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Effect of Fluticasone Furoate on Methacholine Challenge

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ClinicalTrials.gov Identifier: NCT03898466
Recruitment Status : Recruiting
First Posted : April 2, 2019
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
Don Cockcroft, University of Saskatchewan

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

Condition or disease Intervention/treatment Phase
Asthma Drug: Fluticasone furoate Other: Matching placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Once-daily Fluticasone Furoate on Methacholine-induced Bronchoconstriction in Mild Asthmatics
Actual Study Start Date : October 30, 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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 Name: 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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03898466


Locations
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Canada, Saskatchewan
Asthma Research Lab University of Saskatchewan Room 346 Ellis Hall Recruiting
Saskatoon, Saskatchewan, Canada, S7N 0W8
Contact: Beth Davis, PhD    306-844-1444    beth.davis@usask.ca   
Principal Investigator: Don Cockcroft, MD         
Sub-Investigator: Beth Davis, PhD         
Sponsors and Collaborators
University of Saskatchewan

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Responsible Party: Don Cockcroft, Professor, University of Saskatchewan
ClinicalTrials.gov Identifier: NCT03898466     History of Changes
Other Study ID Numbers: Bio ID 366
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Fluticasone
Methacholine Chloride
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Miotics
Parasympathomimetics
Bronchoconstrictor Agents
Muscarinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action