Effect of Fluticasone Furoate on Methacholine Challenge

University of Saskatchewan

Status and phase: Completed; Phase 4

Conditions: Asthma

Treatments: Drug: Fluticasone furoate; Other: Matching placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03898466

Bio ID 366

Details and patient eligibility

About

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

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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14 participants in 2 patient groups, including a placebo group

Fluticasone Furoate

Experimental group

Description:

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

Treatment:

Drug: Fluticasone furoate

Matching Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Matching placebo