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

University of Saskatchewan

Status and phase: Completed; Phase 4

Conditions: Asthma

Treatments: Device: Respimat; Device: Breezehaler; Drug: glycopyrronium; Drug: Tiotropium

Study type: Interventional

Funder types: Other

Identifiers

NCT02622243

Bio REB 15-254

Details and patient eligibility

About

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

Enrollment: 13 patients

Sex: All

Ages: 19+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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13 participants in 2 patient groups

tiotropium

Experimental group

Description:

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

Treatment:

Drug: Tiotropium

Device: Respimat

Device: Breezehaler

glycopyrronium

Experimental group

Description:

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

Treatment:

Drug: glycopyrronium

Device: Respimat

Device: Breezehaler