Effect of Fluticasone Furoate on Methacholine Challenge

December 9, 2019 updated by: Don Cockcroft, University of Saskatchewan

The Effect of Once-daily Fluticasone Furoate on Methacholine-induced Bronchoconstriction in Mild Asthmatics

The study will determine the effect of inhaled fluticasone furoate on airway responsiveness to methacholine in mild asthmatics.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

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 Room 346 Ellis Hall

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:

  • forced expiratory volume in one second (FEV1) greater than or equal to 65% predicted
  • methacholine PD20 less than or equal to 400mcg
  • no allergen exposure (if atopic) or respiratory infection for at least 4 weeks prior to study start

Exclusion Criteria:

  • regular use of inhaled corticosteroid within 4 weeks of study start
  • poorly controlled asthma
  • current smoker or ex smoker with greater than 10 pack year history
  • pregnancy or breast-feeding
  • health concern/condition that would preclude participation for safety reasons

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: Fluticasone Furoate

Daily inhalation of 100mcg fluticasone furoate for 7 days Response to methacholine induced bronchoconstriction will be assessed on Day 1 before first inhalation of study treatment (baseline) and again at 24, 72 and 168 hours.

The change in airway responsiveness to methacholine will be determined as a dose shift in methacholine PD20 from baseline to each of the three timepoints
Drug: Fluticasone furoate
Inhaled corticosteroid
Other Names:
  • Arnuity
Placebo Comparator: Matching Placebo

Daily inhalation of inactive placebo comparator for 7 days Response to methacholine induced bronchoconstriction will be assessed on Day 1 before first inhalation of study treatment (baseline) and again at 24, 72 and 168 hours.

The change in airway responsiveness to methacholine will be determined as a dose shift in methacholine PD20 from baseline to each of the three timepoints
Other: Matching placebo
Placebo inhaler

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Methacholine provocation dose causing a 20% fall in FEV1 (PD20)
Time Frame: 24 hours post dose, 72 hours post dose and 168 hours post dose
Change from baseline in airway response to inhaled methacholine following daily dosing with fluticasone furoate or placebo
24 hours post dose, 72 hours post dose and 168 hours post dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fractional exhaled nitric oxide (FeNO)
Time Frame: 168 hours
Change from baseline on levels of fractional exhaled nitric oxide
168 hours
Sputum eosinophils
Time Frame: Baseline
Assessment of induced sputum differential cell counts
Baseline

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 30, 2018

Primary Completion (Actual)

April 1, 2019

Study Completion (Actual)

April 1, 2019

Study Registration Dates

First Submitted

March 29, 2019

First Submitted That Met QC Criteria

March 29, 2019

First Posted (Actual)

April 2, 2019

Study Record Updates

Last Update Posted (Actual)

December 10, 2019

Last Update Submitted That Met QC Criteria

December 9, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bio ID 366

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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