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Completed

NCT Number: NCT03898466

Effect of Fluticasone Furoate on Methacholine Challenge

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

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Asthma Research Lab University of Saskatchewan Room 346 Ellis Hall

Saskatoon, Saskatchewan, S7N 0W8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluticasone Furoate

Drug

Inhaled corticosteroid

Other names: Arnuity

Matching Placebo

Other

Placebo inhaler

Primary outcomes

  1. 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

Secondary outcomes

  1. Fractional exhaled nitric oxide (FeNO)

    Time frame: 168 hours

    Change from baseline on levels of fractional exhaled nitric oxide

  2. Sputum eosinophils

    Time frame: Baseline

    Assessment of induced sputum differential cell counts

Sponsors and collaborators

Lead sponsor

University of Saskatchewan

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 2, 2019
Registry last updated
Dec 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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