Acute Montelukast in Asthma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-05-31

Study Completion Date

2004-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Asthma Exacerbation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Montelukast

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

Group Type ACTIVE_COMPARATOR

Montelukast

Intervention Type DRUG

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Montelukast

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Singulair

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No