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

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Ghent
• Collaborator: Boehringer Ingelheim
• Treatments: Bromides; Neurokinin A; Substance P; Tiotropium Bromide

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.