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Completed

NCT Number: NCT01090024

Bi 671800 in Asthmatic Patients on Inhaled Corticosteroids

To investigate the effectiveness and safety of BI 671800 given in the morning (AM), evening (PM) or twice daily (b.i.d.) compared too placebo as add on therapy to inhaled corticosteroid in symptomatic asthma patients.

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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

1268.53.01013 Boehringer Ingelheim Investigational Site, Huntington Beach, California, United States

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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 International Conference on Harmonisation (ICH) - Good Clinical Practice (GCP) (ICH-GCP)
  • Three month history of reversible (12% with 200 mL) asthma according to [Global Initiative for Asthma (GINA)] with following spirometry at randomization:forced expiratory volume in 1 second (FEV1) 60%-85%.
  • Stable inhaled corticosteroid (ICS) dose 3 months prior to screening.
  • Diagnosis of asthma prior to 40 years.
  • Asthma Control Questionnaire (ACQ) at least 1.5 at randomization.
  • Male or female, 18 to 65 years.
  • Non-smokers or ex-smokers ( less than 10 pack year history) with negative cotinine screen.
  • Able to perform pulmonary function test (PFT).

Exclusion criteria

  • Significant diseases other than asthma or allergic rhinitis.
  • Hepatic transaminases or total bilirubin greater than 1.5 upper limit of normal (ULN).
  • Hospitalizations for asthma or asthma related intubation within 3 months.
  • Uncontrolled asthma on ICS + another controller.
  • Respiratory tract infection or exacerbation within 4 weeks.
  • FEV1 less than 40%, more than 12 puffs of short acting beta agonists (SABA) on more than two consecutive days or asthma exacerbation during the run-in period.
  • Participation in another interventional study.
  • Pregnant or nursing women.
  • Women of child bearing potential nor using appropriate methods of birth control as defined by protocol.

Treatment and study plan

BI 671800

Drug

BI 671800

Placebo

Drug

Placebo matching BI 671800

Primary outcomes

  1. Change From Baseline of Trough Forced Expiratory Volume in One Second (FEV1) Percent Predicted After 4 Weeks of Treatment

    Time frame: At baseline and 4 weeks

    Trough FEV1 percent (%) predicted was defined as the mean of the morning and the evening FEV1 % predicted daily trough value at the end of the dosing interval. For the morning (evening) measurements, when FEV1 % predicted was available at both 25 minutes and 10 minutes prior to morning (evening) test-drug inhalation, morning (evening) trough FEV1 % predicted was the mean of these two morning (evening) pre-inhalation measurements. Trough FEV1 % predicted change from baseline after 4 weeks of treatment was defined as the change from baseline in the mean of the morning and the evening trough FEV1 % predicted.

Secondary outcomes

  1. Change From Baseline in Asthma Control Questionnaire (ACQ) Mean Score After Four Weeks of Treatment

    Time frame: At baseline and 4 weeks

    The Asthma Control Questionnaire (ACQ) consists of 6 patient self-evaluated questions and 1 by clinical staff with each question in 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of less than or equal to 0.75 indicate well-controlled asthma, scores between 0.76 and less than 1.5 indicate partly controlled asthma, and a score greater than or equal to 1.5 indicates uncontrolled asthma.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

A Randomised, Double-blind, Placebo-controlled, Efficacy and Safety Cross-over Study of 4 Weeks of Oral BI 671800 ED 200 mg Twice Daily or 400 mg Once Daily Administered in the Morning (AM) or Evening (PM), in Symptomatic Asthma Patients on Inhaled Fluticasone Propionate MDI

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 19, 2010
Registry last updated
May 11, 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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