Clinical trial NCT00353873: Seretide Versus Flixotide In Asthmatic Children Not Controlled By Inhaled Corticosteroids
Official title: A Multicentre, Randomised, Double-blind, Double Dummy, Parallel Group Study to Compare the Salmeterol/Fluticasone Propionate Combination (SeretideTM) at a Dose of 50/100µg Twice Daily and Fluticasone Propionate (FlixotideTM) at a Dose of 200µg Twice Daily, Both Delivered Via a Dry Powder Inhaler (DiskusTM) for 12 Weeks in Asthma in Children Aged 4-11 Years Not Controlled by Inhaled Corticosteroids Alone at Medium Dose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: FLIXOTIDE
asthmatics children 4-11 years
SERETIDE
asthma-control
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-07-19
Enrollment: 506
Sex: ALL
Minimum age (years): 4
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare two treatment strategies (doubling the dose of inhaled steroids or adding a long acting beta2 agonist to the inhaled steroid at the same dose) in children not controlled by inhaled steroid alone at medium dose. The fixed combination SERETIDE 100/50 one inhalation twice daily will be compared to FLIXOTIDE 100 two inhalations twice daily.

Detailed description: A multicentre, randomised, double-blind, double dummy, parallel group study to compare the salmeterol/fluticasone propionate combination (SERETIDE™) at a dose of 50/100mcg twice daily and fluticasone propionate (FLIXOTIDE™) at a dose of 200mcg twice daily, both delivered via a dry powder inhaler (DISKUS™) for 12 weeks in asthma in children aged 4-11 years not controlled by inhaled corticosteroids alone at medium dose

Eligibility criteria: Inclusion criteria:

* A documented clinical history of asthma for a period of at least 6 months.
* A documented history (within 12 months of Visit 1) of airway reversibility of = 15% based either on Forced expiratory volume (FEV1) or PEF measured pre and post inhalation of 200 mcg salbutamol. (If no documented history of reversibility exists, patients must demonstrate a =15% reversibility at Visit 1).
* Receiving an inhaled corticosteroid at a medium dose (beclomethasone dipropionate HydroFluoroAlkane (HFA) non fine particle = 400-500 mcg/day or beclomethasone HFA fine particle = 200mcg/day, or budesonide =400 mcg/day or fluticasone = 200 mcg/day (or fluticasone 250mcg/day if subject is taking a 125mcg MDI rather than the 100mcg Diskus), for at least 3 months prior to Visit 1 and at a stable dose for at least 4 weeks prior to Visit 1.
* Able to use the Mini-Wright peak flow meter and subject or parent/guardian had to be able to record the subject's maximum PEF correctly.
* Able to perform FEV1 correctly.
* Subject's guardian/parent able to complete an eDRC on behalf of the subject. The eDRC should be completed by the guardian/parent.
* Able to use a DISKUS™ correctly.
* At least one parent(s)/guardian(s) has to give written informed consent to participate in the study.

At the end of the run-in period (Visit 2), subjects must still meet the criteria for entry into the run-in period and also have:

* not achieved the criteria for the 'Well-controlled' asthma during two or more of the 4 weeks prior to Visit 2.

Exclusion criteria:

* Female subjects who have reached menarche.
* Received any investigational study medication in the 4 weeks prior to Visit 1.
* Experienced a respiratory tract infection in the 4 weeks prior to Visit 1.
* Experienced an acute asthma exacerbation requiring emergency room treatment within 4 weeks or hospitalisation within 12 weeks of Visit 1.
* Any use of oral/parenteral or depot corticosteroid within 12 weeks of Visit 1.
* Any use of long-acting inhaled beta2-agonists or oral beta2-agonists within 4 weeks of Visit 1.
* Any use of leukotriene antagonists or theophyllines within 4 weeks of Visit 1.
* Any known clinical or laboratory evidence of a serious uncontrolled disease (including serious psychological disorders) which is, in the opinion of the investigator, likely to interfere with the study.
* Subjects with a known or suspected hypersensitivity to inhaled corticosteroids, beta2-agonists, or any components of the formulations (e.g. lactose)
* A relative of any of the site staff, including the investigator or study co-coordinator.
* Has previously been entered into this study.

Subjects will be excluded from participating in the treatment period of the study if the following occurred during the run-in period:

* Pre-bronchodilator FEV1 \<60% (assuming that measurement was correctly performed).
* Any change in asthma medication (excluding use of prophylactic study specific salbutamol for prevention of asthma symptoms due to exercise).
* Respiratory tract infection or asthma exacerbation.
* Use of oral, parenteral or depot corticosteroids.
* Emergency visit due to asthma.
* Non-compliance with the completion of the eDRC (i.e. during the 4 week period between visits, non compliance is defined as less than 5 days of completed data within any one week for four weeks - subjects must complete at least 5 days a week for the entire run-in period).

