- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03315000
Effect of Vilanterol on Methacholine Challenge Results
The Effect of Vilanterol Against Methacholine-induced Bronchoconstriction in Mild Asthmatics
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Saskatchewan
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Saskatoon, Saskatchewan, Canada, S7N 0W8
- Asthma Research Lab - University of Saskatchewan
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Vilanterol
Vilanterol (25mcg)+ fluticasone (100mcg) inhaled through Ellipta® inhaler
|
Same as vilanterol arm description
Other Names:
|
Experimental: Fluticasone
Fluticasone (100mcg) monotherapy inhaled through Ellipta® inhaler
|
Same as fluticasone arm description
Other Names:
|
Placebo Comparator: Placebo
Lactose powder inhaled through Ellipta® inhaler
|
Same as placebo arm description
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline methacholine PC20 (bronchoprotection) at 30 min post-treatment
Time Frame: baseline versus 30 min post-treatment
|
assessed by dose shift of geometric mean methacholine PC20 data
|
baseline versus 30 min post-treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline methacholine PC20 (bronchoprotection) at 24 hours post-treatment
Time Frame: baseline versus 24 hours post-treatment
|
assessed by dose shift of geometric mean methacholine PC20 data
|
baseline versus 24 hours post-treatment
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VIL-2017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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