Asthma MedDRA version: 9.1 Level: LLT Classification code 10001705 Term: Allergic asthma
Conditions
Interventions
Trade Name: Flixotide (Fluticasone/propionate)
Product Name: Flixotide
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: FLUTICASONE PROPIONATE
CAS Number: 80474142
Concentration unit: µg mi
Sponsors
GlaxoSmithKline
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria for entry into the run-in period: 1. Male or female subjects =18 years = 50 years 2. Allergic asthma: positive skin prick test for at least one aeroallergen or RAST 3. Documented history of asthma according to GINA guidelines for a period of at least 6 months 3. Subjects who have received regular treatment with FP at a dose of 250 mcg bd or equivalent with or without a LABA for at least 4 weeks before start of the run-in period, at a constant dose 4. Subjects with history of recurrent episodes of wheezing, breathlessness, chest tigthness and/or coughing in the previous year 5. Subjects who are able to use a DISKUS inhaler 6. Subjects who are able to perform reproducible lung function tests at Visit 1 (variation FEV1 smaller than 5% between the two best measurements) Inclusion criteria for entry into the treatment period: 1. Subjects with an FEV1% of predicted bigger than 70% 2. ACT score smaller then 25 after the run-in period 3. Negative pregnancy urine test when of child bearing potential Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria for entry into the run-in period: 1. Subjects who have been hospitalised for their asthma within 4 weeks of visit 1 2. Subjects who had an acute upper respiratory tract infection within 4 weeks or a lower respiratory tract infection within 4 weeks prior to visit 1 3. Subjects who received oral, parental, or depot corticosteroids within 4 weeks prior to visit 1 4. Subjects who have a known respiratory disorder other than asthma and/or systemic/thoracic abnormalities which influence normal lung function 5. Subjects who hae received any investigational drugs within 4 weeks of visit 1 6. Subjects with a known or suspected hypersensitivity to inhaled steroids, beta2-agonists or lactose 7. Subjects who use any medication that significantly inhibits the cytochrome P450 subfamily enzyme CYP3A4, including ritonavir, ketoconazole, itraconazole and erythromycin 8. Subjects who concurrently participate in another clinical study 9. Subjects who have previously been randomised in this study 10. Subjects who have currently smoke or subjects who smoked in the last 6 months prior to the study 11. Subjects with hepatic impairment or other significant disease. Exclusion criteria for entry into the treatment period: 1. Any change in their run-in asthma medication 2. Non-compliance with the run-in medication (smaller than 70%)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate a reduction in innate immune response (assessed by priming marker A17 on blood neutrophils) in subjects with asthma treated with the salmeterol/fluticasone propionate combination product (SFC) 50/250 mcg bd compared to a treatment with fluticasone propionate (FP) 500 mcg bd alone (week 0 - week 24);Secondary Objective: To evaluate whether there is a dose dependent reduction in the innate immune response (assessed by priming marker A17 on blood neutrophils) by comparing FP 250 mcg bd and FP 500 mcb bd (week 0 - week 12);Primary end point(s): Mean change in neutrophil priming in blood as assessed by marker A17 | — |
Countries
Netherlands
Outcome results
None listed