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Duration of Protective Effect From Inhaled Ipratropium Bromide on Methacholine Airway Hyperresponsiveness

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00605410
First Posted: January 31, 2008
Last Update Posted: January 7, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Royal University Hospital Foundation
Information provided by:
University of Saskatchewan
  Purpose
Certain lung disease medications can influence diagnostic tests and research investigations. This study will investigate how long ipratropium bromide must be withheld before a methacholine challenge test can be conducted. This information will be useful for validating current guidelines.

Condition Intervention Phase
Asthma Drug: ipratropium bromide Drug: placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Duration of Protective Effect From Inhaled Ipratropium Bromide on Methacholine Airway Hyperresponsiveness

Resource links provided by NLM:


Further study details as provided by University of Saskatchewan:

Primary Outcome Measures:
  • methacholine PC20 [ Time Frame: 6hours and 12 hours post inhalation ]

Enrollment: 12
Study Start Date: January 2008
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: ipratropium bromide
2 puffs (40 micrograms) 2 puffs (0micrograms)
Other Name: Atrovent HFA Inhalation Aerosol
Placebo Comparator: 2 Drug: placebo
Matched placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of asthma; stable and controlled
  • FEV1 greater than or equal to 65% predicted

Exclusion Criteria:

  • Concomitant lung disease other than asthma
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00605410


Locations
Canada, Saskatchewan
University of Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N oW8
Sponsors and Collaborators
University of Saskatchewan
Royal University Hospital Foundation
Investigators
Principal Investigator: Donald W Cockcroft, MD Department of Medicine University of Saskatchewan
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Donald W. Cockcroft, Department of Medicine, University of Saskatchewan
ClinicalTrials.gov Identifier: NCT00605410     History of Changes
Other Study ID Numbers: BIO 07-161
First Submitted: January 18, 2008
First Posted: January 31, 2008
Last Update Posted: January 7, 2009
Last Verified: July 2008

Keywords provided by University of Saskatchewan:
Methacholine bronchoprovocation
Antimuscarinic

Additional relevant MeSH terms:
Respiratory Hypersensitivity
Respiratory Tract Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Bromides
Ipratropium
Methacholine Chloride
Anticonvulsants
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Miotics
Parasympathomimetics
Bronchoconstrictor Agents
Muscarinic Agonists
Cholinergic Agonists