Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Chiesi Farmaceutici S.p.A.
This was a 48-week phase III, double-blind, randomized, 2-arm parallel group study in asthmatic patients (adults of both sexes) not fully controlled under ICS treatment. The study plan included: * A pre-screening visit (V0, 3-10 days before V1) to explain the aim of the study, to sign the informed consent form and to prepare patients for V1; * A screening visit (V1, week -2) to assess inclusion/exclusion criteria followed by a 2-week run-in period when the patients received Foster® 100/6μg, one inhalation twice a day plus salbutamol for reliever medication; * A randomization visit (V2, week 0) when patients were allocated to one of the two treatment arms: A) Foster® 100/6 μg one inhalation bid for maintenance plus additional inhalations as needed; B) Foster® 100/6 μg one inhalation bid for maintenance plus salbutamol as needed. * And subsequent visits taking place at clinics after 4 (V3), after 12 (V4), after 24 (V5), after 36 (V6) and after 48 weeks (V7) of treatment. The total study duration per participant was 50 weeks, including the 2-week run-in period, 48-week treatment phase. Salbutamol was used as a rescue medication.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
