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
AstraZeneca
With
This is a randomised, placebo-controlled, double-blind multi center (8 countries: Europe, United States \[US\], South Africa, and Japan) study conducted on 714 subjects (102 subject per arm) with asthma symptomatic on low dose inhaled corticosteroids (ICS). The study consists of 3 periods: * Run-in period (21-28 days; visits 1 to 3) * Treatment period (12-week; Visits 4 to 7) * Follow-up (1-week; visit 8). The Run-in period consist of 3 visits: Screening visit (1), reversibility visit (2) and randomization visit (3). All subjects will sign an informed consent form (ICF) prior to participating in any study-specific procedures. Subjects found to be eligible at Visit 1 (Screening Visit) will discontinue all asthma medications and switch to low dose budesonide (200 μg twice a day \[BID\] in Europe and 180 μg BID in US) and rescue medication will be taken as needed. Subjects on long-acting beta agonist (LABA), fixed dose combination ICS/LABA treatment or a long-acting muscarinic antagonist (LAMA) will return for Visit 2 between 2 to 7 days after Visit 1 to have a sufficient wash-out time of their asthma medications. If reversibility criteria are met at Visit 2, subjects will proceed to Visit 3 (Randomization will occur within 21 to 28 days of Visit 1). At Visit 3, subjects who remain symptomatic while on low dose budesonide will be randomized in an overall ratio of 1:1:1:1:1:1:1 to one of 7 possible treatments and will receive inhalation powder via oral route: * AZD7594 DPI 55μg \[nominal strength\]/50 μg \[delivered dose\] (QD) * AZD7594 DPI 99 μg/90 μg QD * AZD7594 DPI 198 μg/180 μg QD * AZD7594 DPI 396 μg/360 μg QD * AZD7594 DPI 792 μg/720 μg QD * Placebo for AZD7594 QD * FF 100 μg QD (open-label) The follow-up will be done by telephone contact within 7 to 10 days after Visit 7 or last investigational product (IP) intake. The total duration of the study will be between 113 to 135 days for each individual subject and is planned to run approximately 12 months (it should not exceed 18 months).
Age
18–85
Sex
ALL
Healthy volunteers
Not accepted
