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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
87
1 study capsule at study entry Montelukast 10mg and a further study capsule at 10pm for four weeks
1 placebo capsule at study entry and a further placebo capsule at 10pm for four weeks
Norfolk and Norwich University Hospital
Norwich, United Kingdom
Difference in peak flow between active and placebo limbs by the morning after randomization
Time frame: 24 hours maximum
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
Time frame: 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
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