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

This study has been completed.

Sponsors and Collaborators:	University of Saskatchewan Royal University Hospital Foundation
Information provided by:	University of Saskatchewan
ClinicalTrials.gov Identifier:	NCT00605410

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 IV

MedlinePlus related topics: Asthma

Drug Information available for: Methacholine Methacholine chloride Ipratropium Ipratropium bromide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment
Official Title:	Duration of Protective Effect From Inhaled Ipratropium Bromide on Methacholine Airway Hyperresponsiveness

Further study details as provided by University of Saskatchewan:

Primary Outcome Measures:

methacholine PC20 [ Time Frame: 6hours and 12 hours post inhalation ] [ Designated as safety issue: No ]

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
1: Active Comparator	Drug: ipratropium bromide 2 puffs (40 micrograms) 2 puffs (0micrograms)
2: Placebo Comparator	Drug: placebo Matched placebo

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
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

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

Responsible Party:	Department of Medicine, University of Saskatchewan ( Dr. Donald W. Cockcroft )
Study ID Numbers:	BIO 07-161
Study First Received:	January 18, 2008
Last Updated:	January 6, 2009
ClinicalTrials.gov Identifier:	NCT00605410
Health Authority:	Canada: Health Canada

Keywords provided by University of Saskatchewan:

Methacholine bronchoprovocation
Antimuscarinic

Study placed in the following topic categories:

Ipratropium
Bromides
Methacholine Chloride
Asthma

Additional relevant MeSH terms:

Parasympathomimetics
Respiratory System Agents
Neurotransmitter Agents
Cholinergic Agonists
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Bronchoconstrictor Agents
Miotics
Physiological Effects of Drugs
Anti-Asthmatic Agents

Cholinergic Agents
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Muscarinic Agonists
Peripheral Nervous System Agents
Central Nervous System Agents
Bronchodilator Agents
Anticonvulsants

ClinicalTrials.gov processed this record on January 14, 2009