BI671800 in Asthmatic Patients on Inhaled Corticosteroids
This study has been completed.
Information provided by (Responsible Party):
First received: March 19, 2010
Last updated: April 30, 2014
Last verified: December 2011
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.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
||Randomised, Double Blind, Double Dummy, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of 6 Weeks of Oral BI 671800 ED Twice Daily (b.i.d.), Montelukast Once Daily (q.d.) or Placebo in Symptomatic Asthmatic Patients on Low Dose Fluticasone Propionate MDI (Metered Dose Inhaler)
Primary Outcome Measures:
- FEV1 %(Forced Expiratory Volume in 1 second) predicted trough change from baseline after 6 weeks of treatment [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Asthma Control Quality (ACQ) total score change from baseline after 6 weeks of treatment. [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
| Study Start Date:
| Primary Completion Date:
||August 2011 (Final data collection date for primary outcome measure)
Patients receive BI671800 capsules twice daily
Double blind randomised parallel group study to assess efficacy and tolerability of BI617800 in patients with symptomatic asthma
Active Comparator: Montelukast
Patients receive Montelukast encapsulated tablets once daily
Double blind randomised parallel group study to assess efficacy and tolerability of BI671800 in patients with symptomatic asthma
Placebo Comparator: Placebo
Patients receive placebo capsules and/or encapsulated placebo tablets
Patients receive placebo capsules and/or encapsulated tablets
|Ages Eligible for Study:
||18 Years to 65 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Signed informed consent consistent with ICH-GCP
- 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%.
- Stable inhaled corticosteroids (iCS) dose 3 months prior to screening.
- Diagnosis of asthma prior to 40 years.
- Asthma Control Questionnaire (ACQ) at least 1.5 at randomisation.
- Male or female 18 to 65 years.
- Non-smokers or ex-smokers (less than 10 pack years history) with negative cotinine screen.
- Able to perform pulmonary function testing.
- Significant diseases other than asthma or allergic rhinitis.
- Hepatic transaminases or total bilirubin greater than 1.5 ULN.
- Hospitalisation for asthma exacerbation or asthma related intubation within 3 months.
- Uncontrolled asthma on iCS + other controller.
- Respiratory tract infection or exacerbation within 4 weeks.
- FEV1 less than 40%, more than 12 puffs rescue salbutamol on more than two consecutive days, or asthma exacerbation during run-in period.
- Participation in another interventional study.
- Pregnant or nursing women.
- Women of child bearing potential not using appropriate methods of birth control as defined by the study protocol.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01103349
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 19, 2010
||April 30, 2014
||Austria: Federal Office for Safety in Health Care
Germany: Federal Institute for Drugs and Medical Devices
Italy: Ethics Committee
New Zealand: Multi-Regional Ethics Committee
South Korea: Korea Food and Drug Administration (KFDA)
Sweden: Medical Products Agency
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 31, 2014
Respiratory Tract Diseases
Lung Diseases, Obstructive
Immune System Diseases
Peripheral Nervous System Agents
Physiological Effects of Drugs
Respiratory System Agents
Hormones, Hormone Substitutes, and Hormone Antagonists