Effect of Vilanterol on Methacholine Challenge Results

Asthma Clinical Trial

Official title:

The Effect of Vilanterol Against Methacholine-induced Bronchoconstriction in Mild Asthmatics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03315000
• Other study ID #: VIL-2017
• Status: Completed
• Phase: Phase 4
• Start date: October 13, 2017
• Est. completion date: May 1, 2018

Study information

• Verified date: October 2018
• Source: University of Saskatchewan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study will assess the degree of bronchoprotection provided by the ultra long-acting beta2 agonist vilanterol against methacholine-induced bronchoconstriction.

Description:

This will be a double-blind, three-way crossover study comparing combination vilanterol+fluticasone with fluticasone monotherapy and a placebo (vilanterol is not available as a monotherapy). The order in which the treatments are given will be randomized and each treatment will be separated by a minimum one-week washout. Fifteen asthmatic participants will be recruited from the local community. Methacholine challenge testing (MCT) with the two-minute tidal breathing protocol will be used to quantify the bronchoprotective effects (if any) of each treatment against methacholine-induced bronchoconstriction.

Each participant will undergo a total of nine methacholine challenges. After a baseline methacholine challenge, the randomized treatment (identity unknown to investigator or participant) will be administered through an Ellipta® (multi-dose dry powder inhaler). Thirty minutes following treatment administration, a second methacholine challenge will be performed. At 24 hours post-treatment, each participant must re-visit the lab for one methacholine challenge. The same process will be followed for each treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: May 1, 2018
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• men and women aged 18 or older

• stable mild-to-moderate asthma

• baseline methacholine PC20 less than or equal to 8mg/mL

• FEV1 greater than or equal to 65% of predicted

Exclusion Criteria:

• Use of long-acting anticholinergic or long-acting beta2 agonist within 30 days of study

• pregnant or nursing

• diabetes

• hypokalemia

• cardiovascular, prostate, kidney, or urinary retention problems

• lactose-intolerant

• allergy-induced asthma symptoms or upper respiratory tract infection within four weeks of study

• current smokers

• past smokers with smoking history >10 pack years

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Vilanterol and Fluticasone Furoate
Same as vilanterol arm description
• Fluticasone Furoate
Same as fluticasone arm description
• Placebos
Same as placebo arm description

Locations

Country	Name	City	State
Canada	Asthma Research Lab - University of Saskatchewan	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	Change from baseline methacholine PC20 (bronchoprotection) at 30 min post-treatment	assessed by dose shift of geometric mean methacholine PC20 data	baseline versus 30 min post-treatment
Secondary	Change from baseline methacholine PC20 (bronchoprotection) at 24 hours post-treatment	assessed by dose shift of geometric mean methacholine PC20 data	baseline versus 24 hours post-treatment