Viapaed Study In Children And Adolescents With Asthma

By Clinical Trial - U.S. National Library of Medicine

Apr 21, 2006, 07:07

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Viapaed Study In Children And Adolescents With Asthma

This study is currently recruiting patients.
Verified by GlaxoSmithKline April 2006

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00315744

Purpose

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 paediatric 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 �g fluticasone (FP) twice daily shall be randomised to receive the salmeterol/ fluticasone combination product, Viani (SERETIDE) 50/100 �g, or fluticasone 200 �g as a comparator drug, inhaled twice daily via the DISKUS for a period of eight weeks.

Condition	Intervention	Phase
Asthma	Drug: SERETIDE Drug: Salmeterol Drug: Fluticasone propionate	Phase IV

MedlinePlus related topics: Asthma

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

Official Title: Steroid-Sparing Management of the Salmeterol/Fluticasone 50/100�g b.i.d. Combination Compared to Fluticasone 200�g b.i.d. in Children and Adolescents With Moderate Asthma

Further study details as provided by GlaxoSmithKline:

Primary Outcomes: PEF mean morning
Secondary Outcomes: Asthma symptom score (day/night 0-4).; Number of calendar days (24 h) without symptoms.; Use of rescue medication (salbutamol).; Number of well controlled asthma weeks.; Change in mean morning PEF (% predicted).
Expected Total Enrollment: 380

Study start: September 2004

Eligibility

Ages Eligible for Study: 4 Years - 16 Years, Genders Eligible for Study: Both

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 �g/day or equivalent during the last 4 weeks before run-in.
15 minutes after inhaling 200�g 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 100�g 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.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier NCT00315744

Germany
GSK Clinical Trials Call Center, Forchheim, 91301, Germany; Recruiting