Effect of Fluticasone Furoate on Methacholine Challenge

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03898466
• Other study ID #: Bio ID 366
• Status: Completed
• Phase: Phase 4
• Start date: October 30, 2018
• Est. completion date: April 1, 2019

Study information

• Verified date: December 2019
• Source: University of Saskatchewan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: April 1, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Fluticasone furoate
Inhaled corticosteroid

Other:
• Matching placebo
Placebo inhaler

Locations

Country	Name	City	State
Canada	Asthma Research Lab University of Saskatchewan Room 346 Ellis Hall	Saskatoon	Saskatchewan

Sponsors (1)

Lead Sponsor	Collaborator
University of Saskatchewan

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Fractional exhaled nitric oxide (FeNO)	Change from baseline on levels of fractional exhaled nitric oxide	168 hours
Secondary	Sputum eosinophils	Assessment of induced sputum differential cell counts	Baseline