteria
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
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
1268.17.61001 Boehringer Ingelheim Investigational Site - Adelaide
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
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California
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United States of America
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Colorado
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Florida
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United States of America
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Illinois
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Indiana
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Iowa
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United States of America
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Missouri
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Montana
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Nebraska
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North Carolina
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Ohio
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Oklahoma
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United States of America
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Pennsylvania
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South Carolina
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United States of America
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Texas
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United States of America
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Washington
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Canada
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Ontario
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Canada
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Quebec
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Colombia
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Bogotá
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Colombia
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Medellín
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Korea, Republic of
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Cheongju
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Korea, Republic of
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Seoul
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Korea, Republic of
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Suwon
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Korea, Republic of
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Wonju
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Mexico
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Cuernavaca
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Mexico
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Monterrey
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Mexico
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Toriello Guerra
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Mexico
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Zona Río
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New Zealand
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Christchurch
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New Zealand
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Greenlane East Auckland
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New Zealand
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Newtown Wellington NZ
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Peru
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Jesús María
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Peru
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Lima
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Peru
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San Borja
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Peru
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San Isidro.
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Peru
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Santiago de Surco
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Peru
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Urb. Ingeniería
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Philippines
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Caloocan City
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Philippines
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Manila
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Philippines
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Quezon City
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Taiwan
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Chiayi City
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Taiwan
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Kaohsiung City
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Taiwan
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Taichung
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Taiwan
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Taipei
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Taiwan
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Taoyuan County

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT01092143
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim
Address 0 0
Boehringer Ingelheim
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications