Clinical trial NCT01011452: Acute Montelukast in Asthma
Official title: Assessment of the Effect of Oral Montelukast as Additional Treatment in the Management of Patients With Acute Severe Asthma.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Asthma Exacerbation
Keywords: Acute Asthma Exacerbation
Montelukast
Management of acute asthma exacerbation
Lead sponsor: University of East Anglia
Sponsor class: OTHER
Collaborators: name: Norfolk Association of Asthma Nurses
name: Merck Sharp & Dohme LLC
First posted: 2009-11-11
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Difference in peak flow between active and placebo limbs by the morning after randomization
timeFrame: 24 hours maximum
Secondary outcomes:
measure: 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
timeFrame: 24 hours maximum
measure: Time to discharge from hospital
measure: PEF, FEV and FVC (as % best/predicted) the morning following admission and at 4 week clinic follow up
measure: 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
measure: Proportion of days (post discharge until follow up) with a PEFR variability of greater than or equal to 25%
measure: Residual volume as % predicted and RV/TLC% and FEF50 and FEF75 at 4 week out patient visit
measure: requirement for further medical intervention / increases in treatment following discharge
measure: Evaluation of quality of life over the four week out patient follow up period and expressed preference to continue on study medication
measure: Evaluation of economic costs and savings from the additional treatment
Other outcomes:
Locations:
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospital
Study officials:
References:
citation: Ramsay, CF., Oral Motelukast in Patients with Acute Severe Asthma. Abstract NO P3609. ERJ Sept 2007
citation: 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.