Acute Montelukast in Asthma (AcMk)

This study has been completed.
Sponsor:
Collaborators:
Norfolk Association of Asthma Nurses
Merck Sharp & Dohme Corp.
Information provided by:
University of East Anglia
ClinicalTrials.gov Identifier:
NCT01011452
First received: November 10, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
  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.


Condition Intervention Phase
Acute Asthma Exacerbation
Drug: Montelukast
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


Further study details as provided by University of East Anglia:

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 ]

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 ]

Enrollment: 87
Study Start Date: May 2001
Study Completion Date: October 2004
Primary Completion Date: August 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01011452

Locations
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

No publications provided by University of East Anglia

Additional 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
Study First Received: November 10, 2009
Last Updated: November 10, 2009
Health Authority: United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

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

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Montelukast
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014