Clinical trial NCT02245672 (phase 3, status: completed)
Conditions: asthma
ICD codes: J45.998, J82.83, J45.909, J45.991, J45.20, J45.30, J45.40
Drugs: mgr001 (fixed dose combination of fluticasone propionate and salmeterol xinafoate), advair (fixed dose combination of fluticasone propionate and salmeterol xinafoate), placebo
SMILES: OCC1=C(O)C=CC(=C1)C(O)CNCCCCCCOCCCCC1=CC=CC=C1, OCC1=C(O)C=CC(=C1)C(O)CNCCCCCCOCCCCC1=CC=CC=C1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Key inclusion criteria include:

          -  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

        Key exclusion criteria include:

          -  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