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

Phase 2

Completed

• Conditions: Asthma
• Interventions: Drug: Administration of placebo; Drug: Administration of inhaled tiotropium bromide

• Registration Number: NCT00557700
• Lead Sponsor: University Hospital, Ghent

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-11-12
• Study First Submitted QC: 2007-11-13
• Study First Posted: 2007-11-14
• Study Start: 2008-01
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2010-06
• Last Update Submitted: 2010-06-15
• Last Update Posted: 2010-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	Administration of placebo	Administration of placebo
1	Administration of inhaled tiotropium bromide	Administration of inhaled tiotropium bromide

Primary Outcome Measures

Name	Time	Method
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	After 20 days

Secondary Outcome Measures

Name	Time	Method
The change in the one-second-value in the forced vital capacity	After 20 days
The mean change in PC20 of methacholine, as a measure of direct airway hyperresponsiveness	After 20 days

Trial Locations

Locations (2)

University Hospital Ghent; 🇧🇪 Ghent, Belgium

CHU Sart Tilman ULG; 🇧🇪 Liège, Belgium