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

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ClinicalTrials.gov Identifier: NCT00605410
Recruitment Status : Completed
First Posted : January 31, 2008
Last Update Posted : January 7, 2009
Sponsor:
Collaborator:
Royal University Hospital Foundation
Information provided by:
University of Saskatchewan

Brief Summary:
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 or disease Intervention/treatment Phase
Asthma Drug: ipratropium bromide Drug: placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
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
Study Start Date : January 2008
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



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


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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

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

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 Posted: January 31, 2008    Key Record Dates
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