A Phase 4 interventional study of Montelukast and Placebo in Acute Asthma Exacerbation, sponsored by University of East Anglia. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2009-11-11.
Sponsored by University of East Anglia · Phase 4, Interventional, and Treatment
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.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 87 is close to the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →University of East Anglia is the lead sponsor of 73 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
1 study capsule at study entry Montelukast 10mg and a further study capsule at 10pm for four weeks
Drug: Montelukast
Drug: Placebo
1 study capsule at study entry Montelukast 10mg and a further study capsule at 10pm for four weeks
Also known as: Singulair
1 placebo capsule at study entry and a further placebo capsule at 10pm for four weeks
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
This study is completed, as verified in Nov 2009. You cannot join it, but the record below documents what was studied.
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University of East Anglia