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Completed

NCT Number: NCT00557700

Study to Investigate the Effect of Inhaled Tiotropium Bromide on Neurokinin-A Induced Bronchoconstriction in Patients With Mild-to-moderate Asthma

This trial compares the outcome of treatment of mild to moderate asthma: inhaled tiotropium bromide versus placebo.

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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 and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital Ghent, Ghent, Belgium

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Informed consent
  • Male or female, at least 18 years old
  • Documented medical history of asthma (diagnosis at least 6 months ago)
  • Non-smoker or at least stopped for 1 year (in case smoked earlier: maximum of 10 pack-years)
  • Able to conduct a technically acceptable spirometry, methacholine and neurokinin-A provocation test.
  • At visit 1: PC20 methacholine ≤ 8 mg/ml AND ≤ 3.3x10-7 mol/ml for the neurokinin-A provocation test.
  • At visit 1: forced expiratory value in one second >= 80% of the predicted value.
  • Female subjects may not get pregnant and should be using adequate contraception.

Exclusion criteria

  • Airway infection within 6 weeks prior to first study visit.
  • Other respiratory diseases (eg COPD, lung cancer, etc.)
  • Participating in another clinical trial.
  • Clinically relevant systemic diseases, other than asthma.
  • Clinically significant laboratory deviations.
  • Alcohol or drug abuse.
  • Female subjects who are lactating.

Treatment and study plan

Administration of inhaled tiotropium bromide

Drug

Administration of inhaled tiotropium bromide

Administration of placebo

Drug

Administration of placebo

Primary outcomes

  1. The mean change in the provocative concentration of neurokinin-A (NKA) causing a 20% fall in the forced expiratory volume in one second (PC20NKA), as a measure of indirect airway hyperresponsiveness

    Time frame: After 20 days

Secondary outcomes

  1. The change in the one-second-value in the forced vital capacity

    Time frame: After 20 days

  2. The mean change in PC20 of methacholine, as a measure of direct airway hyperresponsiveness

    Time frame: After 20 days

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • Boehringer Ingelheim

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Nov 14, 2007
Registry last updated
Jun 16, 2010

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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