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

Ghent University Hospital (UZ)

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: Administration of placebo; Drug: Administration of inhaled tiotropium bromide

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00557700

2007/378

Details and patient eligibility

About

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

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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15 participants in 2 patient groups, including a placebo group

2

Placebo Comparator group

Description:

Administration of placebo

Treatment:

Drug: Administration of placebo

1

Experimental group

Description:

Administration of inhaled tiotropium bromide

Treatment:

Drug: Administration of inhaled tiotropium bromide