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

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ClinicalTrials.gov Identifier: NCT00529477
Recruitment Status : Completed
First Posted : September 14, 2007
Last Update Posted : October 21, 2009
Sponsor:
Information provided by:
McMaster University

Brief Summary:
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 or disease Intervention/treatment Phase
Asthma Other: 1. Wright Nebulizer Other: Pari LC Nebulizer Other: The Pari Sinustar Nebulizer Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Effects of Methacholine Challenge Administered Using Three Different Nebulizers on Small Airways Function
Study Start Date : September 2007
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

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Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. To examine the functional effects of methacholine challenge on small airways via plethysmography and impulse oscillation techniques [ Time Frame: April 2008 ]
  2. To compare the sensitivity of these measurement techniques to detect changes in small airways. [ Time Frame: April 2008 ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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): 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

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
First Posted: September 14, 2007    Key Record Dates
Last Update Posted: October 21, 2009
Last Verified: October 2009

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