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Completed

NCT Number: NCT01092143

BI 671800 ED in Steroid-naive Asthmatic Patients

This is a 6 week study to investigate the effectiveness and safety of BI 671800 ED in patients with asthma who do not take inhaled corticosteroids.

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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

1268.17.61001 Boehringer Ingelheim Investigational Site, Adelaide, South Australia, Australia

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% with 200 mL) asthma (according to GINA) with following spirometry at randomization: FEV1 60%-85%.
  • No ICS previous 3 months prior to screening.
  • Diagnosis of asthma prior to 40 years.
  • 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 PFT

Exclusion criteria

  • Significant diseases other than asthma or allergic rhinitis.
  • Hepatic transaminases or total bilirubin greater than 1.5 ULN.
  • Hospitalizations for asthma or asthma related intubation within 3 months.
  • Uncontrolled asthma.
  • Respiratory tract infection or exacerbation within 4 weeks.
  • FEV1 less than 40%, more than 12 puffs of 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

Fluticasone propionate placebo

Drug

Placebo matching Fluticasone propionate

Fluticasone propionate

Drug

Fluticasone propionate

BI 671800 Placebo

Drug

Placebo matching BI 671800

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 Score Change 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

A Randomized, Double Blind, Placebo and Active Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of 6-week Treatment With Oral Doses of 50 mg b.i.d., 200 mg b.i.d., and 400 mg b.i.d. BI 671800 ED in Steroid-naïve Patients With Persistent Asthma

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 24, 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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