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
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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COMPLETED
PHASE2
15 participants
INTERVENTIONAL
2008-01-31
2010-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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2
Administration of placebo
Administration of placebo
Administration of placebo
1
Administration of inhaled tiotropium bromide
Administration of inhaled tiotropium bromide
Administration of inhaled tiotropium bromide
Interventions
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Administration of inhaled tiotropium bromide
Administration of inhaled tiotropium bromide
Administration of placebo
Administration of placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
University Hospital, Ghent
OTHER
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
CHU Sart Tilman ULG
Liège, , Belgium
Countries
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Related Links
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Website University Hospital Ghent
Other Identifiers
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2007/378
Identifier Type: -
Identifier Source: org_study_id
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