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Add-on Salmeterol Versus Montelukast in Arg/Arg-16 Asthmatics

NCT00655616 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2011-03-24

No results posted yet for this study

Summary

The purpose of this study is to determine whether patients with asthma who carry a genotype associated with adverse outcomes with long-acting beta-2 agonists like salmeterol show greater benefit from the use of an asthma drug that works via alternative pathways like montelukast.

Conditions

Interventions

DRUG

Montelukast Placebo

Seretide 100 Accuhaler 1 dose twice daily plus 1 tablet daily of placebo montelukast Seretide 250 Accuhaler 1 dose twice daily plus 1 tablet daily of placebo montelukast Seretide 500 Accuhaler 1 dose twice daily plus 1 tablet daily of placebo montelukast Doses of montelukast or placebo: up to 6 years 4 mg once daily; 6-14 years 5 mg once daily; 15 years and above 10 mg once daily

DRUG

Salmeterol, Montelukast

Flixotide Accuhaler 50 micrograms per blister, 1 blister dose twice daily plus 1 tablet daily of montelukast Flixotide Accuhaler 100 micrograms per blister; 1 blister dose twice daily plus 1 tablet daily of montelukast Flixotide Accuhaler 250 micrograms per blister; 1 blister dose twice daily plus 1 tablet daily of montelukast Flixotide Accuhaler 500 micrograms per blister; 1 blister dose twice daily plus 1 tablet daily of montelukast Doses of montelukast or placebo: up to 6 years 4 mg once daily; 6-14 years 5 mg once daily; 15 years and above 10 mg once daily

Sponsors & Collaborators

Principal Investigators

  • Somnath Mukhopadhyay, FRCPCH,PhD · University of Dundee

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2009-08-31
Completion
2009-12-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00655616 on ClinicalTrials.gov