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MGR001 / Advair Diskus Local Equivalence Study in Asthma

NCT02245672 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1128

Last updated 2022-02-24

Study results available
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Summary

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

Conditions

Interventions

DRUG

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

Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered via the CRC749 inhaler device

DRUG

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

Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered via the Diskus inhaler device

DRUG

Placebo

Placebo administered via the CRC749 and Diskus devices

Sponsors & Collaborators

  • Mylan Pharma UK Ltd.

    lead INDUSTRY

Principal Investigators

  • Dik WH Ng, PhD · Mylan Pharma UK Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02245672 on ClinicalTrials.gov