Acute Montelukast in Asthma (AcMk)

University of East Anglia

Status and phase: Completed; Phase 4

Conditions: Acute Asthma Exacerbation

Treatments: Drug: Montelukast; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01011452

LREC 2000-108

Details and patient eligibility

About

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.

Enrollment: 87 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

87 participants in 2 patient groups, including a placebo group

Montelukast

Active Comparator group

Description:

1 study capsule at study entry Montelukast 10mg and a further study capsule at 10pm for four weeks

Treatment:

Drug: Montelukast

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo