MGR001 / Advair Diskus Local Equivalence Study in Asthma

Phase 3

Completed

Conditions: Asthma

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

Registration Number: NCT02245672

Lead Sponsor: Mylan Pharma UK Ltd.

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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1128

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo for Advair Diskus and MGR001 administered two times per day by inhalation throughout the study
MGR001	MGR001 (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate)	MGR001 administered two times per day by inhalation throughout the study
Advair Diskus	Advair (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate)	Advair Diskus administered two times per day by inhalation throughout the study

Primary Outcome Measures

Name	Time	Method
FEV1 Trough Value (Bioequivalence)	Day 1 and Day 29	Change from baseline in trough (pre-dose) FEV1 at Day 29 was based on 2 pre-dose FEV1 assessments performed 30 minutes apart on Day 29. Baseline was calculated by taking the mean of \[prebronchodilator FEV1 measured at a run-in visit and the mean of 2 predose FEV1 measures taken at Day 1\]
Forced Exhaled Volume in 1 Sec (FEV1) Area Under the Effect Curve on Day 1 (Bioequivalence)	0-12 hours after dosing on Day 1	The FEV1 AUEC(0-12) on Day 1 was calculated from FEV1 measurements collected 30 minutes prior to morning dose, 0 minutes prior to morning dose, and at 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours following completion of dosing on Day 1 (Visit 3). The baseline for the FEV1 AUEC(0-12) endpoint was the mean of the 2 predose FEV1 measures
Forced Exhaled Volume in 1 Sec (FEV1) Area Under the Effect Curve on Day 1 (Assay Sensitivity)	0-12 hours after dosing on Day 1	The FEV1 AUEC(0-12) on Day 1 was calculated from FEV1 measurements collected 30 minutes prior to morning dose, 0 minutes prior to morning dose, and at 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours following completion of dosing on Day 1 (Visit 3). The baseline for the FEV1 AUEC(0-12) endpoint was the mean of the 2 predose FEV1 measures. To confirm assay sensitivity, both active treatments (MGR001 and Advair Diskus) had to be significantly superior to placebo
FEV1 Trough Value (Assay Sensitivity)	Day 1 and Day 29	Change from baseline in trough (pre-dose) FEV1 at Day 29 was based on 2 pre-dose FEV1 assessments performed 30 minutes apart on Day 29. Baseline was calculated by taking the mean of \[prebronchodilator FEV1 measured at a run-in visit and the mean of 2 predose FEV1 measures taken at Day 1\]. To confirm assay sensitivity, both active treatments (MGR001 and Advair Diskus) had to be significantly superior to placebo.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (101): Mylan Investigative Site #1
🇺🇸
Birmingham, Alabama, United States
Mylan Investigative Site #2
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Little Rock, Arkansas, United States
Mylan Investigative Site #3
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Anaheim, California, United States
Mylan Investigative Site #4
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Bakersfield, California, United States
Mylan Investigative Site #5
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Burbank, California, United States
Mylan Investigative Site #6
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Costa Mesa, California, United States
Mylan Investigative Site #7
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Encinitas, California, United States
Mylan Investigative Site #8
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Fresno, California, United States
Mylan Investigative Site #9
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Fullerton, California, United States
Mylan Investigative Site #10
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Huntington Beach, California, United States
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Mylan Investigative Site #1
🇺🇸Birmingham, Alabama, United States