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

Conditions: Asthma

Registration Number: EUCTR2005-002949-40-LV

Lead Sponsor: GlaxoSmithKline Centre of Excellence

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 340

Inclusion Criteria

1. Male or female children aged 4-11 years

2. A documented clinical history of asthma for a period of at least 6 months

3. Documented airway reversibility of = 15% based either on FEV1 or PEF measured pre and post inhalation of 200 mcg salbutamol must be demonstrated at Visit 1

4. Receiving an inhaled corticosteroid at a medium dose (beclomethasone dipropionate 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) for at least 3 months prior to Visit 1 and at a stable dose for at least 4 weeks prior to Visit 1

5. 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

6. Able to perform FEV1 correctly

7. Subject’s guardian/parent able to complete an eDRC on behalf of the subject. The eDRC should be completed by the guardian/parent.

8. Able to use a DISKUS™ correctly

9. At least one parent(s)/guardian(s) has to give written informed consent to participate in the study

10. 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

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion criteria for entry into the run-in period: A subject will not be eligible for inclusion in this study if any of the following criteria apply:

- 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

Exclusion criteria for entry into the treatment period: 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).