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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00557700
• Other study ID #: 2007/378
• Status: Completed
• Phase: Phase 2
• First received: November 12, 2007
• Last updated: June 15, 2010
• Start date: January 2008
• Est. completion date: May 2010

Study information

• Verified date: June 2010
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Administration of inhaled tiotropium bromide
Administration of inhaled tiotropium bromide
• Administration of placebo
Administration of placebo

Locations

Country	Name	City	State
Belgium	University Hospital Ghent	Ghent
Belgium	CHU Sart Tilman ULG	Liège

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Ghent	Boehringer Ingelheim

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	The change in the one-second-value in the forced vital capacity		After 20 days	No
Secondary	The mean change in PC20 of methacholine, as a measure of direct airway hyperresponsiveness		After 20 days	No

External Links

•   Website University Hospital Ghent