Primary outcomes:
measure: Mean Change From Baseline in Morning Peak Expiratory Flow (PEF) Over 12 Weeks in Intent-to-treat (ITT) Population
timeFrame: Baseline; Week 1 up to Week 12
measure: Mean Change From Baseline in Morning PEF Over 12 Weeks in Per Protocol (PP) Population
timeFrame: Baseline; Week 1 up to Week 12
Secondary outcomes:
measure: Number of Participants Who Achieved 'Totally Controlled' (TC) Asthma
timeFrame: Week 5 up to Week 12
measure: Number of Participants Who Achieved WC Asthma
timeFrame: Week 5 up to Week 12
Other outcomes:
Locations:
city: Brugge
country: Belgium
facility: GSK Investigational Site
city: Brussel
country: Belgium
facility: GSK Investigational Site
city: Edegem
country: Belgium
facility: GSK Investigational Site
city: Gent
country: Belgium
facility: GSK Investigational Site
city: Leuven
country: Belgium
facility: GSK Investigational Site
city: Aalborg
country: Denmark
facility: GSK Investigational Site
city: Odense
country: Denmark
facility: GSK Investigational Site
city: Essey les Nancy
country: France
facility: GSK Investigational Site
city: Grasse
country: France
facility: GSK Investigational Site
city: Laon
country: France
facility: GSK Investigational Site
city: Nimes
country: France
facility: GSK Investigational Site
city: Oyonnax
country: France
facility: GSK Investigational Site
city: Paris cedex 15
country: France
facility: GSK Investigational Site
city: Paris
country: France
facility: GSK Investigational Site
city: Rouen Cedex
country: France
facility: GSK Investigational Site
city: Rouen
country: France
facility: GSK Investigational Site
city: Saint Michel
country: France
facility: GSK Investigational Site
city: Tours Cedex 1
country: France
facility: GSK Investigational Site
city: Vaux En Velin
country: France
facility: GSK Investigational Site
city: Villejuif
country: France
facility: GSK Investigational Site
city: Napoli
country: Italy
facility: GSK Investigational Site
state: Campania
city: Foggia
country: Italy
facility: GSK Investigational Site
state: Puglia
city: Palermo
country: Italy
facility: GSK Investigational Site
state: Sicilia
city: Perugia
country: Italy
facility: GSK Investigational Site
state: Umbria
city: Daugavpils
country: Latvia
facility: GSK Investigational Site
city: Riga
country: Latvia
facility: GSK Investigational Site
city: Riga
country: Latvia
facility: GSK Investigational Site
city: Kaunas
country: Lithuania
facility: GSK Investigational Site
city: Taurage
country: Lithuania
facility: GSK Investigational Site
city: Vilnius
country: Lithuania
facility: GSK Investigational Site
city: Almere
country: Netherlands
facility: GSK Investigational Site
city: Beek En Donk
country: Netherlands
facility: GSK Investigational Site
city: Den Haag
country: Netherlands
facility: GSK Investigational Site
city: Deurne
country: Netherlands
facility: GSK Investigational Site
city: Emmen
country: Netherlands
facility: GSK Investigational Site
city: Ermelo
country: Netherlands
facility: GSK Investigational Site
city: Nieuwegein
country: Netherlands
facility: GSK Investigational Site
city: Spijkenisse
country: Netherlands
facility: GSK Investigational Site
city: Tiel
country: Netherlands
facility: GSK Investigational Site
city: Woerden
country: Netherlands
facility: GSK Investigational Site
city: Drammen
country: Norway
facility: GSK Investigational Site
city: Kongsvinger
country: Norway
facility: GSK Investigational Site
city: Oslo
country: Norway
facility: GSK Investigational Site
city: Bialystok
country: Poland
facility: GSK Investigational Site
city: Krakow
country: Poland
facility: GSK Investigational Site
city: Lodz
country: Poland
facility: GSK Investigational Site
city: Lublin
country: Poland
facility: GSK Investigational Site
city: Krasnoyarsk
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Novokuznetsk
country: Russian Federation
facility: GSK Investigational Site
city: Novosibirsk
country: Russian Federation
facility: GSK Investigational Site
city: St'Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: Syktyvkar
country: Russian Federation
facility: GSK Investigational Site
city: Tomsk
country: Russian Federation
facility: GSK Investigational Site
city: Almeria
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: San Sebastián
country: Spain
facility: GSK Investigational Site
city: Sevilla
country: Spain
facility: GSK Investigational Site
city: Sollentuna
country: Sweden
facility: GSK Investigational Site
city: Stockholm
country: Sweden
facility: GSK Investigational Site
city: Stockholm
country: Sweden
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: