Acute Montelukast in Asthma

Study Overview
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Brief Summary
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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.

Official Title
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Assessment of the Effect of Oral Montelukast as Additional Treatment in the Management of Patients With Acute Severe Asthma.

Conditions
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Acute Asthma Exacerbation

Intervention / Treatment
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* Drug: Montelukast
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute Asthma exacerbation requiring hospitalisation Exclusion Criteria: Smoking history greater than or equal to 10 pack years Presenting PEFR greater than or equal to 75% predicted / best Failure to demonstrate greater than or equal to 15% variability in PEFR or FEV during the study Any significant and active pulmonary pathology other than asthma Pregnancy or breastfeeding Intended pregnancy or inability to take adequate precautions against conception Patient already on Montelukast Patient already on Phenobarbitone Patient already on Rifampicin Patient already on Phenytoin Chronic airflow limitation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Montelukast<br>1 study capsule at study entry Montelukast 10mg and a further study capsule at 10pm for four weeks | Drug: Montelukast<br>* 1 study capsule at study entry Montelukast 10mg and a further study capsule at 10pm for four weeks<br>* Other names: Singulair;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 1 placebo capsule at study entry and a further placebo capsule at 10pm for four weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in peak flow between active and placebo limbs by the morning after randomization |  | 24 hours maximum | 

Secondary Outcome Measures

| Outcome Measure | 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 |  |  | 
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Asthma Exacerbation, Montelukast, Management of acute asthma exacerbation