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

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

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

Conditions
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Asthma

Intervention / Treatment
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* Drug: Administration of inhaled tiotropium bromide
* Drug: Administration of placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 2<br>Administration of placebo | Drug: Administration of placebo<br>* Administration of placebo<br>|
| Experimental: 1<br>Administration of inhaled tiotropium bromide | Drug: Administration of inhaled tiotropium bromide<br>* Administration of inhaled tiotropium bromide<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mild to moderate asthma