NCT01011452

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2001

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2001

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2004

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2004

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

November 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 11, 2009

Completed
Last Updated

November 11, 2009

Status Verified

November 1, 2009

Enrollment Period

3.3 years

First QC Date

November 10, 2009

Last Update Submit

November 10, 2009

Conditions

Acute Asthma Exacerbation

Keywords

Acute Asthma ExacerbationMontelukastManagement of acute asthma exacerbation

Outcome Measures

Primary Outcomes (1)

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

    24 hours maximum

Secondary Outcomes (9)

  • 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

    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%

  • +4 more secondary outcomes

Study Arms (2)

Montelukast

ACTIVE COMPARATOR

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

Drug: Montelukast

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

MontelukastDRUG

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

Also known as: Singulair
Montelukast
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Acute Asthma exacerbation requiring hospitalisation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norfolk and Norwich University Hospital

Norwich, NR47UY, United Kingdom

Location

Related Publications (2)

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

    RESULT

  • 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. doi: 10.1136/thx.2010.135038. Epub 2010 Oct 18.

    PMID: 20956393DERIVED

MeSH Terms

Interventions

montelukast

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 10, 2009

First Posted

November 11, 2009

Study Start

May 1, 2001

Primary Completion

August 1, 2004

Study Completion

October 1, 2004

Last Updated

November 11, 2009

Record last verified: 2009-11

Locations

GB(1)