search
Back to results

The Correlation Between Airway Inflammation and Loss of Deep Inhalation Bronchoprotection in Asthmatics

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
deep inhalation
Sponsored by
University of Saskatchewan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Asthma

Eligibility Criteria

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

Inclusion Criteria:

  • diagnosis of asthma

Exclusion Criteria:

  • other lung disease(s)
  • smoking

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    Standard

    Modified

    Arm Description

    Methacholine challenges are performed using the standardized two minute tidal breathing method

    Five deep inhalation maneouvers are incorporated into the standardized methacholine challenge

    Outcomes

    Primary Outcome Measures

    fraction of exhaled nitric oxide, sputum eosinophils and methacholine PC20

    Secondary Outcome Measures

    Full Information

    First Posted
    November 27, 2006
    Last Updated
    January 18, 2008
    Sponsor
    University of Saskatchewan
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00404677
    Brief Title
    The Correlation Between Airway Inflammation and Loss of Deep Inhalation Bronchoprotection in Asthmatics
    Official Title
    The Correlation Between Airway Inflammation and Loss of Deep Inhalation Bronchoprotection in Asthmatics
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2006 (undefined)
    Primary Completion Date
    February 2007 (Actual)
    Study Completion Date
    February 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of Saskatchewan

    4. Oversight

    5. Study Description

    Brief Summary
    The loss of deep inhalation bronchoprotection in asthmatic individuals has been shown to be related to the degree of airway hyperresponsiveness, a hallmark of asthma. In several studies, asthmatic individuals with mild airway hyperresponsiveness (AHR) (methacholine PC20 > 2 mg/mL) had a difference in methacholine PC20 with and without deep inhalations that averaged 1.8 doubling methacholine concentrations (p=0.0003). Conversely, asthmatic individuals with moderate to severe AHR (methacholine PC20 ≤ 2 mg/mL) had a non-significant difference in methacholine PC20 with and without deep inhalations (p=0.09). This loss of deep inhalation bronchoprotection is also now believed to play an important role in the pathogenesis of asthma. Airway inflammation is another of the key features of asthma and information on airway inflammation is increasingly being used in the diagnosis and treatment of asthma. The level of airway inflammation (as measured by fraction of exhaled nitric oxide and sputum eosinophilia) has also been shown to be correlated to the level of airway hyperresponsiveness (as measured by methacholine PC20). In addition, glucocorticoids have been shown to decrease airway hyperresponsiveness, further suggesting that these two phenomena, airway inflammation and airway hyperresponsiveness, are related. We therefore suggest that the degree of airway inflammation is related to the loss of deep inhalation bronchoprotection and expect there to be a negative correlation between the degree of deep inhalation bronchoprotection and airway inflammation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Asthma

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    18 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard
    Arm Type
    Placebo Comparator
    Arm Description
    Methacholine challenges are performed using the standardized two minute tidal breathing method
    Arm Title
    Modified
    Arm Type
    Active Comparator
    Arm Description
    Five deep inhalation maneouvers are incorporated into the standardized methacholine challenge
    Intervention Type
    Other
    Intervention Name(s)
    deep inhalation
    Intervention Description
    deep inhalation is comprised of an inhalation manoeuver from FRC to TLC
    Primary Outcome Measure Information:
    Title
    fraction of exhaled nitric oxide, sputum eosinophils and methacholine PC20
    Time Frame
    freaction of exhaled nitric oxide data collected prior to methacholine challenges; sputum collected after the first methacholine challenge

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: diagnosis of asthma Exclusion Criteria: other lung disease(s) smoking
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Donald Cockcroft, MD, FRCP(C)
    Organizational Affiliation
    Department of Medicine, Division of Respirology, Critical Care and Sleep Medicine, University of Saskatchewan
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    The Correlation Between Airway Inflammation and Loss of Deep Inhalation Bronchoprotection in Asthmatics

    We'll reach out to this number within 24 hrs