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

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ClinicalTrials.gov Identifier: NCT02622243
Recruitment Status : Completed
First Posted : December 4, 2015
Last Update Posted : April 20, 2016
Sponsor:
Information provided by (Responsible Party):
Don Cockcroft, University of Saskatchewan

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
Asthma Drug: Tiotropium Drug: glycopyrronium Device: Respimat Device: Breezehaler Phase 4

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Study Type : Interventional  (Clinical Trial)
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 : November 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Seebri

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

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




Primary Outcome Measures :
  1. Change from baseline methacholine bronchoprotection at 96 hours [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: pre treatment versus 72 hours post treatment ]
    assessed by dose shift of geometric mean methacholine PC20 data



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02622243


Locations
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Canada, Saskatchewan
Asthma Research Lab
Saskatoon, Saskatchewan, Canada, S7N 0W8
Sponsors and Collaborators
University of Saskatchewan
Investigators
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Principal Investigator: Don Cockcroft, MD University of Saskatchewan

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Don Cockcroft, Professor, University of Saskatchewan
ClinicalTrials.gov Identifier: NCT02622243     History of Changes
Other Study ID Numbers: Bio REB 15-254
First Posted: December 4, 2015    Key Record Dates
Last Update Posted: April 20, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: journal publication
Additional relevant MeSH terms:
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Tiotropium Bromide
Methacholine Chloride
Muscarinic Antagonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Miotics
Parasympathomimetics
Bronchoconstrictor Agents
Muscarinic Agonists
Cholinergic Agonists