Status:

COMPLETED

Effect of Vilanterol on Methacholine Challenge Results

Lead Sponsor:

University of Saskatchewan

Conditions:

Asthma

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief Summary

The study will assess the degree of bronchoprotection provided by the ultra long-acting beta2 agonist vilanterol against methacholine-induced bronchoconstriction.

Detailed Description

This will be a double-blind, three-way crossover study comparing combination vilanterol+fluticasone with fluticasone monotherapy and a placebo (vilanterol is not available as a monotherapy). The order...

Eligibility Criteria

Inclusion

  • men and women aged 18 or older
  • stable mild-to-moderate asthma
  • baseline methacholine PC20 less than or equal to 8mg/mL
  • FEV1 greater than or equal to 65% of predicted

Exclusion

  • Use of long-acting anticholinergic or long-acting beta2 agonist within 30 days of study
  • pregnant or nursing
  • diabetes
  • hypokalemia
  • cardiovascular, prostate, kidney, or urinary retention problems
  • lactose-intolerant
  • allergy-induced asthma symptoms or upper respiratory tract infection within four weeks of study
  • current smokers
  • past smokers with smoking history \>10 pack years

Key Trial Info

Start Date :

October 13 2017

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 1 2018

Estimated Enrollment :

17 Patients enrolled

Trial Details

Trial ID

NCT03315000

Start Date

October 13 2017

End Date

May 1 2018

Last Update

October 11 2018

Active Locations (1)

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Asthma Research Lab - University of Saskatchewan

Saskatoon, Saskatchewan, Canada, S7N 0W8