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

NCT ID: NCT02622243

Last Updated: 2016-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-03-31

Brief Summary

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

Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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tiotropium

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

Group Type EXPERIMENTAL

Tiotropium

Intervention Type DRUG

long acting muscarinic antagonist

Respimat

Intervention Type DEVICE

inhaler device used to deliver active tiotropium or placebo

Breezehaler

Intervention Type DEVICE

inhaler device used to deliver active glycopyrronium or placebo

glycopyrronium

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

Group Type EXPERIMENTAL

glycopyrronium

Intervention Type DRUG

long acting muscarinic antagonist

Respimat

Intervention Type DEVICE

inhaler device used to deliver active tiotropium or placebo

Breezehaler

Intervention Type DEVICE

inhaler device used to deliver active glycopyrronium or placebo

Interventions

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Tiotropium

long acting muscarinic antagonist

Intervention Type DRUG

glycopyrronium

long acting muscarinic antagonist

Intervention Type DRUG

Respimat

inhaler device used to deliver active tiotropium or placebo

Intervention Type DEVICE

Breezehaler

inhaler device used to deliver active glycopyrronium or placebo

Intervention Type DEVICE

Other Intervention Names

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Spiriva Seebri

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Saskatchewan

OTHER

Sponsor Role lead

Responsible Party

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Don Cockcroft

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Don Cockcroft, MD

Role: PRINCIPAL_INVESTIGATOR

University of Saskatchewan

Locations

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Asthma Research Lab

Saskatoon, Saskatchewan, Canada

Site Status

Countries

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Canada

References

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Blais CM, Davis BE, Cockcroft DW. Duration of bronchoprotection of the long-acting muscarinic antagonists tiotropium & glycopyrronium against methacholine-induced bronchoconstriction in mild asthmatics. Respir Med. 2016 Sep;118:96-101. doi: 10.1016/j.rmed.2016.07.017. Epub 2016 Jul 30.

Reference Type DERIVED
PMID: 27578477 (View on PubMed)

Other Identifiers

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Bio REB 15-254

Identifier Type: -

Identifier Source: org_study_id

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