Viapaed Study In Children And Adolescents With Asthma

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 4

Conditions

Asthma

Treatments

Drug: Fluticasone propionate

Drug: Salmeterol/fluticasone

Drug: Salbutamol

Study type

Interventional

Funder types

Industry

Identifiers

NCT00315744

102318

Details and patient eligibility

About

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.

Enrollment

285 patients

Sex

All

Ages

4 to 16 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

Children aged 4 to 16 years with an established history of perennial asthma.
Subjects who are treated with an inhaled corticosteroid according to BDP (budesonide) 200-400 µg/day or equivalent during the last 4 weeks before run-in.
15 minutes after inhaling 200µg of salbutamol, reversible increase in FEV1 of at least 12% of the pre-dose value.
Willingness to substitute previous controller medication on the twice daily inhalation of fluticasone 100µg bid via DISKUS®.
Subjects/guardians who have given written informed consent to participate in the study.
Subjects /guardians who are able to understand and complete a diary record card (DRC).
Subjects who are able to use a Mini-Wright Peak Flow meter.
Sexually active female adolescents must use adequate contraception.
Willingness to refrain from any other controller medication (including anti-leukotrienes) or from regular use of short-acting beta agonists or anticholinergics during the treatment period.

Trial design

285 participants in 2 patient groups

Subjects receiving salmeterol/fluticasone

Experimental group

Description:

Eligible subjects will receive 60 individual doses of the salmeterol 50 microgram/ fluticasone 100 microgram combination. Subjects will also receive placebo.

Treatment:

Drug: Salmeterol/fluticasone

Drug: Salbutamol

Subjects receiving fluticasone

Active Comparator group

Description:

Eligible subjects will receive 60 individual fluticasone 100 microgram doses each.

Treatment:

Drug: Salbutamol

Drug: Fluticasone propionate