MedTrace Logo

Viapaed Study In Children And Adolescents With Asthma

NCT00315744 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 285

Last updated 2017-10-19

No results posted yet for this study

Summary

Asthmatic children who remain symptomatic on inhaled corticosteroids (ICS) require an adjustment of their asthma therapy. Current guidelines suggest that the treatment options are either an increased dose of inhaled corticosteroid or the addition of other therapy such as a long-acting beta-agonist (LABA). In the pediatric age range, major concerns with respect to high dose ICS therapy are growth retardation and the suppression of the hypothalamic-pituitary-adrenocortical (HPA) axis. Previous studies in adults have shown that a combination product that included a LABA as well as the ICS allowed to reduce the steroid dose and was still at least as effective in achieving asthma control as treatment with a higher dose of ICS. These treatment options shall be compared in the present study. Children who remain symptomatic while inhaling 100 µg fluticasone (FP) twice daily shall be randomized to receive the salmeterol/ fluticasone combination product, Viani (SERETIDE) 50/100 µg, or fluticasone 200 µg as a comparator drug, inhaled twice daily via the DISKUS for a period of eight weeks.

Conditions

Interventions

DRUG

Salmeterol/fluticasone

Salmeterol/ fluticasone are a type of long acting beta-agonist (LABA). Salmeterol 50 microgram/ fluticasone 100 microgram combination will be administered to eligible subjects via inhalation route.

DRUG

Fluticasone propionate

Fluticasone propionate is a type of LABA. Fluticasone 100 microgram dose will be administered to eligible subjects via inhalation route.

DRUG

Salbutamol

Salbutamol metered dose inhaler will be provided to all subjects as a rescue medication.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-11-04
Primary Completion
2007-04-12
Completion
2007-04-12

Countries

  • Germany

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 NCT00315744 on ClinicalTrials.gov