MGR001 / Advair Diskus Local Equivalence Study in Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: MGR001 (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate); Advair (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate); Placebo
Intervention description: Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered via the CRC749 inhaler device; Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered via the Diskus inhaler device; Placebo administered via the CRC749 and Diskus devices
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1128.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Asthma; fluticasone; salmeterol; CRC749; Diskus; Advair; FEV1; MGR001

Summary:

      The purpose of this study is to determine whether MGR001 is equivalent to Advair Diskus when
      administered by inhalation in adult asthma patients
    

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