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

This study has been completed.
Boehringer Ingelheim
Information provided by:
University Hospital, Ghent Identifier:
First received: November 12, 2007
Last updated: June 15, 2010
Last verified: June 2010
This trial compares the outcome of treatment of mild to moderate asthma: inhaled tiotropium bromide versus placebo.

Condition Intervention Phase
Drug: Administration of inhaled tiotropium bromide
Drug: Administration of placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Study to Investigate the Effect of Inhaled Tiotropium Bromide on Neurokinin-A Induced Bronchoconstriction in Patients With Mild-to-moderate Asthma

Resource links provided by NLM:

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • 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 ]

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

Estimated Enrollment: 15
Study Start Date: January 2008
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00557700

University Hospital Ghent
Ghent, Belgium, 9000
CHU Sart Tilman ULG
Liège, Belgium, 4000
Sponsors and Collaborators
University Hospital, Ghent
Boehringer Ingelheim
Principal Investigator: Guy Joos, MD, PhD University Hospital, Ghent
  More Information

Additional Information:
Responsible Party: Guy Joos, MD, PhD, University Ghent Identifier: NCT00557700     History of Changes
Other Study ID Numbers: 2007/378
Study First Received: November 12, 2007
Last Updated: June 15, 2010

Keywords provided by University Hospital, Ghent:
Mild to moderate asthma

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Neurokinin A
Tiotropium Bromide
Substance P
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Cholinergic Antagonists
Cholinergic Agents
Anticonvulsants processed this record on April 28, 2017