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

NCT00529477 | Completed

• 1 other identifier: NEB3-AIR
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (2)

• To examine the functional effects of methacholine challenge on small airways via plethysmography and impulse oscillation techniques

  April 2008

• To compare the sensitivity of these measurement techniques to detect changes in small airways.

  April 2008

Study Arms (3)

1

ACTIVE COMPARATOR

The Wright Nebulizer will be used to perform the methacholine challenge in arm 1.

Other: 1. Wright Nebulizer

2

ACTIVE COMPARATOR

The Pari LC nebulizer will be used to perform the methacholine challenge in arm 2.

Other: Pari LC Nebulizer

3

ACTIVE COMPARATOR

The Pari Sinustar nebulizer will be used to perform the methacholine challenge in arm 3.

Other: The Pari Sinustar Nebulizer

Interventions

1. Wright Nebulizer OTHER

The Wright nebulizer will be used to perform the methacholine challenge.

1

Pari LC Nebulizer OTHER

The Pari LC nebulizer will be used to perform the methacholine challenge.

2

The Pari Sinustar Nebulizer OTHER

The Pari Sinustar nebulizer will be used to perform the methacholine challenge.

3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead

Study Sites (1)

McMaster University

Hamilton, Ontario, L8N 3Z5, Canada

Location

Related Publications (1)

• Naji N, Keung E, Beaudin S, Kane J, Killian KJ, Gauvreau GM. The effects of particle size on measurement of airway hyperresponsiveness to methacholine. Ann Allergy Asthma Immunol. 2013 May;110(5):359-63. doi: 10.1016/j.anai.2013.02.014. Epub 2013 Mar 19.

  PMID: 23622007 DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Kieran Killian, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 7, 2007
• First Posted: September 14, 2007
• Study Start: September 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: October 21, 2009

Record last verified: 2009-10

Locations

CA (1)