Effect of Fluticasone Furoate on Methacholine Challenge

NCT03898466 | Completed Phase 4

• 1 other identifier: Bio ID 366
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Methacholine provocation dose causing a 20% fall in FEV1 (PD20)

  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 Outcomes (2)

• Fractional exhaled nitric oxide (FeNO)

  168 hours

• Sputum eosinophils

  Baseline

Study Arms (2)

Fluticasone Furoate

EXPERIMENTAL

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

Matching Placebo

PLACEBO COMPARATOR

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

Interventions

Fluticasone furoate DRUG

Inhaled corticosteroid

Also known as: Arnuity

Fluticasone Furoate

Matching placebo OTHER

Placebo inhaler

Matching Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Saskatchewan: lead

Study Sites (1)

Asthma Research Lab University of Saskatchewan Room 346 Ellis Hall

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

Related Publications (1)

• Okonkwo CS, Davis BE, Blais CM, Cockcroft DW. Short-term effect of once-daily fluticasone furoate on methacholine-induced bronchoconstriction in mild asthmatics. Respir Med. 2019 Sep;156:53-57. doi: 10.1016/j.rmed.2019.08.007. Epub 2019 Aug 13.

  PMID: 31434037 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

fluticasone furoate; Fluticasone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 29, 2019
• First Posted: April 2, 2019
• Study Start: October 30, 2018
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: December 10, 2019

Record last verified: 2019-12

Locations

CA (1)