Clinical trial NCT00315744: Viapaed Study In Children And Adolescents With Asthma
Official title: Steroid-sparing Management of the Salmeterol/Fluticasone 50/100µg b.i.d. Combination Compared to Fluticasone 200µg b.i.d. in Children and Adolescents With Moderate Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: moderate asthma
fluticasone
children
salmeterol
steroid-sparing
Asthma
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-04-19
Enrollment: 285
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Change from Baseline in mean morning peak expiratory flow (PEF)
timeFrame: Baseline up to Week 8
Secondary outcomes:
measure: Daily Asthma symptom score
timeFrame: Up to Week 8
measure: Number of calendar days without asthma symptoms
timeFrame: Up to Week 8
measure: Number of necessary administrations of salbutamol
timeFrame: Up to Week 8
measure: Number of weeks with good asthma control
timeFrame: Up to Week 8
measure: Change in forced vital capacity (FVC) in % of reference value
timeFrame: Up to Week 8
measure: Change in forced expiratory volume in 1 second (FEV1) in % of reference value
timeFrame: Up to Week 8
measure: Change in peak expiratory flow rate (PEFR) in % of reference value
timeFrame: Up to Week 8
measure: Change in mean morning peak flow in % of reference value
timeFrame: Up to Week 8
measure: Percentage of subjects with a peak flow variability of 20%
timeFrame: Up to Week 8
measure: Number of subject withdrawals due to asthma exacerbations
timeFrame: Up to Week 8
measure: Number of subjects with adverse events (AEs)
timeFrame: Up to Week 8
Other outcomes:
Locations:
city: Bad Krozingen
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Boennigheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Ettenheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Heidelberg
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Kehl
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Konstanz
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Mannheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Pfullendorf
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Schwaebisch-Hall
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Schwetzingen
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Sinsheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Stuttgart
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Stuttgart
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Tauberbischofsheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Tuttlingen
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Villingen-Schwenningen
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Welzheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Bobingen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Forchheim
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Freising
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Kaufbeuren
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Lauf
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Noerdlingen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Nuernberg
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Nuernberg
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Olching
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Pegnitz
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Rosenheim
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Friedrichsfelde
country: Germany
facility: GSK Investigational Site
state: Berlin
city: Frankfurt/Oder
country: Germany
facility: GSK Investigational Site
state: Brandenburg
city: Schwedt
country: Germany
facility: GSK Investigational Site
state: Brandenburg
city: Braunfels
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Frankfurt
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Kassel
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Niedernhausen
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Wetzlar
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Wiesbaden
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Belm
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Hannover
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Lueneburg
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Osnabrueck
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Aachen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Bielefeld
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Bochum
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Bochum
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Bochum
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Bochum
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Bottrop
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Detmold
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Dortmund
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Duesseldorf
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Duesseldorf
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Duisburg
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Euskirchen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Guetersloh
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Halle
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Kempen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Kleve-Materborn
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Krefeld
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Minden
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Neuss
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Neuss
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Oberhausen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Remscheid
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Wesel
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Willich
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Koblenz
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Mainz
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Mainz
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Trier
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Cossebaude
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Doebeln
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Leipzig
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Leipzig
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Wurzen
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Flensburg
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Geesthacht
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Harrislee
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Neuhaus am Rennweg
country: Germany
facility: GSK Investigational Site
state: Thueringen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Gappa M, Zachgo W, von Berg A, Kamin W, Stern-Strater C, Steinkamp G; VIAPAED Study Group. Add-on salmeterol compared to double dose fluticasone in pediatric asthma: a double-blind, randomized trial (VIAPAED). Pediatr Pulmonol. 2009 Nov;44(11):1132-42. doi: 10.1002/ppul.21120.