Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Mylan Pharma UK Ltd.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female subjects aged ≥18 years. Females may be of either childbearing or non-childbearing potential
Physician diagnosed history of asthma for at least 12 weeks prior to screening
pre-bronchodilator FEV1 60-85% at screening and other specified visits
Post-bronchodilator reversibility \>/=12%
Non-smokers and prior smokers with no history of smoking within the past 12 months prior to screening and a total smoking history of ≤10 pack-years
Subjects able to discontinue asthma medications for the duration of the study and be maintained using albuterol as required
Body mass index between 18-40 kg/m2 inclusive
You may not be if
Presence or recent history of any other active, severe, progressive, and/or uncontrolled clinical disease, eg, poorly controlled Type 1 or 2 diabetes, seizure disorder or epilepsy, cerebrovascular accident, significant cardiac conduction abnormalities
Respiratory conditions other than asthma and allergic rhinitis, including but not limited to: severe nasal polyposis or chronic rhinosinusitis, chronic obstructive pulmonary disease, bronchiectasis, Churg-Strauss Disease, lung resection, pulmonary fibrosis (primary or secondary), pulmonary hypertension, cystic fibrosis, sarcoidosis
History of life-threatening asthma, defined as a history of asthma episode(s) requiring intubation, and/or associated with hypercapnia; respiratory arrest or hypoxic seizures, asthma related syncopal episode(s)
In patient hospitalization (not including ER visits) for an asthma exacerbation within the past year or during the run in period
An asthma exacerbation requiring change in asthma therapy or oral/IV corticosteroids in the 3 months prior to screening
History of seasonally unstable asthma where the season will coincide with the subject's participation in the study
Use of prescription or non-prescription drugs, including beta blockers, tricyclic antidepressants, oral decongestants, benzodiazepines, digitalis, phenothiazines, monoamine oxidase inhibitors, etc
Suspected hypersensitivity to the study drugs (including lactose) or severe milk protein allergy
Clinically significant abnormalities in the screening ECG
Evidence of alcohol or drug abuse or dependency within 6 months prior to screening
