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Pediatric ADVAIR DISKUS Versus Oral Montelukast Chewable Tablets

NCT00328718 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 526

Last updated 2017-01-20

No results posted yet for this study

Summary

This study is being conducted to demonstrate the superior clinical effectiveness of Salmeterol/Fluticasone Propionate compared to montelukast in the management of persistent asthma in children aged 6-14 years, and to assess the effect of each treatment \[Salmeterol/Fluticasone Propionate (50/100 mcg) and montelukast (5 mg)\] on lung function, asthma control, Health Outcomes including the child's quality of life as measured by Paediatric Asthma Quality of Life Questionnaire (PAQLQ) and the caregiver's quality of life as measured by Paediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) at selected centers where a valid translation is available.

Conditions

Interventions

DRUG

montelukast (5mg QD)

DRUG

Salmeterol/Fluticasone propionate Inhalation Powder (50/100mcg BID)

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2007-04-30
Completion
2007-04-30

Countries

  • Argentina
  • Colombia
  • Costa Rica
  • Mexico
  • Peru
  • Turkey (Türkiye)
  • Venezuela

Study Locations

More Related Trials

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 NCT00328718 on ClinicalTrials.gov