Acute Montelukast in Asthma (AcMk)

November 10, 2009 updated by: University of East Anglia

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

87

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Norwich, United Kingdom, NR47UY
        • Norfolk and Norwich University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
1 placebo capsule at study entry and a further placebo capsule at 10pm for four weeks
Active Comparator: Montelukast
1 study capsule at study entry Montelukast 10mg and a further study capsule at 10pm for four weeks
Drug: Montelukast
1 study capsule at study entry Montelukast 10mg and a further study capsule at 10pm for four weeks
Other Names:
  • Singulair

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Difference in peak flow between active and placebo limbs by the morning after randomization
Time Frame: 24 hours maximum
24 hours maximum

Secondary Outcome Measures

Outcome Measure
Time Frame
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
24 hours maximum
Time to discharge from hospital
PEF, FEV and FVC (as % best/predicted) the morning following admission and at 4 week clinic follow up
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
Proportion of days (post discharge until follow up) with a PEFR variability of greater than or equal to 25%
Residual volume as % predicted and RV/TLC% and FEF50 and FEF75 at 4 week out patient visit
requirement for further medical intervention / increases in treatment following discharge
Evaluation of quality of life over the four week out patient follow up period and expressed preference to continue on study medication
Evaluation of economic costs and savings from the additional treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of East Anglia

Collaborators

Merck Sharp & Dohme LLC
Norfolk Association of Asthma Nurses

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2001

Primary Completion (Actual)

August 1, 2004

Study Completion (Actual)

October 1, 2004

Study Registration Dates

First Submitted

November 10, 2009

First Submitted That Met QC Criteria

November 10, 2009

First Posted (Estimate)

November 11, 2009

Study Record Updates

Last Update Posted (Estimate)

November 11, 2009

Last Update Submitted That Met QC Criteria

November 10, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LREC 2000-108

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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