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BI671800 in Asthmatic Patients on Inhaled Corticosteroids

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01103349
Recruitment Status : Completed
First Posted : April 14, 2010
Last Update Posted : May 16, 2014
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
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 or disease Intervention/treatment Phase
Asthma Drug: BI671800 Drug: Placebo Drug: Montelukast Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 243 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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)
Study Start Date : March 2010
Actual Primary Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Montelukast

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. FEV1 %(Forced Expiratory Volume in 1 second) predicted trough change from baseline after 6 weeks of treatment [ Time Frame: Baseline and 6 weeks ]

Secondary Outcome Measures :
  1. Asthma Control Quality (ACQ) total score change from baseline after 6 weeks of treatment. [ Time Frame: Baseline and 6 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  1. Signed informed consent consistent with ICH-GCP
  2. 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%.
  3. Stable inhaled corticosteroids (iCS) dose 3 months prior to screening.
  4. Diagnosis of asthma prior to 40 years.
  5. Asthma Control Questionnaire (ACQ) at least 1.5 at randomisation.
  6. Male or female 18 to 65 years.
  7. Non-smokers or ex-smokers (less than 10 pack years history) with negative cotinine screen.
  8. Able to perform pulmonary function testing.

Exclusion criteria:

  1. Significant diseases other than asthma or allergic rhinitis.
  2. Hepatic transaminases or total bilirubin greater than 1.5 ULN.
  3. Hospitalisation for asthma exacerbation or asthma related intubation within 3 months.
  4. Uncontrolled asthma on iCS + other controller.
  5. Respiratory tract infection or exacerbation within 4 weeks.
  6. FEV1 less than 40%, more than 12 puffs rescue salbutamol on more than two consecutive days, or asthma exacerbation during run-in period.
  7. Participation in another interventional study.
  8. Pregnant or nursing women.
  9. Women of child bearing potential not using appropriate methods of birth control as defined by the study protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01103349

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Sponsors and Collaborators
Boehringer Ingelheim
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim

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Responsible Party: Boehringer Ingelheim Identifier: NCT01103349     History of Changes
Other Study ID Numbers: 1268.16
2009-014551-80 ( EudraCT Number: EudraCT )
First Posted: April 14, 2010    Key Record Dates
Last Update Posted: May 16, 2014
Last Verified: December 2011

Additional relevant MeSH terms:
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Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action