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

November 10, 2009
November 10, 2009
May 2001
August 2004   (final data collection date for primary outcome measure)
Difference in peak flow between active and placebo limbs by the morning after randomization [ Time Frame: 24 hours maximum ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Acute Montelukast in Asthma
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Acute Asthma Exacerbation
  • Drug: Montelukast
    1 study capsule at study entry Montelukast 10mg and a further study capsule at 10pm for four weeks
    Other Name: Singulair
  • 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
    Intervention: Drug: Montelukast
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Ramsay CF, Pearson D, Mildenhall S, Wilson AM. Oral montelukast in acute asthma exacerbations: a randomised, double-blind, placebo-controlled trial. Thorax. 2011 Jan;66(1):7-11. Epub 2010 Oct 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
87
October 2004
August 2004   (final data collection date for primary outcome measure)

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
Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01011452
LREC 2000-108
No
Crichton Ramsay, NNUH
University of East Anglia
  • Norfolk Association of Asthma Nurses
  • Merck Sharp & Dohme Corp.
Not Provided
University of East Anglia
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP