Acute Montelukast in Asthma
Overview[ - collapse ][ - ]
Purpose | 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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Condition | Acute Asthma Exacerbation |
Intervention | Drug: Montelukast Drug: Placebo |
Phase | Phase 4 |
Sponsor | University of East Anglia |
Responsible Party | University of East Anglia |
ClinicalTrials.gov Identifier | NCT01011452 |
First Received | November 10, 2009 |
Last Updated | November 10, 2009 |
Last verified | November 2009 |
Tracking Information[ + expand ][ + ]
First Received Date | November 10, 2009 |
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Last Updated Date | November 10, 2009 |
Start Date | May 2001 |
Estimated Primary Completion Date | October 2004 |
Current Primary Outcome Measures | Difference in peak flow between active and placebo limbs by the morning after randomization [Time Frame: 24 hours maximum] [Designated as safety issue: No] |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Acute Montelukast in Asthma |
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Official Title | Assessment of the Effect of Oral Montelukast as Additional Treatment in the Management of Patients With Acute Severe Asthma. |
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 Provided |
Study Type | Interventional |
Study Phase | Phase 4 |
Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
Condition | Acute Asthma Exacerbation |
Intervention | Drug: Montelukast 1 study capsule at study entry Montelukast 10mg and a further study capsule at 10pm for four weeks Other Names: SingulairDrug: Placebo 1 placebo capsule at study entry and a further placebo capsule at 10pm for four weeks |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 87 |
Estimated Completion Date | October 2004 |
Estimated Primary Completion Date | August 2004 |
Eligibility 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 |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | United Kingdom |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01011452 |
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Other Study ID Numbers | LREC 2000-108 |
Has Data Monitoring Committee | No |
Information Provided By | University of East Anglia |
Study Sponsor | University of East Anglia |
Collaborators | Norfolk Association of Asthma Nurses Merck Sharp & Dohme Corp. |
Investigators | Not Provided |
Verification Date | November 2009 |
Locations[ + expand ][ + ]
Norfolk and Norwich University Hospital | Norwich, United Kingdom, NR47UY |
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