Clinical trial to show equivalent efficacy and safety of fluticasone propionate (FP) delivered either through the Novolizer or through the Diskus in patients with mild to moderate persistent asthma

INTERVENTION: Product Name: Fluticasone Novolizer(R) Product Code: NA Pharmaceutical Form: Inhalation powder INN or Proposed INN: fluticasone propionate CAS Number: 80474‐14‐2 Current Sponsor code: K‐00007 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 45‐ Pharmaceutical form of the placebo: Inhalation powder Route of administration of the placebo: Inhalation use Trade Name: Flutide(R) mite 100 Diskus(R) Product Name: Flutide(R) mite 100 Diskus(R) Product Code: NA Pharmaceutical Form: Inhalation powder INN or Proposed INN: fluticasone propionate CAS Number: 80474‐14‐2 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 100‐ CONDITION: mild to moderate persistent asthma ; Classification code 10003553 PRIMARY OUTCOME: Main Objective: To show therapeutic equivalence of fluticasone propionate (FP) 100 micrograms BID delivered through the Diskus(R) and FP 45 micrograms BID delivered through the Novolizer(R) (equivalent in terms of fine particle dose to nominal FP doses of 100 micrograms administered through the Diskus(R)) in patients with mild to moderate persistent asthma. Primary end point(s): Morning pre‐dose FEV1 measurements obtained during visits (best of three readings fulfilling ATS criteria) Secondary Objective: To show superiority of FP 45 micrograms BID delivered through the Novolizer(R) compared to placebo. To compare safety and tolerability of FP 100 micrograms BID delivered through the Diskus(R) to that of FP 45 micrograms BID delivered through the Novolizer(R). INCLUSION CRITERIA: At enrolment: 1. Male or female patients aged 18 to 75 years (inclusive) 2. Previously diagnosed bronchial asthma (for at least 6 months) of mild to moderate persistent intensity, baseline FEV1 > 60 % and <= 85 % of the value predicted for the patient´s age, height and sex. 3. FEV1 reversibility of >= 15 % or 200 ml within 15 to 30 minutes following inhalation of 2 puffs of 100 micrograms salbutamol. at randomisation: 4. Best FEV1 at visit V2 within +‐ 15 % of the best FEV1 obtained at screening (V1). 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) yes F.1.3.1 Number of subjects for this age range