Viapaed Study In Children And Adolescents With Asthma
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
1 other identifier
interventional
285
1 country
98
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 asthma
Started Nov 2004
Typical duration for phase_4 asthma
98 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 4, 2004
CompletedFirst Submitted
Initial submission to the registry
April 17, 2006
CompletedFirst Posted
Study publicly available on registry
April 19, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 12, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
April 12, 2007
CompletedOctober 19, 2017
October 1, 2017
2.4 years
April 17, 2006
October 18, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline in mean morning peak expiratory flow (PEF)
The PEF is a person's maximum speed of expiration. PEF will be measured using a mini wright peak flow meter and will be documented daily at morning in the diary of subjects
Baseline up to Week 8
Secondary Outcomes (11)
Daily Asthma symptom score
Up to Week 8
Number of calendar days without asthma symptoms
Up to Week 8
Number of necessary administrations of salbutamol
Up to Week 8
Number of weeks with good asthma control
Up to Week 8
Change in forced vital capacity (FVC) in % of reference value
Up to Week 8
- +6 more secondary outcomes
Study Arms (2)
Subjects receiving salmeterol/fluticasone
EXPERIMENTALEligible subjects will receive 60 individual doses of the salmeterol 50 microgram/ fluticasone 100 microgram combination. Subjects will also receive placebo.
Subjects receiving fluticasone
ACTIVE COMPARATOREligible subjects will receive 60 individual fluticasone 100 microgram doses each.
Interventions
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.
Fluticasone propionate is a type of LABA. Fluticasone 100 microgram dose will be administered to eligible subjects via inhalation route.
Salbutamol metered dose inhaler will be provided to all subjects as a rescue medication.
Eligibility Criteria
You may qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (98)
GSK Investigational Site
Bad Krozingen, Baden-Wurttemberg, 79189, Germany
GSK Investigational Site
Bönnigheim, Baden-Wurttemberg, 74357, Germany
GSK Investigational Site
Ettenheim, Baden-Wurttemberg, 77955, Germany
GSK Investigational Site
Heidelberg, Baden-Wurttemberg, 69115, Germany
GSK Investigational Site
Kehl, Baden-Wurttemberg, 77694, Germany
GSK Investigational Site
Konstanz, Baden-Wurttemberg, 78464, Germany
GSK Investigational Site
Mannheim, Baden-Wurttemberg, 68167, Germany
GSK Investigational Site
Pfullendorf, Baden-Wurttemberg, 88630, Germany
GSK Investigational Site
Schwäbisch Hall, Baden-Wurttemberg, 74523, Germany
GSK Investigational Site
Schwetzingen, Baden-Wurttemberg, 68723, Germany
GSK Investigational Site
Sinsheim, Baden-Wurttemberg, 74889, Germany
GSK Investigational Site
Stuttgart, Baden-Wurttemberg, 70469, Germany
GSK Investigational Site
Stuttgart, Baden-Wurttemberg, 70499, Germany
GSK Investigational Site
Tauberbischofsheim, Baden-Wurttemberg, 97941, Germany
GSK Investigational Site
Tuttlingen, Baden-Wurttemberg, 78532, Germany
GSK Investigational Site
Villingen-Schwenningen, Baden-Wurttemberg, 78056, Germany
GSK Investigational Site
Welzheim, Baden-Wurttemberg, 73642, Germany
GSK Investigational Site
Bobingen, Bavaria, 86399, Germany
GSK Investigational Site
Forchheim, Bavaria, 91301, Germany
GSK Investigational Site
Freising, Bavaria, 85354, Germany
GSK Investigational Site
Kaufbeuren, Bavaria, 87600, Germany
GSK Investigational Site
Lauf, Bavaria, 91207, Germany
GSK Investigational Site
Munich, Bavaria, 80337, Germany
GSK Investigational Site
Munich, Bavaria, 80939, Germany
GSK Investigational Site
Munich, Bavaria, 81241, Germany
GSK Investigational Site
Nördlingen, Bavaria, 86720, Germany
GSK Investigational Site
Nuremberg, Bavaria, 90449, Germany
GSK Investigational Site
Nuremberg, Bavaria, 90473, Germany
GSK Investigational Site
Olching, Bavaria, 82140, Germany
GSK Investigational Site
Pegnitz, Bavaria, 91257, Germany
GSK Investigational Site
Rosenheim, Bavaria, 83026, Germany
GSK Investigational Site
Frankfurt (Oder), Brandenburg, 15236, Germany
GSK Investigational Site
Schwedt, Brandenburg, 16303, Germany
GSK Investigational Site
Braunfels, Hesse, 35619, Germany
GSK Investigational Site
Frankfurt am Main, Hesse, 60316, Germany
GSK Investigational Site
