BI671800 in Asthmatic Patients on Inhaled Corticosteroids - Full Text View

Purpose

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.

Condition	Intervention	Phase
Asthma	Drug: BI671800 Drug: Placebo Drug: Montelukast	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	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)

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Fluticasone Montelukast sodium Montelukast

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

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 ]

Enrollment:	243
Study Start Date:	March 2010
Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: BI671800 Patients receive BI671800 capsules twice daily	Drug: BI671800 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	Drug: Montelukast 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	Drug: Placebo Patients receive placebo capsules and/or encapsulated tablets

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

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.

Exclusion criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01103349

Show 53 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

No publications provided

Responsible Party:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01103349 History of Changes
Other Study ID Numbers:	1268.16, 2009-014551-80
Study First Received:	March 19, 2010
Last Updated:	December 14, 2011
Health Authority:	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:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Montelukast
Bronchodilator Agents
Autonomic Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on May 19, 2013