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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vilanterol | Experimental | Vilanterol (25mcg)+ fluticasone (100mcg) inhaled through Ellipta® inhaler |
|
| Fluticasone | Experimental | Fluticasone (100mcg) monotherapy inhaled through Ellipta® inhaler |
|
| Placebo | Placebo Comparator | Lactose powder inhaled through Ellipta® inhaler |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vilanterol and Fluticasone Furoate | Drug | Same as vilanterol arm description |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Don Cockcroft, MD | University of Saskatchewan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asthma Research Lab - University of Saskatchewan | Saskatoon | Saskatchewan | S7N 0W8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30017826 | Derived | Westbury GLM, Blais CM, Davis BE, Cockcroft DW. Bronchoprotective effect of vilanterol against methacholine-induced bronchoconstriction in mild asthmatics: A randomized three-way crossover study. Ann Allergy Asthma Immunol. 2018 Sep;121(3):328-332. doi: 10.1016/j.anai.2018.07.005. Epub 2018 Jul 12. |
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Journal Publication
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D012130 | Respiratory Hypersensitivity |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C550468 | vilanterol |
| C523187 | fluticasone furoate |
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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| Fluticasone Furoate | Drug | Same as fluticasone arm description |
|
|
| Placebos | Drug | Same as placebo arm description |
|
|
| D006969 |
| Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |