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The Effects Of Methacholine Challenge Administered Using Three Different Nebulizers On Small Airways Function

This study has been completed.
Sponsor:
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00529477
First received: September 7, 2007
Last updated: October 20, 2009
Last verified: October 2009
  Purpose

The objective of this study is to examine the functional effects of methacholine challenge on small airways using three different nebulizers to generate particles with HMAD suitable for distribution in small, intermediate and large airways.Pulmonary function will be assessed using plethysmography and impulse oscillation techniques. Eight asthmatic subjects (>18 years, both sexes) who are stable clinically and require only intermittent ß2-agonist treatment will be recruited to undergo methacholine challenges for an in vivo, dose-finding observational study. Three separate methacholine challenges will be carried out using each of the three different nebulizers. After each challenge, pulmonary function tests will be performed on subjects to assess functional changes in large and small airways. Results of the tests will be compared between the three nebulizers. These experiments will demonstrate whether or not functional changes occur in small airways in response to methacholine, as measured by pulmonary function tests after selectively targeting small airways using the nebulizer which generates small particles. The results from these experiments will give us a better understanding of the role of small airways in methacholine-induced bronchoconstriction in asthmatics, and will compare sensitivity of plethysmography compared to forced oscillation for detecting changes in small airways.


Condition Intervention
Asthma
Other: 1. Wright Nebulizer
Other: Pari LC Nebulizer
Other: The Pari Sinustar Nebulizer

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: The Effects of Methacholine Challenge Administered Using Three Different Nebulizers on Small Airways Function

Further study details as provided by McMaster University:

Primary Outcome Measures:
  • To examine the functional effects of methacholine challenge on small airways via plethysmography and impulse oscillation techniques [ Time Frame: April 2008 ] [ Designated as safety issue: No ]
  • To compare the sensitivity of these measurement techniques to detect changes in small airways. [ Time Frame: April 2008 ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: September 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
The Wright Nebulizer will be used to perform the methacholine challenge in arm 1.
Other: 1. Wright Nebulizer
The Wright nebulizer will be used to perform the methacholine challenge.
Active Comparator: 2
The Pari LC nebulizer will be used to perform the methacholine challenge in arm 2.
Other: Pari LC Nebulizer
The Pari LC nebulizer will be used to perform the methacholine challenge.
Active Comparator: 3
The Pari Sinustar nebulizer will be used to perform the methacholine challenge in arm 3.
Other: The Pari Sinustar Nebulizer
The Pari Sinustar nebulizer will be used to perform the methacholine challenge.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Mild asthmatics, presently well controlled on ß2-agonists.
  • Non-smokers.
  • Baseline FEV1 more than 70% of predicted normal.

Exclusion Criteria:

  • Airway infection during the last 4 weeks.
  • Exacerbation during the last 4 weeks.
  • Inhaled or oral steroids during the last 4 weeks.
  • Antihistamines during the last 48 hours.
  • Asthma medication other than inhaled and/or oral ß2-agonists during the last 4 weeks.
  • Pregnant women.
  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: NCT00529477

Locations
Canada, Ontario
McMaster University
Hamilton, Ontario, Canada, L8N 3Z5
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Investigators
Principal Investigator: Kieran Killian, MD McMaster University
  More Information

No publications provided by McMaster University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gail Gauvreau, McMaster University
ClinicalTrials.gov Identifier: NCT00529477     History of Changes
Other Study ID Numbers: NEB3-AIR
Study First Received: September 7, 2007
Last Updated: October 20, 2009
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Methacholine Chloride
Autonomic Agents
Bronchoconstrictor Agents
Cholinergic Agents
Cholinergic Agonists
Miotics
Molecular Mechanisms of Pharmacological Action
Muscarinic Agonists
Neurotransmitter Agents
Parasympathomimetics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014