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Randomized, Placebo-Controlled, Multidose, Study Comparing Generic Budesonide/Formoterol Fumarate Dihydrate to Symbicort® in Asthmatic Participants

NCT02495168 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1714

Last updated 2019-11-29

Study results available
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Summary

This study has a randomized multiple-dose, placebo-controlled, parallel group design consisting of a 2-week open placebo Run-in Period followed by a 6-week Treatment Period with placebo, test product (budesonide 80 microgram \[μg\]/formoterol fumarate dihydrate 4.5 μg), or reference product (Symbicort® inhalation aerosol).

Conditions

Interventions

DRUG

Generic Budesonide/Formoterol Fumarate Dihydrate

Oral inhalation, generic formulation of the brand-name product.

DRUG

Symbicort® (Budesonide/Formoterol Fumarate Dihydrate)

Oral inhalation, brand-name product.

DRUG

Placebo

Oral inhalation, no active ingredient.

Sponsors & Collaborators

  • Teva Pharmaceuticals USA

    collaborator INDUSTRY

  • Actavis Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-01-13
Primary Completion
2018-05-31
Completion
2018-05-31
FDA Drug
Yes

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 NCT02495168 on ClinicalTrials.gov