A Dose Range Finding Study of Formoterol Fumarate administered twice daily using the Ultrahaler™ in Patients with Asthma

INTERVENTION: Product Name: Formoterol Fumarate Dry Powder Inhaler Pharmaceutical Form: Inhalation powder INN or Proposed INN: Formoterol Fumarate CAS Number: 43229‐80‐7 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 4.5‐ Pharmaceutical form of the placebo: Inhalation powder Route of administration of the placebo: Inhalation use CONDITION: asthma bronchial ; MedDRA version: 8.0 Level: llt Classification code 10003555 PRIMARY OUTCOME: Main Objective: To investigate the efficacy of different doses of formoterol fumarate (4.5 µg bid and 9 µg bid) administered by a dry powder inhaler (Ultrahaler™) in comparison to placebo in patients with asthma Primary end point(s): Efficacy variables:; ; Primary:; · time‐averaged AUC 0‐12h of FEV1 after 1 week of treatment; ; Secondary:; · trough FEV1; · peak FEV1; · proportion of responders as determined from serial FEV1 measurements; · time to response as determined from serial FEV1 measurements; ; Safety variables:; · AEs; · physical examination; · vital signs (BP, HR); · ECG; · laboratory work‐up Secondary Objective: To study the safety and tolerability of formoterol fumarate administered by a dry powder inhaler INCLUSION CRITERIA: · written informed consent · outpatient of either sex · good health with the exception of asthma · age 18 to 65 years inclusive · history of persistent bronchial asthma (as defined by GINA 2004) for at least 6 months · pretreatment with rescue medication only during the last 4 weeks prior to B0 · FEV1 = 70 % of predicted when measured at least 6 hours after last use of short‐acting beta agonists 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