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OpenTrials
Completed

NCT Number: NCT01011452

Acute Montelukast in 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.

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Key information

Conditions

Acute Asthma Exacerbation

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Norfolk and Norwich University Hospital

Norwich, NR47UY, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Montelukast

Drug

1 study capsule at study entry Montelukast 10mg and a further study capsule at 10pm for four weeks

Other names: Singulair

Placebo

Drug

1 placebo capsule at study entry and a further placebo capsule at 10pm for four weeks

Primary outcomes

  1. Difference in peak flow between active and placebo limbs by the morning after randomization

    Time frame: 24 hours maximum

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of East Anglia

Other

Collaborators

  • Merck Sharp & Dohme LLC
  • Norfolk Association of Asthma Nurses

Registry information

Official study title

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

Acronym: AcMk

Important dates

Study start
2001
Primary completion
2004
Study completion
2004
First posted
Nov 11, 2009
Registry last updated
Nov 11, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.