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Viapaed Study In Children And Adolescents With Asthma

18 ottobre 2017 aggiornato da: GlaxoSmithKline

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

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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

285

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Germania
      • Berlin, Germania, 10967
        • GSK Investigational Site
      • Berlin, Germania, 13055
        • GSK Investigational Site
      • Berlin, Germania, 13347
        • GSK Investigational Site
      • Berlin, Germania, 10965
        • GSK Investigational Site
      • Berlin, Germania, 12167
        • GSK Investigational Site
      • Berlin, Germania, 10365
        • GSK Investigational Site
      • Berlin, Germania, 13355
        • GSK Investigational Site
      • Berlin, Germania, 10785
        • GSK Investigational Site
      • Berlin, Germania, 14163
        • GSK Investigational Site
      • Berlin, Germania, 10997
        • GSK Investigational Site
      • Berlin, Germania, 12161
        • GSK Investigational Site
      • Hamburg, Germania, 22415
        • GSK Investigational Site
      • Hamburg, Germania, 22045
        • GSK Investigational Site
    • Baden-Wuerttemberg
      • Bad Krozingen, Baden-Wuerttemberg, Germania, 79189
        • GSK Investigational Site
      • Boennigheim, Baden-Wuerttemberg, Germania, 74357
        • GSK Investigational Site
      • Ettenheim, Baden-Wuerttemberg, Germania, 77955
        • GSK Investigational Site
      • Heidelberg, Baden-Wuerttemberg, Germania, 69115
        • GSK Investigational Site
      • Kehl, Baden-Wuerttemberg, Germania, 77694
        • GSK Investigational Site
      • Konstanz, Baden-Wuerttemberg, Germania, 78464
        • GSK Investigational Site
      • Mannheim, Baden-Wuerttemberg, Germania, 68167
        • GSK Investigational Site
      • Pfullendorf, Baden-Wuerttemberg, Germania, 88630
        • GSK Investigational Site
      • Schwaebisch-Hall, Baden-Wuerttemberg, Germania, 74523
        • GSK Investigational Site
      • Schwetzingen, Baden-Wuerttemberg, Germania, 68723
        • GSK Investigational Site
      • Sinsheim, Baden-Wuerttemberg, Germania, 74889
        • GSK Investigational Site
      • Stuttgart, Baden-Wuerttemberg, Germania, 70469
        • GSK Investigational Site
      • Stuttgart, Baden-Wuerttemberg, Germania, 70499
        • GSK Investigational Site
      • Tauberbischofsheim, Baden-Wuerttemberg, Germania, 97941
        • GSK Investigational Site
      • Tuttlingen, Baden-Wuerttemberg, Germania, 78532
        • GSK Investigational Site
      • Villingen-Schwenningen, Baden-Wuerttemberg, Germania, 78056
        • GSK Investigational Site
      • Welzheim, Baden-Wuerttemberg, Germania, 73642
        • GSK Investigational Site
    • Bayern
      • Bobingen, Bayern, Germania, 86399
        • GSK Investigational Site
      • Forchheim, Bayern, Germania, 91301
        • GSK Investigational Site
      • Freising, Bayern, Germania, 85354
        • GSK Investigational Site
      • Kaufbeuren, Bayern, Germania, 87600
        • GSK Investigational Site
      • Lauf, Bayern, Germania, 91207
        • GSK Investigational Site
      • Muenchen, Bayern, Germania, 81241
        • GSK Investigational Site
      • Muenchen, Bayern, Germania, 80337
        • GSK Investigational Site
      • Muenchen, Bayern, Germania, 80939
        • GSK Investigational Site
      • Noerdlingen, Bayern, Germania, 86720
        • GSK Investigational Site
      • Nuernberg, Bayern, Germania, 90473
        • GSK Investigational Site
      • Nuernberg, Bayern, Germania, 90449
        • GSK Investigational Site
      • Olching, Bayern, Germania, 82140
        • GSK Investigational Site
      • Pegnitz, Bayern, Germania, 91257
        • GSK Investigational Site
      • Rosenheim, Bayern, Germania, 83026
        • GSK Investigational Site
    • Berlin
      • Friedrichsfelde, Berlin, Germania, 10315
        • GSK Investigational Site
    • Brandenburg
      • Frankfurt/Oder, Brandenburg, Germania, 15236
        • GSK Investigational Site
      • Schwedt, Brandenburg, Germania, 16303
        • GSK Investigational Site
    • Hessen
      • Braunfels, Hessen, Germania, 35619
        • GSK Investigational Site
      • Frankfurt, Hessen, Germania, 60316
