A Proof-of-Concept Study to evaluate the benefit from add-on therapy with montelukast versus salmeterol in children with asthma carrying the Arg/Arg-16 beta2-receptor genotype

Phase 1

• Conditions: Asthma; MedDRA version: 8.1Level: LLTClassification code 10003553Term: Asthma

• Registration Number: EUCTR2006-003264-65-GB
• Lead Sponsor: niversity of Dundee

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-08
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

All children and adolescents (5-18 years) with asthma in Tayside (Scotland) known (a) to carry the Arg/Arg-16 genotype and (b) currently on inhaled steroids and (c) inhaled bronchodilators according to need will be telephoned or contacted through home visits to establish if they have had (a) any school absences from asthma or (b) out-of-hours visits to GP/hospital visits/admissions or NHS 24 contacts due to asthma over the previous 12 months. All patients fulfilling the above inclusion criteria will be invited to participate in the study.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

The presence of serious respiratory or multi-system disease (e.g. cystic fibrosis, cancer under current treatment) will constitute exclusion criteria for the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified