Trial | NCT01011452  Report issue

Title

Acute Montelukast in Asthma
Assessment of the Effect of Oral Montelukast as Additional Treatment in the Management of Patients With Acute Severe Asthma.

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    montelukast ...

  • Study Participants

    87
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.
Study Started
May 31
2001
Primary Completion
Aug 31
2004
Study Completion
Oct 31
2004
Last Update
Nov 11
2009
Estimate

Drug Montelukast

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

  • Other names: Singulair

Drug Placebo

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

Montelukast Active Comparator

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

Placebo Placebo Comparator

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
No Results Posted