Acute Montelukast in Asthma

Acute Asthma Exacerbation Clinical Trial

— AcMk  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01011452
• Other study ID #: LREC 2000-108
• Status: Completed
• Phase: Phase 4
• First received: November 10, 2009
• Last updated: November 10, 2009
• Start date: May 2001
• Est. completion date: October 2004

Study information

• Verified date: November 2009
• Source: University of East Anglia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health ServiceUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: October 2004
• Est. primary completion date: August 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Asthma Exacerbation
• Asthma

Intervention

Drug:
• Montelukast
1 study capsule at study entry Montelukast 10mg and a further study capsule at 10pm for four weeks
• Placebo
1 placebo capsule at study entry and a further placebo capsule at 10pm for four weeks

Locations

Country	Name	City	State
United Kingdom	Norfolk and Norwich University Hospital	Norwich

Sponsors (3)

Lead Sponsor	Collaborator
University of East Anglia	Merck Sharp & Dohme Corp., Norfolk Association of Asthma Nurses

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in peak flow between active and placebo limbs by the morning after randomization		24 hours maximum	No
Secondary	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	No
Secondary	Time to discharge from hospital			No
Secondary	PEF, FEV and FVC (as % best/predicted) the morning following admission and at 4 week clinic follow up			No
Secondary	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			No
Secondary	Proportion of days (post discharge until follow up) with a PEFR variability of greater than or equal to 25%			No
Secondary	Residual volume as % predicted and RV/TLC% and FEF50 and FEF75 at 4 week out patient visit			No
Secondary	requirement for further medical intervention / increases in treatment following discharge			No
Secondary	Evaluation of quality of life over the four week out patient follow up period and expressed preference to continue on study medication			No
Secondary	Evaluation of economic costs and savings from the additional treatment			No