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
Completed
Completed
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:
Drug: Fluticasone propionate
Drug: Fluticasone propionate/salmeterol
Enrollment:
506
Observational study model:
Not applicable
Primary completion date:
2006-26-10
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
Completed
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.
Additional information about the trial
Participate in clinical trial
Additional information
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Click hereAccess to clinical trial data by researchers
Visit website