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Completed Phase 3 Interventional Results available

Randomized, Placebo-controlled, Multi-dose, Study Comparing Budesonide/Formoterol to Symbicort® in Asthmatic Patients

ClinicalTrials.gov ID: NCT03015259

Public ClinicalTrials.gov record NCT03015259. 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.

ClinicalTrials.gov public records Last synced Oct 25, 2026, 10:58 AM EDT

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

Official title

Randomized, Single Blind, Parallel Group, Placebo Controlled, Multidose Study Comparing the Therapeutic Equivalence of a 3M Budesonide/Formoterol Fumarate Inhaler and a Symbicort® Reference Inhaler in Adult Subjects With Asthma

Brief summary

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

A randomized multiple-dose, placebo-controlled, parallel group design consisting of a 2-week run-in period followed by a 6-week treatment period of the placebo, Test product (Budesonide 80 mcg / Formoterol fumarate dihydrate 4.5 mcg), or Reference product Symbicort® inhalation aerosol.

Study identification

NCT ID
NCT03015259
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Kindeva Drug Delivery
Industry
Enrollment
1,762 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
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
Dec 29, 2016 (Actual)
Primary completion
Feb 8, 2018 (Actual)
Completion
Feb 8, 2018 (Actual)
Last update posted
Aug 24, 2022

2016 – 2018

United States locations

U.S. sites
95
U.S. states
31
U.S. cities
77
Facility City State ZIP Site status
Clinical Research Center of Alabama LLC Birmingham Alabama 35209 —
Elite Clinical Studies Phoenix Arizona 85018 —
Clinical Research Consortuim Arizona Tempe Arizona 85253 —
Little Rock Allergy and Asthma Clinical Research Center Little Rock Arkansas 72205 —
Anaheim Clinical Trials LLC Anaheim California 92801 —
Warren W Pleskow MD Encinitas California 98104 —
Allergy and Asthma Specialists Medical Group Huntington Beach California 92647 —
California Allergy and Asthma Medical Group Inc Los Angeles California 90025 —
Jonathan Corren MD, Inc. Los Angeles California 90025 —
Southern California Institute For Respiratory Diseases, Inc. Los Angeles California 90048 —
Allergy and Asthma Associates of Southern California, A Medical Group, Inc. Mission Viejo California 92691 —
Integrated Research Group Inc Riverside California 92506 —
Allied Clinical Research LLC Sacramento California 95842 —
Allergy and Asthma Associates of Northern California San Jose California 95117 —
Allergy & Asthma Clinical Research Walnut Creek California 94598 —
Allainz Research Institute Inc Westminster California 92683 —
Western States Clinical Research Inc Arvada Colorado 80401 —
Colorado Allergy and Asthma Centers PC Centennial Colorado 80112 —
IMMUNOe Research Centers Centennial Colorado 80112 —
Asthma and Allergy Associates PC Colorado Springs Colorado 80907 —
Colorado Allergy and Asthma Centers PC Denver Colorado 80230 —
Innovative Clinical Research Inc Lafayette Colorado 80026 —
Rocky Mountain Center for Clinical Research Wheat Ridge Colorado 80033 —
Saint Francis Sleep Allergy and Lung Institute Clearwater Florida 33765 —
Southeastern Integrated Medical Gainesville Florida 32607 —
Innovative Research of West Florida Largo Florida 33756 —
San Marcus Research Clinic Inc Miami Florida 33015 —
Prestige Clinical Research Center Inc Miami Florida 33133 —
Clintex Research Group, Inc Miami Florida 33135 —
Suncoast Research Group LLC Miami Florida 33135 —
Applemed Research Inc Miami Florida 33155 —
Biotech Pharmaceutical Group, LLC Miami Florida 33155 —
Research Institute of South Florida Inc Miami Florida 33173 —
Advanced Research Institute Inc New Port Richey Florida 34653 —
Emerald Coast Research Associates Panama City Florida 32405 —
Allergy and Asthma Dtc Tallahassee Florida 32308 —
Asthma and Allergy Center of Chicago Sc River Forest Illinois 60305 —
Analab Clinical Research Inc Lenexa Kansas 66219 —
Paul Shapero's Private Practice Bangor Maine 04401 —
Chesapeake Clinical Research Inc Baltimore Maryland 212236 —
Bethesda Allergy Asthma and Research Center LLC Bethesda Maryland 20814 —
Genesis Clinical Research and Consulting LLC Fall River Massachusetts 02723 —
Infinity Medical Research LLC North Dartmouth Massachusetts 02747 —
Northeast Medical Research Associates Inc North Dartmouth Massachusetts 02747 —
Clinical Research Institute, Inc. Minneapolis Minnesota 55402 —
Clinical Research of the Ozarks INC Columbia Missouri 65203 —
Clinical Research of the Ozarks Inc Rolla Missouri 65401 —
Midwest Clinical Research LLC St Louis Missouri 63141 —
The Clinical Research Center LLC St Louis Missouri 63141 —
Montana Medical Research Missoula Montana 59808 —
Pioneer Clinical Research LLC Bellevue Nebraska 68005 —
The Asthma and Allergy Center PC Bellevue Nebraska 68123 —
Clinical Research Consortium Nevada Las Vegas Nevada 89102 —
Allied Clinical Research LLC Reno Nevada 89523 —
Ocean Allergy & Respiratory Research Center Brick New Jersey 08724 —
Atlantic Research Center LLC Ocean Township New Jersey 07712 —
Princeton Center For Clinical Research Skillman New Jersey 08558 —
Allergy Partners of Western North Carolina Asheville North Carolina 28801 —
Rapha Institute for Clinical Research Fayetteville North Carolina 28314 —
North Carolina Clinical Research Raleigh North Carolina 27607 —
Empirical Medical Research Canton Ohio 44718 —
Bernstein Clinical Research Center Inc Cincinnati Ohio 45231 —
New Horizons Clinical Research Cincinnati Ohio 45242 —
Toledo Center For Clinical Research Sylvania Ohio 43560 —
Toledo Institute of Clinical Research Toledo Ohio 93617 —
OK Clinical Research, LLC Edmond Oklahoma 73034 —
Oklahoma Institute of Allergy and Asthma Clinical Research LLC Edmond Oklahoma 73131 —
Santiago Reyes, MD Oklahoma City Oklahoma 73112 —
Vital Prospects Clinical Research Institute PC Tulsa Oklahoma 74136 —
Allergy and Asthma Research Group Eugene Oregon 97401 —
Clinical Research Institute of Southern Oregon PC Medford Oregon 97504 —
Allergy Associates Research Center LLC Portland Oregon 97202 —
Clinical Trial Center LLC Jenkintown Pennsylvania 19046 —
Montgomery Medical Inc Smithfield Pennsylvania 15478 —
Asthma & Allergy Physicians of Rhode Island Clinical Research Institute Warwick Rhode Island 02886 —
ADAC Research Greenville South Carolina 29607 —
National Allergy and Asthma Research, LLC North Charleston South Carolina 29420 —
S. Carolina Pharmaceutical Research Spartanburg South Carolina 29303 —
Spartanburg Medical Research Spartanburg South Carolina 29303 —
New Phase Research & Development Knoxville Tennessee 37909 —
AARA Research Center Dallas Texas 75231 —
Pharmaceutical Research & Consulting Inc Dallas Texas 75231 —
Western Sky Medical Research El Paso Texas 79903 —
Pioneer Research Solutions Houston Texas 77099 —
Metroplex Pulmonology & Sleep Center McKinney Texas 75069 —
Central Texas Health Research Corporation New Braunfels Texas 78130 —
Quality Assurance Research Center San Antonio Texas 78207 —
Allergy and Asthma Research Center PA San Antonio Texas 78229 —
Sylvana Research Associates San Antonio Texas 78229 —
Allergy Asthma Research Institute Waco Texas 76712 —
National Clinical Resources Inc Provo Utah 84604 —
Timber Lane Allergy and Asthma Research LLC South Burlington Vermont 05403 —
Clinical Research Partners LLC Henrico Virginia 23233 —
Marycliff Allergy Specialists PS Spokane Washington 99202 —
Allergy Asthma and Sinus Center Greenfield Wisconsin 53228 —

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 NCT03015259, 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 Aug 24, 2022 · Synced Oct 25, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03015259 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →