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

Primary Purpose

Asthma

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Budesonide/Formoterol fumarate dihydrate
Symbicort
Placebo
Sponsored by
Kindeva Drug Delivery
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring bioequivalence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult male or female subjects of non-childbearing or of childbearing potential committed to consistent and correct use of an acceptable method of birth control
  • Diagnosed with asthma, as defined by the National Asthma Education and Prevention Program (NAEPP),at least 6 months prior to screening
  • Moderate-to-severe asthma with a pre-bronchodilator FEV1 of >45% and <85% of predicted normal, measured at least 6 hours after short-acting β agonist (SABA)and at least 24 hours after the last dose of long-acting β agonist (LABA), at the screening visit and on the day of treatment
  • >15% and >0.20 L reversibility of FEV1 within 30 minutes following 360 mcg of albuterol inhalation (pMDI)
  • Patients should be stable on their chronic asthma treatment regimen for at least 4 weeks prior to enrollment
  • Currently non-smoking; having not used tobacco products (i.e., cigarettes, cigars, pipe tobacco) within the past year, and having < 10 pack-years of historical use
  • Able to replace current regularly scheduled short-acting β agonists (SABAs) with salbutamol/albuterol inhaler for use only on an as-needed basis for the duration of the study (subjects should be able to withhold all inhaled SABAs for at least 6 hours prior to lung function assessments on study visits)
  • Willing to discontinue their asthma medications (inhaled corticosteroids and long-acting β agonists) during the run-in period and for the remainder of the study
  • Willingness to give their written informed consent to participate in the study

Exclusion Criteria:

  • Life-threatening asthma, defined as a history of asthma episodes(s) requiring intubation, and/or associated with hypercapnia, respiratory arrest or hypoxic seizures, asthma-related syncopal episodes(s), or hospitalizations within the past year or during the run-in period
  • Significant respiratory disease other than asthma (chronic obstructive pulmonary disease (COPD), interstitial lung disease, etc.)
  • Evidence or history of clinically significant disease or abnormality including congestive heart failure, uncontrolled hypertension, uncontrolled coronary artery disease, myocardial infarction, or cardiac dysrhythmia. In addition, historical or current evidence of significant hematologic, hepatic, neurologic, psychiatric, renal, or other diseases that, in the opinion of the investigator, would put the patient at risk through study participation, or would affect the study analyses if the disease exacerbated during the study
  • Patients who required systemic corticosteroids (for any reason) within the past 4 weeks
  • Hypersensitivity to any sympathomimetic drug (e.g., formoterol or albuterol) or any inhaled, intranasal, or systemic corticosteroid therapy
  • Patients currently receiving β-blockers

Sites / Locations

  • Clinical Research Center of Alabama LLC
  • Elite Clinical Studies
  • Clinical Research Consortuim Arizona
  • Little Rock Allergy and Asthma Clinical Research Center
  • Anaheim Clinical Trials LLC
  • Warren W Pleskow MD
  • Allergy and Asthma Specialists Medical Group
  • California Allergy and Asthma Medical Group Inc
  • Jonathan Corren MD, Inc.
  • Southern California Institute For Respiratory Diseases, Inc.
  • Allergy and Asthma Associates of Southern California, A Medical Group, Inc.
  • Integrated Research Group Inc
  • Allied Clinical Research LLC
  • Allergy and Asthma Associates of Northern California
  • Allergy & Asthma Clinical Research
  • Allainz Research Institute Inc
  • Western States Clinical Research Inc
  • Colorado Allergy and Asthma Centers PC
  • IMMUNOe Research Centers
  • Asthma and Allergy Associates PC
  • Colorado Allergy and Asthma Centers PC
  • Innovative Clinical Research Inc
  • Rocky Mountain Center for Clinical Research
  • Saint Francis Sleep Allergy and Lung Institute
  • Southeastern Integrated Medical
  • Innovative Research of West Florida
  • San Marcus Research Clinic Inc
  • Prestige Clinical Research Center Inc
  • Clintex Research Group, Inc
  • Suncoast Research Group LLC
  • Applemed Research Inc
  • Biotech Pharmaceutical Group, LLC
  • Research Institute of South Florida Inc
  • Advanced Research Institute Inc
  • Emerald Coast Research Associates
  • Allergy and Asthma Dtc
  • Asthma and Allergy Center of Chicago Sc
  • Analab Clinical Research Inc
  • Paul Shapero's Private Practice
  • Chesapeake Clinical Research Inc
  • Bethesda Allergy Asthma and Research Center LLC
  • Genesis Clinical Research and Consulting LLC
  • Infinity Medical Research LLC
  • Northeast Medical Research Associates Inc
  • Clinical Research Institute, Inc.
  • Clinical Research of the Ozarks INC
  • Clinical Research of the Ozarks Inc
  • Midwest Clinical Research LLC
  • The Clinical Research Center LLC
  • Montana Medical Research
  • Pioneer Clinical Research LLC
  • The Asthma and Allergy Center PC
  • Clinical Research Consortium Nevada
  • Allied Clinical Research LLC
  • Ocean Allergy & Respiratory Research Center
  • Atlantic Research Center LLC
  • Princeton Center For Clinical Research
  • Allergy Partners of Western North Carolina
  • Rapha Institute for Clinical Research
  • North Carolina Clinical Research
  • Empirical Medical Research
  • Bernstein Clinical Research Center Inc
  • New Horizons Clinical Research
  • Toledo Center For Clinical Research
  • Toledo Institute of Clinical Research
  • OK Clinical Research, LLC
  • Oklahoma Institute of Allergy and Asthma Clinical Research LLC
  • Santiago Reyes, MD
  • Vital Prospects Clinical Research Institute PC
  • Allergy and Asthma Research Group
  • Clinical Research Institute of Southern Oregon PC
  • Allergy Associates Research Center LLC
  • Clinical Trial Center LLC
  • Montgomery Medical Inc
  • Asthma & Allergy Physicians of Rhode Island Clinical Research Institute
  • ADAC Research
  • National Allergy and Asthma Research, LLC
  • S. Carolina Pharmaceutical Research
  • Spartanburg Medical Research
  • New Phase Research & Development
  • AARA Research Center
  • Pharmaceutical Research & Consulting Inc
  • Western Sky Medical Research
  • Pioneer Research Solutions
  • Metroplex Pulmonology & Sleep Center
  • Central Texas Health Research Corporation
  • Quality Assurance Research Center
  • Allergy and Asthma Research Center PA
  • Sylvana Research Associates
  • Allergy Asthma Research Institute
  • National Clinical Resources Inc
  • Timber Lane Allergy and Asthma Research LLC
  • Clinical Research Partners LLC
  • Marycliff Allergy Specialists PS
  • Allergy Asthma and Sinus Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Treatment 1

