Randomized, Placebo-Controlled, Multidose, Study Comparing Generic Budesonide/Formoterol Fumarate Dihydrate to Symbicort® in Asthmatic Participants
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.
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
- Enrollment
- 1,714 participants
Conditions and interventions
Conditions
Interventions
- Generic Budesonide/Formoterol Fumarate Dihydrate Drug
- Symbicort® (Budesonide/Formoterol Fumarate Dihydrate) Drug
- Placebo Drug
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 12, 2017
- Primary completion
- May 30, 2018
- Completion
- May 30, 2018
- Last update posted
- Nov 28, 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 28, 2019 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02495168 live on ClinicalTrials.gov.