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BE Study Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg Inhalation Product in Asthma Patient

NCT05322707 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1485

Last updated 2023-08-30

No results posted yet for this study

Summary

The purpose of the study is to demonstrate the Pharmacodynamic bioequivalence of the test product to the reference product in adult patient with Asthma

Conditions

Interventions

DRUG

Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg

Inhalation aerosol, 2 actuations orally inhaled twice daily

DRUG

Symbicort, 80 Mcg-4.5 Mcg/Inh Inhalation Aerosol

Inhalation aerosol, 2 actuations orally inhaled twice daily

DRUG

Placebo

Inhalation aerosol, 2 actuations orally inhaled twice daily

Sponsors & Collaborators

  • Cipla Ltd.

    lead INDUSTRY

Principal Investigators

  • Orlando Rivero, MD · Global Research Solution

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-04-15
Primary Completion
2023-08-15
Completion
2023-08-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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 NCT05322707 on ClinicalTrials.gov