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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02622243

Enrollment

Registered

2015-12-04

Start date

2015-11-30

Completion date

2016-03-31

Last updated

2016-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Brief summary

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

Interventions

DRUGTiotropium

long acting muscarinic antagonist

DRUGglycopyrronium

long acting muscarinic antagonist

DEVICERespimat

inhaler device used to deliver active tiotropium or placebo

DEVICEBreezehaler

inhaler device used to deliver active glycopyrronium or placebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026