FFA115283: a RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED (WHIT RESCUE MEDICATION), MULTI-CENTRE STUDY TO EVALUATE THE EFFICACY AND SAFETY OF INHALED FLUTICASONE FUROATE IN THE TREATMENT OF PERSISTENT ASTHMA IN ADULTS AND ADOLESCENTS NOT CURRENTLY RECEIVING INHALED CORTICOSTEROIDS

INTERVENTION: SUBJECTS MEETING ALL THE INCLUSION CRITERIA AND NONE OF THE EXCLUSION CRITERIA DURING VISIT 1 (SCREENING VISIT) WILL ENTER A TWO WEEK RUN‐IN PERIOD. SUBJECTS FAILING SCREENING WILL NOT BE ELIGIBLE FOR RE‐SCREENING. DURING THE RUN‐IN AND DOUBLE‐BLIND TREATMENT PERIODS SUBJECTS WILL MAINTAIN A DAILY ELECTRONIC DIARY (eDIARY) TO RECORD MORNING AND EVENING PEAK EXPIRATORY FLOW (PEF), ASTHMA SYMPTOMS SCORE AND THE RESCUE ALBUTEROL/SALBUTAMOL USE. AT VISIT 2 (END OF RUN‐IN/RANDOMIZATION VISIT) SUBJECTS MEETING THE ELIGIBILITY CRITERIA WILL BE RANDOMIZED TO ONE OF THE FOLLOWING TREATMENT GROUPS: • FLUTICASONE FUROATE 50 mcg VIA NOVEL DRY POWDER INHALER ONCE DAILY IN THE EVENING. • PLACEBO VIA NOVEL DRY POWDER INHALER ONCE DAILY IN THE EVENING. IN ADDITION ALL SUBJECTS WILL BE SUPPLIED WITH ALBUTEROL/ SALBUTAMOL INHALATION AEROSOL TO USE AS REQUIRED TO TREAT SYMPTOMS. SUBJECTS TAKING A NON‐CORTICOSTEROID CONTROLLER WILL RECEIVE THE LAST DOSE IN THE EVENING PRIOR TO VISIT 1 AND NOT TAKE UNTIL AFTER BLINDED TREATMENT IS COMPLETED (VISIT 6/EARLY WITHDRAWAL [EW]). SUBJECTS WILL THEN ATTEND 4 ON‐TREATMENT VISITS 3, 4, 5 AND 6 (WEEK 2, 4, 8 AND 12, RESPECTIVELY). CONDITION: PRIMARY OUTCOME: Change from baseline in evening clinic visit (pre‐bronchodilator and pre‐dose) FEV1 at the end of 12‐week treatment period.; NAME OF THE RESULT: Change from baseline in evening clinic visit (pre‐bronchodilator and pre‐dose) FEV1 at the end of 12‐week treatment period.; USED MEASURING METHOD :Analysis of co‐variance (ANCOVA) model and a mixed model repeated measures (MMRM) model to confirm the robustness of the primary analysis.; PERIOD OF TIME WHERE THE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Up to 12 weeks. SECONDARY OUTCOME: • Change from baseline in the percentage of rescue‐free 24 hour periods. ; • Percentage of 24‐hour periods with no asthma symptoms over the 12‐week treatment period. ; NAME OF THE RESULT: • Change from baseline in the percentage of rescue‐free 24 hour periods. ; • Percentage of 24‐hour periods with no asthma symptoms over the 12‐week treatment period. ; USED MEASURING METHOD :ANCOVA model ; PERIOD OF TIME WHERE THE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE SECONDARY RESULT: Up to 12 weeks. INCLUSION CRITERIA: 1. INFORMED CONSENT: SUBJECTS MUST GIVE THEIR SIGNED AND DATED WRITTEN INFORMED CONSENT TO PARTICIPATE. 2. TYPE OF SUBJECT: OUTPATIENT 12 YEARS OF AGE OR OLDER AT THE VISIT 1 (O ≥ 18 YEARS OF AGE IF LOCAL REGULATIONS OR THE REGULATORY STATUS OF STUDY MEDICATION PERMIT ENROLLMENT OF ADULTS ONLY) WITH A DIAGNOSIS OF ASTHMA AS DEFINED BY THE NATIONAL INSTITUTES OF HEALTH [NIH, 2007] AT LEAST 12 WEEKS PRIOR TO VISIT 1. NOTE: TARGET TO RANDOMISE APPROXIMATELY 12% OF SUBJECTS AGED 12‐17 YEARS. 3. GENDER: MALE OR ELEGIBLE FEMALE, DEFINED AS NON‐CHILDBEARING POTENTIAL OR CHILDBEARING POTENTIAL USING AN ACCEPTABLE METHOD OF BIRTH CONTROL CONSISTENTLY AND CORRECTLY, DEFINED AS BY THE FOLLOWING: • MALE PARTNER WHO IS STERILE PRIOR TO THE FEMALE SUBJECT´S ENTRY INTO THE STUDY AND IS THE SOLE SEXUAL PARTNER FOR THAT FEMALE SUBJECT. • IMPLANTS OF LEVONORGESTREL. • INJECTABLE PROGESTOGEN. • ORAL CONTRACEPTIVE (EITHER COMBINED ESTROGEN/PROGESTIN OR