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

June 15, 2010 updated by: University Hospital, Ghent
This trial compares the outcome of treatment of mild to moderate asthma: inhaled tiotropium bromide versus placebo.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • University Hospital Ghent
      • Liège, Belgium, 4000
        • CHU Sart Tilman ULG

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Administration of placebo
Drug: Administration of placebo
Administration of placebo
Experimental: 1
Administration of inhaled tiotropium bromide
Drug: Administration of inhaled tiotropium bromide
Administration of inhaled tiotropium bromide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: After 20 days
After 20 days

Secondary Outcome Measures

Outcome Measure
Time Frame
The change in the one-second-value in the forced vital capacity
Time Frame: After 20 days
After 20 days
The mean change in PC20 of methacholine, as a measure of direct airway hyperresponsiveness
Time Frame: After 20 days
After 20 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Collaborators

Boehringer Ingelheim

Investigators

  • Principal Investigator: Guy Joos, MD, PhD, University Hospital, Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

November 12, 2007

First Submitted That Met QC Criteria

November 13, 2007

First Posted (Estimate)

November 14, 2007

Study Record Updates

Last Update Posted (Estimate)

June 16, 2010

Last Update Submitted That Met QC Criteria

June 15, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007/378

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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