Acute Montelukast in Asthma
- Registration Number
- NCT01011452
- Lead Sponsor
- University of East Anglia
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 87
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Montelukast Montelukast 1 study capsule at study entry Montelukast 10mg and a further study capsule at 10pm for four weeks
- Primary Outcome Measures
Name Time Method Difference in peak flow between active and placebo limbs by the morning after randomization 24 hours maximum
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Norfolk and Norwich University Hospital
🇬🇧Norwich, United Kingdom