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Duration of Long Acting Muscarinic Antagonist (LAMA) Bronchoprotection Against Methacholine Challenge

Sponsor
University of Saskatchewan (Other)
Overall Status
Completed
CT.gov ID
NCT02622243
Collaborator
(none)
13
Enrollment
1
Location
2
Arms
4
Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study will assess the duration of protection of single doses of 2 different long acting muscarinic antagonists against methacholine induced bronchoconstriction.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
13 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Duration of Bronchoprotection of the Long Acting Muscarinic Antagonists Tiotropium and Glycopyrronium Against Methacholine Induced Bronchoconstriction
Study Start Date :
Nov 1, 2015
Actual Primary Completion Date :
Mar 1, 2016
Actual Study Completion Date :
Mar 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: tiotropium

2 inhalations of 2.5mcg/inhalation tiotropium from Respimat inhaler and 1 inhalation of placebo from Breezehaler 1 hour prior to methacholine challenge

Drug: Tiotropium
long acting muscarinic antagonist
Other Names:
  • Spiriva

    • Device: Respimat
    inhaler device used to deliver active tiotropium or placebo

    Device: Breezehaler
    inhaler device used to deliver active glycopyrronium or placebo
    Experimental: glycopyrronium

    1 inhalation of 50mcg glycopyrronium from Breezehaler and 2 inhalations from placebo Respimat inhaler 1 hour prior to methacholine challenge

    Drug: glycopyrronium
    long acting muscarinic antagonist
    Other Names:
  • Seebri

    • Device: Respimat
    inhaler device used to deliver active tiotropium or placebo

    Device: Breezehaler
    inhaler device used to deliver active glycopyrronium or placebo

    Outcome Measures

    Primary Outcome Measures

    1. Change from baseline methacholine bronchoprotection at 96 hours [pre treatment versus 96 hour post treatment]

      assessed by dose shift of geometric mean methacholine PC20 data

    Secondary Outcome Measures

    1. Change from baseline methacholine bronchoprotection at 1 hour [pre treatment versus 1 hour post treatment]

      assessed by dose shift of geometric mean methacholine PC20 data

    2. Change from baseline methacholine bronchoprotection at 24 hours [pre treatment versus 24 hours post treatment]

      assessed by dose shift of geometric mean methacholine PC20 data

    3. Change from baseline methacholine bronchoprotection at 48 hours [pre treatment versus 48 hours post treatment]

      assessed by dose shift of geometric mean methacholine PC20 data

    4. Change from baseline methacholine bronchoprotection at 72 hours [pre treatment versus 72 hours post treatment]

      assessed by dose shift of geometric mean methacholine PC20 data

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • male or female asthmatics > 19 years of age

    • baseline methacholine PC20 less than or equal to 4mg/ml

    • baseline lung function >65% predicted

    • non-smoker and less than 10 pack year smoking history

    Exclusion Criteria:

    • use of anticholinergic within 30 days of Visit 1

    • poorly controlled asthma

    • pregnant or nursing

    • respiratory illness within 4 weeks of Visit 1

    • exposure to an agent that triggered asthma worsening (e.g. allergen) within 4 weeks of Visit 1

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Asthma Research Lab Saskatoon Saskatchewan Canada S7N 0W8

    Sponsors and Collaborators

    • University of Saskatchewan

    Investigators

    • Principal Investigator: Don Cockcroft, MD, University of Saskatchewan

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Don Cockcroft, Professor, University of Saskatchewan
    ClinicalTrials.gov Identifier:
    NCT02622243
    Other Study ID Numbers:
    • Bio REB 15-254
    First Posted:
    Dec 4, 2015
    Last Update Posted:
    Apr 20, 2016
    Last Verified:
    Apr 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Additional relevant MeSH terms:
    Glycopyrrolate
    Tiotropium Bromide

    Study Results

    No Results Posted as of Apr 20, 2016