MGR001 / Advair Diskus Local Equivalence Study in Asthma

Mylan

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: Advair (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate); Drug: Placebo; Drug: MGR001 (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02245672

MGR001-3001

Details and patient eligibility

About

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

Enrollment: 1,128 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,128 participants in 3 patient groups, including a placebo group

MGR001

Experimental group

Description:

MGR001 administered two times per day by inhalation throughout the study

Treatment:

Drug: MGR001 (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate)

Advair Diskus

Active Comparator group

Description:

Advair Diskus administered two times per day by inhalation throughout the study

Treatment:

Drug: Advair (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate)

Placebo

Placebo Comparator group

Description:

Placebo for Advair Diskus and MGR001 administered two times per day by inhalation throughout the study

Treatment:

Drug: Placebo