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Acute Montelukast in Asthma (AcMk)

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ClinicalTrials.gov Identifier: NCT01011452
Recruitment Status : Completed
First Posted : November 11, 2009
Last Update Posted : November 11, 2009
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Acute Asthma Exacerbation Drug: Montelukast Drug: Placebo Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessment of the Effect of Oral Montelukast as Additional Treatment in the Management of Patients With Acute Severe Asthma.
Study Start Date : May 2001
Primary Completion Date : August 2004
Study Completion Date : October 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Montelukast
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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 Name: Singulair
Placebo Comparator: Placebo Drug: Placebo
1 placebo capsule at study entry and a further placebo capsule at 10pm for four weeks

Outcome Measures

Primary Outcome Measures :
  1. Difference in peak flow between active and placebo limbs by the morning after randomization [ Time Frame: 24 hours maximum ]

Secondary Outcome Measures :
  1. 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 ]
  2. Time to discharge from hospital
  3. PEF, FEV and FVC (as % best/predicted) the morning following admission and at 4 week clinic follow up
  4. 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
  5. Proportion of days (post discharge until follow up) with a PEFR variability of greater than or equal to 25%
  6. Residual volume as % predicted and RV/TLC% and FEF50 and FEF75 at 4 week out patient visit
  7. requirement for further medical intervention / increases in treatment following discharge
  8. Evaluation of quality of life over the four week out patient follow up period and expressed preference to continue on study medication
  9. Evaluation of economic costs and savings from the additional treatment

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01011452

United Kingdom
Norfolk and Norwich University Hospital
Norwich, United Kingdom, NR47UY
Sponsors and Collaborators
University of East Anglia
Norfolk Association of Asthma Nurses
Merck Sharp & Dohme Corp.
More Information

Ramsay, CF., Oral Motelukast in Patients with Acute Severe Asthma. Abstract NO P3609. ERJ Sept 2007

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Crichton Ramsay, NNUH
ClinicalTrials.gov Identifier: NCT01011452     History of Changes
Other Study ID Numbers: LREC 2000-108
First Posted: November 11, 2009    Key Record Dates
Last Update Posted: November 11, 2009
Last Verified: November 2009

Keywords provided by University of East Anglia:
Acute Asthma Exacerbation
Management of acute asthma exacerbation

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action