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Seretide Versus Flixotide In Asthmatic Children Not Controlled By Inhaled Corticosteroids
This study has been completed.
First Received: July 18, 2006   Last Updated: May 15, 2009   History of Changes
Sponsor: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00353873
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: Fluticasone propionate
Drug: Fluticasone propionate/salmeterol
Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study
Official Title: See Detailed Description

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • The primary endpoint is the mean morning Peak Expiratory Flow (PEF) over 12 weeks recorded in the electronic Diary Record Card (eDRC).

Secondary Outcome Measures:
  • Secondary measures of efficacy are: The proportion of subjects who achieve 'total-control asthma' and the proportion of subjects who achieve 'well-control asthma'

Estimated Enrollment: 506
Study Start Date: November 2005
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

Ages Eligible for Study:   4 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00353873

  Show 58 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GSK ( Study Director )
Study ID Numbers: SAM104926
Study First Received: July 18, 2006
Last Updated: May 15, 2009
ClinicalTrials.gov Identifier: NCT00353873     History of Changes
Health Authority: France: Afssaps - French Health Products Safety Agency

Keywords provided by GlaxoSmithKline:
asthmatics children 4-11 years
asthma-control
SERETIDE
FLIXOTIDE

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Bronchial Diseases
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic Agonists
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Therapeutic Uses
Fluticasone
Dermatologic Agents
Salmeterol
Adrenergic beta-Agonists
Immune System Diseases
Asthma
Anti-Asthmatic Agents
Anti-Allergic Agents
Pharmacologic Actions
Autonomic Agents
Lung Diseases
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on November 25, 2009