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.
ConditionAcute Asthma Exacerbation
InterventionDrug: Montelukast
Drug: Placebo
PhasePhase 4
SponsorUniversity of East Anglia
Responsible PartyUniversity of East Anglia
ClinicalTrials.gov IdentifierNCT01011452
First ReceivedNovember 10, 2009
Last UpdatedNovember 10, 2009
Last verifiedNovember 2009

Tracking Information[ + expand ][ + ]

First Received DateNovember 10, 2009
Last Updated DateNovember 10, 2009
Start DateMay 2001
Estimated Primary Completion DateOctober 2004
Current Primary Outcome MeasuresDifference 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
  • 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 [Time Frame: 24 hours maximum] [Designated as safety issue: No]
  • Time to discharge from hospital [Designated as safety issue: No]
  • PEF, FEV and FVC (as % best/predicted) the morning following admission and at 4 week clinic follow up [Designated as safety issue: No]
  • 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 [Designated as safety issue: No]
  • Proportion of days (post discharge until follow up) with a PEFR variability of greater than or equal to 25% [Designated as safety issue: No]
  • Residual volume as % predicted and RV/TLC% and FEF50 and FEF75 at 4 week out patient visit [Designated as safety issue: No]
  • requirement for further medical intervention / increases in treatment following discharge [Designated as safety issue: No]
  • Evaluation of quality of life over the four week out patient follow up period and expressed preference to continue on study medication [Designated as safety issue: No]
  • Evaluation of economic costs and savings from the additional treatment [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief TitleAcute Montelukast in Asthma
Official TitleAssessment 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 DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 4
Study DesignAllocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
ConditionAcute Asthma Exacerbation
InterventionDrug: 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)
  • Active Comparator: Montelukast
    1 study capsule at study entry Montelukast 10mg and a further study capsule at 10pm for four weeks
  • Placebo Comparator: Placebo

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment87
Estimated Completion DateOctober 2004
Estimated Primary Completion DateAugust 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
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesUnited Kingdom

Administrative Information[ + expand ][ + ]

NCT Number NCT01011452
Other Study ID NumbersLREC 2000-108
Has Data Monitoring CommitteeNo
Information Provided ByUniversity of East Anglia
Study SponsorUniversity of East Anglia
CollaboratorsNorfolk Association of Asthma Nurses
Merck Sharp & Dohme Corp.
Investigators Not Provided
Verification DateNovember 2009

Locations[ + expand ][ + ]

Norfolk and Norwich University Hospital
Norwich, United Kingdom, NR47UY