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

Primary Purpose

Asthma

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
ipratropium bromide
placebo
Sponsored by
University of Saskatchewan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Asthma focused on measuring Methacholine bronchoprovocation, Antimuscarinic

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Concomitant lung disease other than asthma

Sites / Locations

  • University of Saskatchewan

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

methacholine PC20

Secondary Outcome Measures

Full Information

First Posted
January 18, 2008
Last Updated
January 6, 2009
Sponsor
University of Saskatchewan
Collaborators
Royal University Hospital Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00605410
Brief Title
Duration of Protective Effect From Inhaled Ipratropium Bromide on Methacholine Airway Hyperresponsiveness
Official Title
Duration of Protective Effect From Inhaled Ipratropium Bromide on Methacholine Airway Hyperresponsiveness
Study Type
Interventional

2. Study Status

Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Saskatchewan
Collaborators
Royal University Hospital Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Methacholine bronchoprovocation, Antimuscarinic

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ipratropium bromide
Other Intervention Name(s)
Atrovent HFA Inhalation Aerosol
Intervention Description
2 puffs (40 micrograms) 2 puffs (0micrograms)
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Matched placebo
Primary Outcome Measure Information:
Title
methacholine PC20
Time Frame
6hours and 12 hours post inhalation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald W Cockcroft, MD
Organizational Affiliation
Department of Medicine University of Saskatchewan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Saskatchewan
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N oW8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
19496252
Citation
Illamperuma C, Davis BE, Fenton ME, Cockcroft DW. Duration of bronchoprotection of inhaled ipratropium against inhaled methacholine. Ann Allergy Asthma Immunol. 2009 May;102(5):438-9. doi: 10.1016/S1081-1206(10)60519-4. No abstract available.
Results Reference
derived

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

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