A Phase 4 interventional study of Vilanterol and Fluticasone Furoate and Fluticasone Furoate in Asthma, sponsored by University of Saskatchewan. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-11.
Sponsored by University of Saskatchewan · Phase 4, Interventional, and Treatment
The study will assess the degree of bronchoprotection provided by the ultra long-acting beta2 agonist vilanterol against methacholine-induced bronchoconstriction.
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.
4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.
This study's enrollment of 17 is below the median of 78 across 3,341 interventional studies indexed under Asthma.
Browse Asthma studies →University of Saskatchewan is the lead sponsor of 243 studies on the registry; 34 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Vilanterol (25mcg)+ fluticasone (100mcg) inhaled through Ellipta® inhaler
Drug: Vilanterol and Fluticasone Furoate
Fluticasone (100mcg) monotherapy inhaled through Ellipta® inhaler
Drug: Fluticasone Furoate
Lactose powder inhaled through Ellipta® inhaler
Drug: Placebos
Drug pages: Vilanterol · Fluticasone furoate
Same as vilanterol arm description
Also known as: Breo
Same as fluticasone arm description
Also known as: Arnuity
Same as placebo arm description
Also known as: lactose powder
Change from baseline methacholine PC20 (bronchoprotection) at 30 min post-treatment
assessed by dose shift of geometric mean methacholine PC20 data
Time frame: baseline versus 30 min post-treatment
Change from baseline methacholine PC20 (bronchoprotection) at 24 hours post-treatment
assessed by dose shift of geometric mean methacholine PC20 data
Time frame: baseline versus 24 hours post-treatment
Plan to share: Yes — Journal Publication
Ran from Oct 2017 to primary completion in May 2018, 6 months.
Of 90 non-industry phase 4 interventional studies under Asthma, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 41. This study's 6 months is below that.
Counting every sponsor, half of 156 studies reached it within 24 months; a quarter within 11 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Vilanterol · Fluticasone furoate