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

Phase 4

Completed

• Conditions: Asthma
• Interventions: Drug: glycopyrronium; Drug: Tiotropium; Device: Respimat; Device: Breezehaler

• Registration Number: NCT02622243
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-27
• Study First Submitted QC: 2015-12-03
• Study First Posted: 2015-12-04
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-19
• Last Update Posted: 2016-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
glycopyrronium	glycopyrronium	1 inhalation of 50mcg glycopyrronium from Breezehaler and 2 inhalations from placebo Respimat inhaler 1 hour prior to methacholine challenge
tiotropium	Tiotropium	2 inhalations of 2.5mcg/inhalation tiotropium from Respimat inhaler and 1 inhalation of placebo from Breezehaler 1 hour prior to methacholine challenge
tiotropium	Respimat	2 inhalations of 2.5mcg/inhalation tiotropium from Respimat inhaler and 1 inhalation of placebo from Breezehaler 1 hour prior to methacholine challenge
tiotropium	Breezehaler	2 inhalations of 2.5mcg/inhalation tiotropium from Respimat inhaler and 1 inhalation of placebo from Breezehaler 1 hour prior to methacholine challenge
glycopyrronium	Respimat	1 inhalation of 50mcg glycopyrronium from Breezehaler and 2 inhalations from placebo Respimat inhaler 1 hour prior to methacholine challenge
glycopyrronium	Breezehaler	1 inhalation of 50mcg glycopyrronium from Breezehaler and 2 inhalations from placebo Respimat inhaler 1 hour prior to methacholine challenge

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
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
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

Trial Locations

Locations (1)

Asthma Research Lab; 🇨🇦 Saskatoon, Saskatchewan, Canada