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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00557700

Enrollment

Registered

2007-11-14

Start date

2008-01-31

Completion date

2010-05-31

Last updated

2010-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Mild to moderate asthma

Brief summary

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

Interventions

DRUGAdministration of inhaled tiotropium bromide

Administration of inhaled tiotropium bromide

DRUGAdministration of placebo

Administration of placebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	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

Measure	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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026