        • GSK Investigational Site
      • Kassel, Hessen, Germania, 34121
        • GSK Investigational Site
      • Niedernhausen, Hessen, Germania, 65527
        • GSK Investigational Site
      • Wetzlar, Hessen, Germania, 35576
        • GSK Investigational Site
      • Wiesbaden, Hessen, Germania, 65205
        • GSK Investigational Site
    • Niedersachsen
      • Belm, Niedersachsen, Germania, 49191
        • GSK Investigational Site
      • Hannover, Niedersachsen, Germania, 30625
        • GSK Investigational Site
      • Lueneburg, Niedersachsen, Germania, 21339
        • GSK Investigational Site
      • Osnabrueck, Niedersachsen, Germania, 49082
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Aachen, Nordrhein-Westfalen, Germania, 52072
        • GSK Investigational Site
      • Bielefeld, Nordrhein-Westfalen, Germania, 33617
        • GSK Investigational Site
      • Bochum, Nordrhein-Westfalen, Germania, 44791
        • GSK Investigational Site
      • Bochum, Nordrhein-Westfalen, Germania, 44866
        • GSK Investigational Site
      • Bochum, Nordrhein-Westfalen, Germania, 44795
        • GSK Investigational Site
      • Bochum, Nordrhein-Westfalen, Germania, 44789
        • GSK Investigational Site
      • Bottrop, Nordrhein-Westfalen, Germania, 46242
        • GSK Investigational Site
      • Detmold, Nordrhein-Westfalen, Germania, 32756
        • GSK Investigational Site
      • Dortmund, Nordrhein-Westfalen, Germania, 44137
        • GSK Investigational Site
      • Duesseldorf, Nordrhein-Westfalen, Germania, 40225
        • GSK Investigational Site
      • Duesseldorf, Nordrhein-Westfalen, Germania, 40599
        • GSK Investigational Site
      • Duisburg, Nordrhein-Westfalen, Germania, 47137
        • GSK Investigational Site
      • Essen, Nordrhein-Westfalen, Germania, 45122
        • GSK Investigational Site
      • Euskirchen, Nordrhein-Westfalen, Germania, 53879
        • GSK Investigational Site
      • Guetersloh, Nordrhein-Westfalen, Germania, 33332
        • GSK Investigational Site
      • Halle, Nordrhein-Westfalen, Germania, 33790
        • GSK Investigational Site
      • Kempen, Nordrhein-Westfalen, Germania, 47906
        • GSK Investigational Site
      • Kleve-Materborn, Nordrhein-Westfalen, Germania, 47533
        • GSK Investigational Site
      • Krefeld, Nordrhein-Westfalen, Germania, 47389
        • GSK Investigational Site
      • Minden, Nordrhein-Westfalen, Germania, 32427
        • GSK Investigational Site
      • Neuss, Nordrhein-Westfalen, Germania, 41462
        • GSK Investigational Site
      • Neuss, Nordrhein-Westfalen, Germania, 41469
        • GSK Investigational Site
      • Oberhausen, Nordrhein-Westfalen, Germania, 46145
        • GSK Investigational Site
      • Remscheid, Nordrhein-Westfalen, Germania, 42899
        • GSK Investigational Site
      • Wesel, Nordrhein-Westfalen, Germania, 46483
        • GSK Investigational Site
      • Willich, Nordrhein-Westfalen, Germania, 47877
        • GSK Investigational Site
    • Rheinland-Pfalz
      • Koblenz, Rheinland-Pfalz, Germania, 56068
        • GSK Investigational Site
      • Mainz, Rheinland-Pfalz, Germania, 55131
        • GSK Investigational Site
      • Mainz, Rheinland-Pfalz, Germania, 55127
        • GSK Investigational Site
      • Trier, Rheinland-Pfalz, Germania, 54294
        • GSK Investigational Site
    • Sachsen
      • Cossebaude, Sachsen, Germania, 01462
        • GSK Investigational Site
      • Doebeln, Sachsen, Germania, 04720
        • GSK Investigational Site
      • Dresden, Sachsen, Germania, 01067
        • GSK Investigational Site
      • Dresden, Sachsen, Germania, 01169
        • GSK Investigational Site
      • Leipzig, Sachsen, Germania, 04317
        • GSK Investigational Site
      • Leipzig, Sachsen, Germania, 04279
        • GSK Investigational Site
      • Wurzen, Sachsen, Germania, 04808
        • GSK Investigational Site
    • Schleswig-Holstein
      • Flensburg, Schleswig-Holstein, Germania, 24944
        • GSK Investigational Site
      • Geesthacht, Schleswig-Holstein, Germania, 21502
        • GSK Investigational Site
      • Harrislee, Schleswig-Holstein, Germania, 24955
        • GSK Investigational Site
    • Thueringen
      • Neuhaus am Rennweg, Thueringen, Germania, 98724
        • GSK Investigational Site

