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

April 19, 2016 updated by: Don Cockcroft, University of Saskatchewan

Duration of Bronchoprotection of the Long Acting Muscarinic Antagonists Tiotropium and Glycopyrronium Against Methacholine Induced Bronchoconstriction

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 0W8
        • Asthma Research Lab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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
Device: Respimat
inhaler device used to deliver active tiotropium or placebo
Device: Breezehaler
inhaler device used to deliver active glycopyrronium or placebo
Drug: glycopyrronium
long acting muscarinic antagonist
Other Names:
  • Seebri

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
pre treatment versus 96 hour post treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
pre treatment versus 1 hour post treatment
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
pre treatment versus 24 hours post treatment
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
pre treatment versus 48 hours post treatment
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
pre treatment versus 72 hours post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Saskatchewan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

November 27, 2015

First Submitted That Met QC Criteria

December 3, 2015

First Posted (Estimate)

December 4, 2015

Study Record Updates

Last Update Posted (Estimate)

April 20, 2016

Last Update Submitted That Met QC Criteria

April 19, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bio REB 15-254

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

journal publication

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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