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

NCT ID: NCT00557700

Last Updated: 2010-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-05-31

Brief Summary

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

Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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2

Administration of placebo

Group Type PLACEBO_COMPARATOR

Administration of placebo

Intervention Type DRUG

Administration of placebo

1

Administration of inhaled tiotropium bromide

Group Type EXPERIMENTAL

Administration of inhaled tiotropium bromide

Intervention Type DRUG

Administration of inhaled tiotropium bromide

Interventions

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Administration of inhaled tiotropium bromide

Administration of inhaled tiotropium bromide

Intervention Type DRUG

Administration of placebo

Administration of placebo

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role collaborator

University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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University Ghent

Principal Investigators

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Guy Joos, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

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University Hospital Ghent

Ghent, , Belgium

Site Status

CHU Sart Tilman ULG

Liège, , Belgium

Site Status

Countries

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Belgium

Related Links

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http://www.uzgent.be

Website University Hospital Ghent

Other Identifiers

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2007/378

Identifier Type: -

Identifier Source: org_study_id

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