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| Name | Class |
|---|---|
| Norfolk Association of Asthma Nurses | UNKNOWN |
| Merck Sharp & Dohme LLC | INDUSTRY |
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Patients presenting to hospital with an acute asthma exacerbation severe enough to require admission would receive full standard treatment according to British Thoracic Society guidelines in addition they would be offered the opportunity to take part in the study which would requite them to take a capsule of either montelukast or placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Montelukast | Active Comparator | 1 study capsule at study entry Montelukast 10mg and a further study capsule at 10pm for four weeks |
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| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Montelukast | Drug | 1 study capsule at study entry Montelukast 10mg and a further study capsule at 10pm for four weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in peak flow between active and placebo limbs by the morning after randomization | 24 hours maximum |
| Measure | Description | Time Frame |
|---|---|---|
| Time (hours) to achieve PEF and FEV greater than or equal to 75% best achieved in the last 12 months with greater than or equal to 25% diurnal variation | 24 hours maximum | |
| Time to discharge from hospital |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Norfolk and Norwich University Hospital | Norwich | NR47UY | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Ramsay, CF., Oral Motelukast in Patients with Acute Severe Asthma. Abstract NO P3609. ERJ Sept 2007 | ||
| 20956393 | Derived | Ramsay CF, Pearson D, Mildenhall S, Wilson AM. Oral montelukast in acute asthma exacerbations: a randomised, double-blind, placebo-controlled trial. Thorax. 2011 Jan;66(1):7-11. doi: 10.1136/thx.2010.135038. Epub 2010 Oct 18. |
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| ID | Term |
|---|---|
| C093875 | montelukast |
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| Placebo | Drug | 1 placebo capsule at study entry and a further placebo capsule at 10pm for four weeks |
|
| PEF, FEV and FVC (as % best/predicted) the morning following admission and at 4 week clinic follow up |
| Proportion of days (post discharge until follow up) with a PEFR of less than or equal to 75%, and less than or equal to 50% best predicted |
| Proportion of days (post discharge until follow up) with a PEFR variability of greater than or equal to 25% |
| Residual volume as % predicted and RV/TLC% and FEF50 and FEF75 at 4 week out patient visit |
| requirement for further medical intervention / increases in treatment following discharge |
| Evaluation of quality of life over the four week out patient follow up period and expressed preference to continue on study medication |
| Evaluation of economic costs and savings from the additional treatment |