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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.
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by:
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00557700
First received: November 12, 2007
Last updated: June 15, 2010
Last verified: June 2010
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The change in the one-second-value in the forced vital capacity [ Time Frame: After 20 days ] [ Designated as safety issue: No ]
  • The mean change in PC20 of methacholine, as a measure of direct airway hyperresponsiveness [ Time Frame: After 20 days ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00557700

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

Additional Information:
No publications provided

Responsible Party: Guy Joos, MD, PhD, University Ghent
ClinicalTrials.gov Identifier: NCT00557700     History of Changes
Other Study ID Numbers: 2007/378
Study First Received: November 12, 2007
Last Updated: June 15, 2010
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

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

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Bromides
Neurokinin A
Tiotropium
Anti-Asthmatic Agents
Anticonvulsants
Autonomic Agents
Bronchodilator Agents
Central Nervous System Agents
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Parasympatholytics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 19, 2014