Acute Asthma Exacerbation
Conditions
Keywords
Acute Asthma Exacerbation, Montelukast, Management of acute asthma exacerbation
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.
Interventions
DRUGMontelukast
1 study capsule at study entry Montelukast 10mg and a further study capsule at 10pm for four weeks
DRUGPlacebo
1 placebo capsule at study entry and a further placebo capsule at 10pm for four weeks
Sponsors
Norfolk Association of Asthma Nurses
Merck Sharp & Dohme LLC
University of East Anglia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in peak flow between active and placebo limbs by the morning after randomization | 24 hours maximum |
Secondary
| Measure | Time frame |
|---|---|
| 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% | — |
| 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 |
| 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 | — |
| Residual volume as % predicted and RV/TLC% and FEF50 and FEF75 at 4 week out patient visit | — |
Countries
United Kingdom
Outcome results
None listed