Effect of Vilanterol on Methacholine Challenge Results

October 9, 2018 updated by: Don Cockcroft, University of Saskatchewan

The Effect of Vilanterol Against Methacholine-induced Bronchoconstriction in Mild Asthmatics

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 in which the treatments are given will be randomized and each treatment will be separated by a minimum one-week washout. Fifteen asthmatic participants will be recruited from the local community. Methacholine challenge testing (MCT) with the two-minute tidal breathing protocol will be used to quantify the bronchoprotective effects (if any) of each treatment against methacholine-induced bronchoconstriction.

Each participant will undergo a total of nine methacholine challenges. After a baseline methacholine challenge, the randomized treatment (identity unknown to investigator or participant) will be administered through an Ellipta® (multi-dose dry powder inhaler). Thirty minutes following treatment administration, a second methacholine challenge will be performed. At 24 hours post-treatment, each participant must re-visit the lab for one methacholine challenge. The same process will be followed for each treatment.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 0W8
        • Asthma Research Lab - University of Saskatchewan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vilanterol
Vilanterol (25mcg)+ fluticasone (100mcg) inhaled through Ellipta® inhaler
Drug: Vilanterol and Fluticasone Furoate
Same as vilanterol arm description
Other Names:
  • Breo
Experimental: Fluticasone
Fluticasone (100mcg) monotherapy inhaled through Ellipta® inhaler
Drug: Fluticasone Furoate
Same as fluticasone arm description
Other Names:
  • Arnuity
Placebo Comparator: Placebo
Lactose powder inhaled through Ellipta® inhaler
Drug: Placebos
Same as placebo arm description
Other Names:
  • lactose powder

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline methacholine PC20 (bronchoprotection) at 30 min post-treatment
Time Frame: baseline versus 30 min post-treatment
assessed by dose shift of geometric mean methacholine PC20 data
baseline versus 30 min post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline methacholine PC20 (bronchoprotection) at 24 hours post-treatment
Time Frame: baseline versus 24 hours post-treatment
assessed by dose shift of geometric mean methacholine PC20 data
baseline versus 24 hours post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Saskatchewan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 13, 2017

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

October 16, 2017

First Submitted That Met QC Criteria

October 16, 2017

First Posted (Actual)

October 19, 2017

Study Record Updates

Last Update Posted (Actual)

October 11, 2018

Last Update Submitted That Met QC Criteria

October 9, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VIL-2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Journal Publication

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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