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

Condition(s) targeted: Asthma

Intervention: Administration of inhaled tiotropium bromide (Drug); Administration of placebo (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: University Hospital, Ghent

Official(s) and/or principal investigator(s):
Guy Joos, MD, PhD, Principal Investigator, Affiliation: University Hospital, Ghent

Overall contact:
Yannick van Durme, MD, Phone: 0032/(0)9/332.55.98, Email: yannick.vandurme@Ugent.be

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

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

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study

Primary outcome: 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

Secondary outcome:

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

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Yannick van Durme, MD, Phone: 0032/(0)9/332.55.98, Email: yannick.vandurme@Ugent.be

University Hospital Ghent, Ghent 9000, Belgium; Recruiting
Yannick van Durme, MD, Phone: 0032/(0)9/332.55.98, Email: yannick.vandurme@Ugent.be
Yannick van Durme, MD, Principal Investigator

CHU Sart Tilman ULG, Liège 4000, Belgium; Recruiting
Renaud Louis, MD, PhD
Renaud Louis, MD, PhD, Principal Investigator

Website University Hospital Ghent

Starting date: January 2008
Ending date: December 2010
Last updated: April 9, 2009