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The study will determine the effect of inhaled fluticasone furoate on airway responsiveness to methacholine in mild asthmatics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluticasone Furoate | Experimental | Daily inhalation of 100mcg fluticasone furoate for 7 days Response to methacholine induced bronchoconstriction will be assessed on Day 1 before first inhalation of study treatment (baseline) and again at 24, 72 and 168 hours. The change in airway responsiveness to methacholine will be determined as a dose shift in methacholine PD20 from baseline to each of the three timepoints |
|
| Matching Placebo | Placebo Comparator | Daily inhalation of inactive placebo comparator for 7 days Response to methacholine induced bronchoconstriction will be assessed on Day 1 before first inhalation of study treatment (baseline) and again at 24, 72 and 168 hours. The change in airway responsiveness to methacholine will be determined as a dose shift in methacholine PD20 from baseline to each of the three timepoints |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluticasone furoate | Drug | Inhaled corticosteroid |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Fractional exhaled nitric oxide (FeNO) | Change from baseline on levels of fractional exhaled nitric oxide | 168 hours |
| Sputum eosinophils | Assessment of induced sputum differential cell counts |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asthma Research Lab University of Saskatchewan Room 346 Ellis Hall | Saskatoon | Saskatchewan | S7N 0W8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31434037 | Derived | Okonkwo CS, Davis BE, Blais CM, Cockcroft DW. Short-term effect of once-daily fluticasone furoate on methacholine-induced bronchoconstriction in mild asthmatics. Respir Med. 2019 Sep;156:53-57. doi: 10.1016/j.rmed.2019.08.007. Epub 2019 Aug 13. |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C523187 | fluticasone furoate |
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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| Matching placebo | Other | Placebo inhaler |
|
| Baseline |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |