Last updated: 11/04/2018 11:07:27
Seretide Versus Flixotide In Asthmatic Children Not Controlled By Inhaled Corticosteroids
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
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
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:
Number of participants who achieved 'Totally Controlled' (TC) asthma
Timeframe: Week 5 up to Week 12
Number of participants who achieved WC asthma
Timeframe: Week 5 up to Week 12
Interventions:
Enrollment:
506
Primary completion date:
2006-26-10
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Asthma
Product
fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
Collaborators
Not applicable
Study date(s)
November 2005 to October 2006
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
4 - 11 years
Accepts healthy volunteers
No
- 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).
- Female subjects who have reached
- menarche.
Inclusion and exclusion 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).
Trial location(s)
Location
GSK Investigational Site
BEEK EN DONK, Netherlands, 5741 CG
Status
Terminated/Withdrawn
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2006-26-10
Actual study completion date
2006-26-10
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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