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

NCT02622243 — Phase 4, Completed, 13 participants, University of Saskatchewan

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

Registry	NCT02622243
Status	Completed
Phase	Phase 4
Study type	Interventional; randomized, crossover, masking: triple, treatment
Enrollment	13 (Actual)
Sponsor	University of Saskatchewan (Other)
Conditions	Asthma
Interventions	Tiotropium, glycopyrronium, Respimat, Breezehaler (Drug, device)
Dates	start 2015-11-01, primary completion 2016-03-01, completion 2016-03-01, first posted 2015-12-04, last updated 2016-04-20
Locations	1 site in Canada

-Summary

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

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+Arms and interventions

Arm	Type	Interventions	Description
tiotropium	Experimental	Drug: Tiotropium; Device: Respimat; Device: 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	Experimental	Drug: glycopyrronium; Device: Respimat; Device: Breezehaler	1 inhalation of 50mcg glycopyrronium from Breezehaler and 2 inhalations from placebo Respimat inhaler 1 hour prior to methacholine challenge

Tiotropium (Drug), also known as Spiriva: long acting muscarinic antagonist
glycopyrronium (Drug), also known as Seebri: long acting muscarinic antagonist
Respimat (Device): inhaler device used to deliver active tiotropium or placebo
Breezehaler (Device): inhaler device used to deliver active glycopyrronium or placebo

+Outcome measures

Primary outcomes

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 outcomes

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 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 72 hours [pre treatment versus 72 hours post treatment]: assessed by dose shift of geometric mean methacholine PC20 data

+Eligibility

Sex: All, ages: 19 Years to any

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

+Locations (1)

Facility	City	Country	Status
Asthma Research Lab	Saskatoon, Saskatchewan	Canada

+Publications

Results publication: 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. PMID 27578477

+Investigators

Don Cockcroft, MD, Principal investigator, University of Saskatchewan

My Notes

Public

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