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

ClinicalTrials.gov ID: NCT02495168

Public ClinicalTrials.gov record NCT02495168. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Oct 17, 2026, 4:04 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Blinded, Parallel Group, Placebo-Controlled, Multiple Dose, Multicenter, Multinational Study to Compare the Therapeutic Equivalence of a Budesonide 80 μg/Formoterol Fumarate Dihydrate 4.5 μg Inhalation Aerosol (Manufactured by Catalent for Watson Laboratories Inc.) to Symbicort® (Budesonide 80 μg/Formoterol Fumarate Dihydrate 4.5 μg Inhalation Aerosol) (Manufactured by AstraZeneca) in Adolescent and Adult Patients With Asthma

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID: NCT02495168
Recruitment status: Completed
Study type: Interventional
Phase: Phase 3
Lead sponsor: Actavis Inc.; Industry
Enrollment: 1,714 participants

Conditions and interventions

Conditions

Asthma

Interventions

Drug

Eligibility (public fields only)

Age range: 12 Years to 75 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jan 13, 2017 (Actual)
Primary completion: May 31, 2018 (Actual)
Completion: May 31, 2018 (Actual)
Last update posted: Nov 29, 2019

2017 – 2018

United States locations

U.S. sites: 17
U.S. states: 12
U.S. cities: 15

Facility	City	State	ZIP	Site status
Site 100	Surprise	Arizona	—	—
Site 101	Huntington Beach	California	—	—
111	San Jose	California	—	—
114	Centennial	Colorado	—	—
104	Hialeah	Florida	—	—
103	Miami	Florida	—	—
105	Miami	Florida	—	—
107	Miami	Florida	—	—
106	Bozeman	Montana	—	—
113	Bellevue	Nebraska	—	—
112	Cincinnati	Ohio	—	—
108	Edmond	Oklahoma	—	—
115	Eugene	Oregon	—	—
116	Medford	Oregon	—	—
110	Rock Hill	South Carolina	—	—
109	Smyrna	Tennessee	—	—
102	Waco	Texas	—	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT02495168, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Nov 29, 2019 · Synced Oct 17, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02495168 live on ClinicalTrials.gov.

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