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NCT Number: NCT01103349

BI 671800 in Asthmatic Patients on Inhaled Corticosteroids

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

1268.16.43002 Boehringer Ingelheim Investigational Site, Feldbach, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BI 671800

Drug

Double blind randomised parallel group study to assess efficacy and tolerability of BI 617800 in patients with symptomatic asthma

Placebo

Drug

Patients receive placebo capsules and/or encapsulated tablets

Montelukast

Drug

Double blind randomised parallel group study to assess efficacy and tolerability of BI 671800 in patients with symptomatic asthma

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

    Time frame: Measurements at baseline (mean observed in the 2 weeks prior to treatment) and at week 6 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.

Secondary outcomes

  1. Asthma Control Questionnaire (ACQ) Mean Change in Score on a Scale From Baseline After Six Weeks of Treatment

    Time frame: Measurements at baseline (mean ACQ score obtained at Week 0) and at week 6 of treatment.

    Asthma Control Questionnaire (ACQ) mean score change from baseline (mean ACQ score obtained at Week 0) after six weeks of treatment.

    The Asthma Control Questionnaire (ACQ) is a patient-reported outcome questionnaire containing 7 items. The items are equally weighted and the ACQ score is the mean of the 7 items and therefore between 0 (well controlled) and 6 (extremely poorly controlled) These questions based on recall of the previous 7 days comprise breathlessness, nocturnal waking, symptoms on waking, activity limitation, wheeze, frequency of Short-acting beta-adrenergic (SABA) use, and categorized pre-bronchodilator FEV1% predicted.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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)

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Apr 14, 2010
Registry last updated
May 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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