Seretide Versus Flixotide In Asthmatic Children Not Controlled By Inhaled Corticosteroids

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00353873
First received: July 18, 2006
Last updated: March 13, 2014
Last verified: March 2014
  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 4

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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Peak Expiratory Flow (PEF) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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:
  • Total and Well Control Asthma [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Secondary measures of efficacy are: The proportion of subjects who achieve 'total-control asthma' and the proportion of subjects who achieve 'well-control asthma'


Enrollment: 506
Study Start Date: November 2005
Study Completion Date: October 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Fluticasone propionate (FLIXOTIDE™)
Fluticasone propionate (FLIXOTIDE™) at a dose of 200μg twice daily
Drug: Fluticasone propionate
200μg twice daily
Experimental: Fluticasone propionate/salmeterol (SERETIDE™)
Salmeterol/fluticasone propionate combination (SERETIDE™) at a dose of 50/100μg twice daily
Drug: Fluticasone propionate/salmeterol
50/100μg twice daily
Other Names:
  • Fluticasone propionate
  • Fluticasone propionate/salmeterol

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 65 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00353873     History of Changes
Other Study ID Numbers: SAM104926
Study First Received: July 18, 2006
Last Updated: March 13, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Salmeterol
Fluticasone
Fluticasone, salmeterol drug combination
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents
Glucocorticoids

ClinicalTrials.gov processed this record on April 16, 2014