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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02622243
• Other study ID #: Bio REB 15-254
• Status: Completed
• Phase: Phase 4
• First received: November 27, 2015
• Last updated: April 19, 2016
• Start date: November 2015
• Est. completion date: March 2016

Study information

• Verified date: April 2016
• Source: University of Saskatchewan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Tiotropium
long acting muscarinic antagonist
• glycopyrronium
long acting muscarinic antagonist

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

Locations

Country	Name	City	State
Canada	Asthma Research Lab	Saskatoon	Saskatchewan

Sponsors (1)

Lead Sponsor	Collaborator
University of Saskatchewan

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline methacholine bronchoprotection at 96 hours	assessed by dose shift of geometric mean methacholine PC20 data	pre treatment versus 96 hour post treatment	No
Secondary	Change from baseline methacholine bronchoprotection at 1 hour	assessed by dose shift of geometric mean methacholine PC20 data	pre treatment versus 1 hour post treatment	No
Secondary	Change from baseline methacholine bronchoprotection at 24 hours	assessed by dose shift of geometric mean methacholine PC20 data	pre treatment versus 24 hours post treatment	No
Secondary	Change from baseline methacholine bronchoprotection at 48 hours	assessed by dose shift of geometric mean methacholine PC20 data	pre treatment versus 48 hours post treatment	No
Secondary	Change from baseline methacholine bronchoprotection at 72 hours	assessed by dose shift of geometric mean methacholine PC20 data	pre treatment versus 72 hours post treatment	No