Kassel, Hesse, 34121, Germany
GSK Investigational Site
Niedernhausen, Hesse, 65527, Germany
GSK Investigational Site
Wetzlar, Hesse, 35576, Germany
GSK Investigational Site
Wiesbaden, Hesse, 65205, Germany
GSK Investigational Site
Belm, Lower Saxony, 49191, Germany
GSK Investigational Site
Hanover, Lower Saxony, 30625, Germany
GSK Investigational Site
Lüneburg, Lower Saxony, 21339, Germany
GSK Investigational Site
Osnabrück, Lower Saxony, 49082, Germany
GSK Investigational Site
Aachen, North Rhine-Westphalia, 52072, Germany
GSK Investigational Site
Bielefeld, North Rhine-Westphalia, 33617, Germany
GSK Investigational Site
Bochum, North Rhine-Westphalia, 44789, Germany
GSK Investigational Site
Bochum, North Rhine-Westphalia, 44791, Germany
GSK Investigational Site
Bochum, North Rhine-Westphalia, 44795, Germany
GSK Investigational Site
Bochum, North Rhine-Westphalia, 44866, Germany
GSK Investigational Site
Bottrop, North Rhine-Westphalia, 46242, Germany
GSK Investigational Site
Detmold, North Rhine-Westphalia, 32756, Germany
GSK Investigational Site
Dortmund, North Rhine-Westphalia, 44137, Germany
GSK Investigational Site
Duisburg, North Rhine-Westphalia, 47137, Germany
GSK Investigational Site
Düsseldorf, North Rhine-Westphalia, 40225, Germany
GSK Investigational Site
Düsseldorf, North Rhine-Westphalia, 40599, Germany
GSK Investigational Site
Essen, North Rhine-Westphalia, 45122, Germany
GSK Investigational Site
Euskirchen, North Rhine-Westphalia, 53879, Germany
GSK Investigational Site
Gütersloh, North Rhine-Westphalia, 33332, Germany
GSK Investigational Site
Halle, North Rhine-Westphalia, 33790, Germany
GSK Investigational Site
Kempen, North Rhine-Westphalia, 47906, Germany
GSK Investigational Site
Kleve-Materborn, North Rhine-Westphalia, 47533, Germany
GSK Investigational Site
Krefeld, North Rhine-Westphalia, 47389, Germany
GSK Investigational Site
Minden, North Rhine-Westphalia, 32427, Germany
GSK Investigational Site
Neuss, North Rhine-Westphalia, 41462, Germany
GSK Investigational Site
Neuss, North Rhine-Westphalia, 41469, Germany
GSK Investigational Site
Oberhausen, North Rhine-Westphalia, 46145, Germany
GSK Investigational Site
Remscheid, North Rhine-Westphalia, 42899, Germany
GSK Investigational Site
Wesel, North Rhine-Westphalia, 46483, Germany
GSK Investigational Site
Willich, North Rhine-Westphalia, 47877, Germany
GSK Investigational Site
Koblenz, Rhineland-Palatinate, 56068, Germany
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55127, Germany
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55131, Germany
GSK Investigational Site
Trier, Rhineland-Palatinate, 54294, Germany
GSK Investigational Site
Cossebaude, Saxony, 01462, Germany
GSK Investigational Site
Döbeln, Saxony, 04720, Germany
GSK Investigational Site
Dresden, Saxony, 01067, Germany
GSK Investigational Site
Dresden, Saxony, 01169, Germany
GSK Investigational Site
Leipzig, Saxony, 04279, Germany
GSK Investigational Site
Leipzig, Saxony, 04317, Germany
GSK Investigational Site
Wurzen, Saxony, 04808, Germany
GSK Investigational Site
Flensburg, Schleswig-Holstein, 24944, Germany
GSK Investigational Site
Geesthacht, Schleswig-Holstein, 21502, Germany
GSK Investigational Site
Harrislee, Schleswig-Holstein, 24955, Germany
GSK Investigational Site
Friedrichsfelde, State of Berlin, 10315, Germany
GSK Investigational Site
Neuhaus am Rennweg, Thuringia, 98724, Germany
GSK Investigational Site
Berlin, 10365, Germany
GSK Investigational Site
Berlin, 10785, Germany
GSK Investigational Site
Berlin, 10965, Germany
GSK Investigational Site
Berlin, 10967, Germany
GSK Investigational Site
Berlin, 10997, Germany
GSK Investigational Site
Berlin, 12161, Germany
GSK Investigational Site
Berlin, 12167, Germany
GSK Investigational Site
Berlin, 13055, Germany
GSK Investigational Site
Berlin, 13347, Germany
GSK Investigational Site
Berlin, 13355, Germany
GSK Investigational Site
Berlin, 14163, Germany
GSK Investigational Site
Hamburg, 22045, Germany
GSK Investigational Site
Hamburg, 22415, Germany
Related Publications (1)
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.
PMID: 19824054BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2006
First Posted
April 19, 2006
Study Start
November 4, 2004
Primary Completion
April 12, 2007
Study Completion
April 12, 2007
Last Updated
October 19, 2017
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.