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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, 2017
Last verified: November 2016
  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
Intervention Model: Parallel Assignment
Masking: Participant, 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:
  • Mean Change From Baseline in Morning Peak Expiratory Flow (PEF) Over 12 Weeks in Intent-to-treat (ITT) Population [ Time Frame: Baseline; Week 1 up to Week 12 ]
    PEF is the maximum flow generated during expiration, as measured with a peak flow meter and recorded in electronic diary record card (eDRC), performed with maximal force and started after a full inspiration. The mean morning PEF measurement was constructed by calculating a simple mean for each participant over the interval Weeks 1 to 12. All PEF measurements were converted to the Wright/McKerow peak flow meter scale for the purposes of analyses. The change from Baseline is then calculated by subtracting the Baseline PEF values from the individual on-treatment values. Baseline was calculated as the mean of the values recorded on the seven days preceding randomization. The analysis was done using analysis of covariance (ANCOVA) adjusted for baseline PEF, country amalgamation, age, sex and treatment.

  • Mean Change From Baseline in Morning PEF Over 12 Weeks in Per Protocol (PP) Population [ Time Frame: Baseline; Week 1 up to Week 12 ]
    PEF is the maximum flow generated during expiration, as measured with a peak flow meter and recorded in eDRC, performed with maximal force and started after a full inspiration. The mean morning PEF measurement was constructed by calculating a simple mean for each participant over the interval Weeks 1 to 12. All PEF measurements were converted to the Wright/McKerow peak flow meter scale for the purposes of analyses. The change from Baseline is then calculated by subtracting the Baseline PEF values from the individual on-treatment values. Baseline was calculated as the mean of the values recorded on the seven days preceding randomization. The analysis was done using ANCOVA adjusted for baseline PEF, country amalgamation, age, sex and treatment.


Secondary Outcome Measures:
  • Number of Participants Who Achieved 'Totally Controlled' (TC) Asthma [ Time Frame: Week 5 up to Week 12 ]
    TC asthma is defined as no daily symptoms, no night-time wakening due to asthma, no exacerbations, no rescue salbutamol/albuterol use, no emergency visits, >=80% predicted morning PEF, and no treatment related adverse events enforcing a change in asthma therapy over 7 consecutive days. Number of participants/group who achieved the status of at least TC during the last 8 weeks (wks) of treatment was analyzed using logistic regression, including covariates for sex, age, treatment group, country amalgamation and baseline pre-bronchodilator Forced Expiratory Volume in one second (FEV1). Asthma control was assessed each week for the last 8 wks of treatment period. Each week was classified as 'TC', 'Well Controlled' (WC), 'Not Controlled' or 'Unevaluable'. A participant was considered to have TC asthma if they achieved 4/4, 5/5, 6/6, 6/7, 7/8 or 8/8 wks that were TC. 'Unevaluable' classification included participants with less than 4 wks of data during the assessment period.

  • Number of Participants Who Achieved WC Asthma [ Time Frame: Week 5 up to Week 12 ]
    WC asthma is defined as two or more of symptom score >1 only allowed on <=2 days/week, rescue salbutamol/albuterol use on <=2 days/week and up to a maximum of 4 times per week, >=80% predicted morning PEF daily assessed for 7 consecutive days and all the following criteria: no night-time awakening due to asthma, no exacerbations, no emergency visits, no treatment related adverse events enforcing a change in any asthma therapy. Number of participants/group who achieved the status of at least WC during the last 8 wks of treatment was analyzed using logistic regression, including covariates for sex, age, treatment group, country amalgamation and baseline prebronchodilator FEV1. Each week was classified as 'WC', 'Not Controlled' or 'Unevaluable'. A participant was considered to have WC asthma if they achieved 4/4, 5/5, 6/6, 6/7, 7/8 or 8/8 wks that were WC. 'Unevaluable' classification included participants with less than 4 wks of data during the assessment period.


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 Name: Fluticasone propionate

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   (Child)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00353873     History of Changes
Other Study ID Numbers: SAM104926
Study First Received: July 18, 2006
Results First Received: March 13, 2017
Last Updated: March 13, 2017

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
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
Salmeterol Xinafoate
Fluticasone
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Sympathomimetics
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on June 28, 2017