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 4 anni a 16 anni (Bambino)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Subjects receiving salmeterol/fluticasone
Eligible subjects will receive 60 individual doses of the salmeterol 50 microgram/ fluticasone 100 microgram combination. Subjects will also receive placebo.
Droga: 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.
Droga: Salbutamol
Salbutamol metered dose inhaler will be provided to all subjects as a rescue medication.
Comparatore attivo: Subjects receiving fluticasone
Eligible subjects will receive 60 individual fluticasone 100 microgram doses each.
Droga: Salbutamol
Salbutamol metered dose inhaler will be provided to all subjects as a rescue medication.
Droga: Fluticasone propionate
Fluticasone propionate is a type of LABA. Fluticasone 100 microgram dose will be administered to eligible subjects via inhalation route.
Altri nomi:
  • SERETIDE
  • Salmeterolo

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from Baseline in mean morning peak expiratory flow (PEF)
Lasso di tempo: Baseline up to Week 8
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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Daily Asthma symptom score
Lasso di tempo: Up to Week 8
Asthma symptoms will be recorded separately for night and day using 2 symptom scores. Symptoms included will be coughing, wheezing, shortness of breath, feeling of tightness in the chest and nocturnal waking due to 1 or more of these symptoms. Score will range from 0-4 where 0 = no complaints and 4= person could not sleep due to asthma symptoms.
Up to Week 8
Number of calendar days without asthma symptoms
Lasso di tempo: Up to Week 8
Number of calendar days without asthma symptoms will be defined as the sum of all days for which the patient documented an asthma symptom score of 0 (no complaints) for the day and the previous night.
Up to Week 8
Number of necessary administrations of salbutamol
Lasso di tempo: Up to Week 8
The number of necessary administrations of salbutamol will be documented daily by subjects in the diary.
Up to Week 8
Number of weeks with good asthma control
Lasso di tempo: Up to Week 8
One week of well controlled asthma will be defined by fulfilling the following criteria: at least 2 of the following criteria (type A): symptoms with a symptom score >1 on at most 2 days, use of rescue medication maximally 4 x per week, morning PEF daily >=80% of the predicted normal value and all the following criteria (type B): no nocturnal waking due to bronchial asthma, no exacerbations, no out-patient or hospitalized emergency treatment due to asthma, no adverse events due to administration of the study medication which would have necessitated a change of treatment, no intolerance or refusal of study medication
Up to Week 8
Change in forced vital capacity (FVC) in % of reference value
Lasso di tempo: Up to Week 8
FVC is the amount of air which can be forcibly exhaled from the lungs after taking the deep breath.
Up to Week 8
Change in forced expiratory volume in 1 second (FEV1) in % of reference value
Lasso di tempo: Up to Week 8
FEV1 is the volume of air exhaled under forced conditions in 1 second.
Up to Week 8
Change in peak expiratory flow rate (PEFR) in % of reference value
Lasso di tempo: Up to Week 8
PEFR is a person's maximum speed of expiration.
Up to Week 8
Change in mean morning peak flow in % of reference value
Lasso di tempo: Up to Week 8
The PEF is a person's maximum speed of expiration. PEF will be measured using a mini wright peak flow meter
Up to Week 8
Percentage of subjects with a peak flow variability of 20%
Lasso di tempo: Up to Week 8
Morning versus evening peak flow will be calculated and compared.
Up to Week 8
Number of subject withdrawals due to asthma exacerbations
Lasso di tempo: Up to Week 8
Asthma exacerbations are acute or sub acute episodes, which are characterized by a progressive increase in one or more typical asthma symptoms.
Up to Week 8
Number of subjects with adverse events (AEs)
Lasso di tempo: Up to Week 8
An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Up to Week 8

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

GlaxoSmithKline

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

4 novembre 2004

Completamento primario (Effettivo)

12 aprile 2007

Completamento dello studio (Effettivo)

12 aprile 2007

Date di iscrizione allo studio

Primo inviato

17 aprile 2006

Primo inviato che soddisfa i criteri di controllo qualità

17 aprile 2006

Primo Inserito (Stima)

19 aprile 2006

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

19 ottobre 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

18 ottobre 2017

Ultimo verificato

1 ottobre 2017

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 102318

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Dati/documenti di studio

  1. Specifica del set di dati
    Identificatore informazioni: 102318
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  2. Piano di analisi statistica
    Identificatore informazioni: 102318
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  3. Set di dati del singolo partecipante
    Identificatore informazioni: 102318
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  4. Modulo di consenso informato
    Identificatore informazioni: 102318
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  5. Protocollo di studio
    Identificatore informazioni: 102318
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  6. Rapporto di studio clinico
    Identificatore informazioni: 102318
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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