Effect of a LAMA and a uLABA on the Methacholine Dose-response Curve

• Status: Completed
• Trial end date: 2017-01-09
• Target enrollment: 0
• Participant gender: All

Summary

The study will assess the effects of two drugs, glycopyrronium and indacaterol, taken either as monotherapy or in combination, on the methacholine dose-response curve. This will allow for further elucidation of the mechanisms of each drug in human participants.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Saskatchewan
• Treatments: Bromides; Glycopyrrolate; Methacholine Chloride

Criteria

Inclusion Criteria:

• men and women aged 18 or older

• stable mild-to-moderate asthma

• baseline methacholine PC20 less than or equal to 8mg/mL and FEV1 greater than or equal to 65% of predicted (asthmatic participants)

• baseline methacholine PC20 greater than 16mg/mL (healthy participants)

Exclusion Criteria:

• use of long-acting bronchodilators or long-acting muscarinic antagonists within 30 days of Visit 1

• pregnant or lactating

• cardiovascular, prostate, kidney or urinary retention problems

• respiratory illness within 4 weeks of Visit 1

• allergen-induced asthma exacerbating within 4 weeks of Visit 1

• hypokalemia

• diabetes

• glaucoma

• smokers and exsmokers with greater than 10 pack years