DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Seretide Versus Flixotide In Asthmatic Children Not Controlled By Inhaled Corticosteroids

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: Fluticasone propionate (Drug); Fluticasone propionate/salmeterol (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Peak Expiratory Flow (PEF)

Secondary outcome: Total and Well Control Asthma

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

Minimum age: 4 Years. Maximum age: 11 Years. Gender(s): Both.

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).

Locations and Contacts

GSK Investigational Site, Brugge 8000, Belgium

GSK Investigational Site, Brussels 1090, Belgium

GSK Investigational Site, Edegem 2650, Belgium

GSK Investigational Site, Gent 9000, Belgium

GSK Investigational Site, Leuven 3000, Belgium

GSK Investigational Site, Aalborg 9000, Denmark

GSK Investigational Site, Odense 5000 Odense C, Denmark

GSK Investigational Site, Essey les Nancy 54270, France

GSK Investigational Site, Grasse 06130, France

GSK Investigational Site, Laon 02000, France

GSK Investigational Site, Nimes 30900, France

GSK Investigational Site, Oyonnax 01100, France

GSK Investigational Site, Paris cedex 15 75730, France

GSK Investigational Site, Paris 75019, France

GSK Investigational Site, Rouen Cedex 76031, France

GSK Investigational Site, Rouen 76000, France

GSK Investigational Site, Saint Michel 16470, France

GSK Investigational Site, Tours Cedex 1 37000, France

GSK Investigational Site, Vaux en Velin 69120, France

GSK Investigational Site, Villejuif 94800, France

GSK Investigational Site, Daugavpils LV5403, Latvia

GSK Investigational Site, Riga LV 1004, Latvia

GSK Investigational Site, Riga LV 1064, Latvia

GSK Investigational Site, Kaunas LT-50425, Lithuania

GSK Investigational Site, Taurage LT-72214, Lithuania

GSK Investigational Site, Vilnius LT-10207, Lithuania

GSK Investigational Site, Almere 1315 RA, Netherlands

GSK Investigational Site, Beek En Donk 5741 CG, Netherlands

GSK Investigational Site, Den Haag 2517 EW, Netherlands

GSK Investigational Site, Deurne 5751 XJ, Netherlands

GSK Investigational Site, Emmen 7824 AA, Netherlands

GSK Investigational Site, Ermelo 3851 EX, Netherlands

GSK Investigational Site, Nieuwegein 3435 CM, Netherlands

GSK Investigational Site, Spijkenisse 3207 NB, Netherlands

GSK Investigational Site, Tiel 4002 WP, Netherlands

GSK Investigational Site, Woerden 3447 GN, Netherlands

GSK Investigational Site, Drammen N-3018, Norway

GSK Investigational Site, Kongsvinger N-2226, Norway

GSK Investigational Site, Oslo N-0855, Norway

GSK Investigational Site, Bialystok 15-274, Poland

GSK Investigational Site, Krakow 31-159, Poland

GSK Investigational Site, Lodz 93-513, Poland

GSK Investigational Site, Lublin 20-093, Poland

GSK Investigational Site, Krasnoyarsk 660022, Russian Federation

GSK Investigational Site, Moscow 115446, Russian Federation

GSK Investigational Site, Moscow 119435, Russian Federation

GSK Investigational Site, Moscow 119991, Russian Federation

GSK Investigational Site, Novokuznetsk 654063, Russian Federation

GSK Investigational Site, Novosibirsk 630099, Russian Federation

GSK Investigational Site, St'Petersburg 191144, Russian Federation

GSK Investigational Site, Syktyvkar 167011, Russian Federation

GSK Investigational Site, Tomsk 634 050, Russian Federation

GSK Investigational Site, Almeria 04009, Spain

GSK Investigational Site, Barcelona 08035, Spain

GSK Investigational Site, Madrid 28006, Spain

GSK Investigational Site, Madrid 28009, Spain

GSK Investigational Site, San Sebastián 20014, Spain

GSK Investigational Site, Sevilla 41071, Spain

GSK Investigational Site, Sollentuna SE-191 24, Sweden

GSK Investigational Site, Stockholm SE-141 86, Sweden

GSK Investigational Site, Stockholm SE-171 76, Sweden

GSK Investigational Site, Napoli, Campania 80138, Italy

GSK Investigational Site, Foggia, Puglia 71100, Italy

GSK Investigational Site, Palermo, Sicilia 90127, Italy

GSK Investigational Site, Perugia, Umbria 06122, Italy

Additional Information

Starting date: November 2005
Last updated: January 22, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017