MedTrace Logo

A Study to Compare Fluticasone Propionate 100mcg/Salmeterol 50 mcg Inhalation Powder to Advair Discus 100/50

NCT03562923 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1204

Last updated 2018-06-20

No results posted yet for this study

Summary

To compare the efficacy and safety profiles of Fluticasone Propionate 100 mcg and Salmeterol 50 mcg Inhalation Powder (test product) and ADVAIR DISKUS (fluticasone propionate 100 mcg and salmeterol 50 mcg inhalation powder) (reference product) and to show that the efficacy of the 2 active products is superior to that of placebo in the treatment of subjects with asthma.

Conditions

Interventions

DRUG

Test Product

Fluticasone Propionate 100 mcg and Salmeterol 50 mcg Inhalation Powder

DRUG

Reference Product

ADVAIR DISKUS® 100/50 (Fluticasone Propionate 100 mcg and Salmeterol 50 mcg Inhalation Powder)

DRUG

Placebo

Placebo Product

Sponsors & Collaborators

  • Amneal Ireland Limited

    lead INDUSTRY

Principal Investigators

  • Irshad Haque · Amneal Pharmaceuticals, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-31
Primary Completion
2019-05-31
Completion
2019-06-30
FDA Drug
Yes

More Related Trials

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 NCT03562923 on ClinicalTrials.gov