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Viapaed Study In Children And Adolescents With Asthma

NCT ID: NCT00315744

Last Updated: 2017-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

285 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-04

Study Completion Date

2007-04-12

Brief Summary

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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.

Detailed Description

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Conditions

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Asthma

Keywords

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moderate asthma fluticasone children salmeterol steroid-sparing Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Study Groups

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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.

Group Type EXPERIMENTAL

Salmeterol/fluticasone

Intervention Type DRUG

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.

Salbutamol

Intervention Type DRUG

Salbutamol metered dose inhaler will be provided to all subjects as a rescue medication.

Subjects receiving fluticasone

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

Group Type ACTIVE_COMPARATOR

Fluticasone propionate

Intervention Type DRUG

Fluticasone propionate is a type of LABA. Fluticasone 100 microgram dose will be administered to eligible subjects via inhalation route.

Salbutamol

Intervention Type DRUG

Salbutamol metered dose inhaler will be provided to all subjects as a rescue medication.

Interventions

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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.

Intervention Type DRUG

Fluticasone propionate

Fluticasone propionate is a type of LABA. Fluticasone 100 microgram dose will be administered to eligible subjects via inhalation route.

Intervention Type DRUG

Salbutamol

Salbutamol metered dose inhaler will be provided to all subjects as a rescue medication.

Intervention Type DRUG

Other Intervention Names

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Salmeterol SERETIDE

Eligibility Criteria

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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.
Minimum Eligible Age

4 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Bad Krozingen, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Bönnigheim, Baden-Wurttemberg, Germany

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Ettenheim, Baden-Wurttemberg, Germany

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Heidelberg, Baden-Wurttemberg, Germany

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Kehl, Baden-Wurttemberg, Germany

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Konstanz, Baden-Wurttemberg, Germany

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Mannheim, Baden-Wurttemberg, Germany

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Pfullendorf, Baden-Wurttemberg, Germany

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Schwäbisch Hall, Baden-Wurttemberg, Germany

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Schwetzingen, Baden-Wurttemberg, Germany

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Sinsheim, Baden-Wurttemberg, Germany

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Stuttgart, Baden-Wurttemberg, Germany

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Stuttgart, Baden-Wurttemberg, Germany

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Tauberbischofsheim, Baden-Wurttemberg, Germany

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Tuttlingen, Baden-Wurttemberg, Germany

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Villingen-Schwenningen, Baden-Wurttemberg, Germany

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Welzheim, Baden-Wurttemberg, Germany

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Bobingen, Bavaria, Germany

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Forchheim, Bavaria, Germany

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Freising, Bavaria, Germany

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Kaufbeuren, Bavaria, Germany

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Lauf, Bavaria, Germany

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Munich, Bavaria, Germany

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Munich, Bavaria, Germany

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Munich, Bavaria, Germany

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Nördlingen, Bavaria, Germany

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Nuremberg, Bavaria, Germany

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Nuremberg, Bavaria, Germany

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Olching, Bavaria, Germany

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Pegnitz, Bavaria, Germany

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Rosenheim, Bavaria, Germany

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Frankfurt (Oder), Brandenburg, Germany

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Schwedt, Brandenburg, Germany

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Braunfels, Hesse, Germany

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Frankfurt am Main, Hesse, Germany

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Kassel, Hesse, Germany

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Niedernhausen, Hesse, Germany

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Wetzlar, Hesse, Germany

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Wiesbaden, Hesse, Germany

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Belm, Lower Saxony, Germany

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Hanover, Lower Saxony, Germany

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Lüneburg, Lower Saxony, Germany

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Osnabrück, Lower Saxony, Germany

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Aachen, North Rhine-Westphalia, Germany

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Bielefeld, North Rhine-Westphalia, Germany

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Bochum, North Rhine-Westphalia, Germany

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Bochum, North Rhine-Westphalia, Germany

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Bochum, North Rhine-Westphalia, Germany

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Bochum, North Rhine-Westphalia, Germany

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Bottrop, North Rhine-Westphalia, Germany

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Detmold, North Rhine-Westphalia, Germany

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Dortmund, North Rhine-Westphalia, Germany

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Duisburg, North Rhine-Westphalia, Germany

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Düsseldorf, North Rhine-Westphalia, Germany

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Düsseldorf, North Rhine-Westphalia, Germany

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Essen, North Rhine-Westphalia, Germany

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Euskirchen, North Rhine-Westphalia, Germany

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Gütersloh, North Rhine-Westphalia, Germany

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Halle, North Rhine-Westphalia, Germany

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Kempen, North Rhine-Westphalia, Germany

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Kleve-Materborn, North Rhine-Westphalia, Germany

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Krefeld, North Rhine-Westphalia, Germany

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Minden, North Rhine-Westphalia, Germany

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Neuss, North Rhine-Westphalia, Germany

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Neuss, North Rhine-Westphalia, Germany

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Oberhausen, North Rhine-Westphalia, Germany

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Remscheid, North Rhine-Westphalia, Germany

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Wesel, North Rhine-Westphalia, Germany

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Willich, North Rhine-Westphalia, Germany

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Koblenz, Rhineland-Palatinate, Germany

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Mainz, Rhineland-Palatinate, Germany

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Mainz, Rhineland-Palatinate, Germany

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Trier, Rhineland-Palatinate, Germany

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Cossebaude, Saxony, Germany

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Döbeln, Saxony, Germany

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Dresden, Saxony, Germany

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Dresden, Saxony, Germany

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Leipzig, Saxony, Germany

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Leipzig, Saxony, Germany

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Wurzen, Saxony, Germany

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Flensburg, Schleswig-Holstein, Germany

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Geesthacht, Schleswig-Holstein, Germany

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Harrislee, Schleswig-Holstein, Germany

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Friedrichsfelde, State of Berlin, Germany

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Neuhaus am Rennweg, Thuringia, Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Hamburg, , Germany

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Hamburg, , Germany

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Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 19824054 (View on PubMed)

Study Documents

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Document Type: Dataset Specification

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Individual Participant Data Set

View Document

Document Type: Informed Consent Form

View Document

Document Type: Study Protocol

View Document

Document Type: Clinical Study Report

View Document

Related Links

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https://www.clinicalstudydatarequest.com

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Other Identifiers

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102318

Identifier Type: -

Identifier Source: org_study_id