Treatment 2

Treatment 3

Arm Description

Generic Budesonide/Formoterol Fumarate Dihydrate (80mcg/4.5mcg) Inhalation Aerosol, two inhalation twice daily, consisting of a 2-week run-in period followed by a 6-week treatment period

Symbicort (Budesonide/Formoterol Fumarate Dihydrate) Inhalation Aerosol, two inhalation twice daily, consisting of a 2-week run-in period followed by a 6-week treatment period

Placebo Inhalation Aerosol, two inhalation twice daily, consisting of a 2-week run-in period followed by a 6-week treatment period

Outcomes

Primary Outcome Measures

Area Under the Serial Forced Expiratory Volume in 1 Second (FEV1)
FEV1 Area calculated over 12 hours (measurements at 0, 1, 2, 3, 4, 6, 8, 12 hours post-dose) on Day 1 of treatment. Because this was a primary endpoint, Per Protocol Population used to calculate this endpoint.
Change From Baseline in FEV1 Measured in the Morning at the End of Treatment Visit
Average predose FEV1 at End of Treatment defined as the average of all predose assessments on Day 42 (+/- 7 days). Baseline was defined as the average of 2 predose FEV1 values obtained on Day 1. The endpoint of baseline-adjusted predose FEV1 at end of treatment was calculated as follows: [FEV1 at end of treatment] - [Baseline FEV1].

Secondary Outcome Measures

Number of Participants With Adverse Events
Number of participants reporting at least one adverse event (safety population)

Full Information

First Posted
January 6, 2017
Last Updated
August 1, 2022
Sponsor
Kindeva Drug Delivery
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1. Study Identification

Unique Protocol Identification Number
NCT03015259
Brief Title
Randomized, Placebo-controlled, Multi-dose, Study Comparing Budesonide/Formoterol to Symbicort® in Asthmatic Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
December 29, 2016 (Actual)
Primary Completion Date
February 8, 2018 (Actual)
Study Completion Date
February 8, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kindeva Drug Delivery

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
This is a pivotal trial that will examine therapeutic equivalence of a new generic fixed-dose combination product containing Budesonide 80 mcg / Formoterol fumarate dihydrate 4.5 mcg and reference listed drug (RLD) Symbicort® inhalation aerosol in adult patients with chronic but stable asthma as defined in National Asthma Education and Prevention Program Expert Panel Report 3 (NAEPP 3) guidelines. To ensure adequate study sensitivity the test and reference products should both be statistically superior to placebo (p<0.05) with regard to the bioequivalent study primary endpoints. A secondary study objective is the safety and tolerability of the test compound.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
bioequivalence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1762 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment 1
Arm Type
Experimental
Arm Description
Generic Budesonide/Formoterol Fumarate Dihydrate (80mcg/4.5mcg) Inhalation Aerosol, two inhalation twice daily, consisting of a 2-week run-in period followed by a 6-week treatment period
Arm Title
Treatment 2
Arm Type
Active Comparator
Arm Description
Symbicort (Budesonide/Formoterol Fumarate Dihydrate) Inhalation Aerosol, two inhalation twice daily, consisting of a 2-week run-in period followed by a 6-week treatment period
Arm Title
Treatment 3
Arm Type
Placebo Comparator
Arm Description
Placebo Inhalation Aerosol, two inhalation twice daily, consisting of a 2-week run-in period followed by a 6-week treatment period
Intervention Type
Drug
Intervention Name(s)
Budesonide/Formoterol fumarate dihydrate
Other Intervention Name(s)
Generic Budesonide/Formoterol fumarate dihydrate
Intervention Description
Experimental: Treatment 1
Intervention Type
Drug
Intervention Name(s)
Symbicort
Other Intervention Name(s)
Budesonide/Formoterol fumarate dihydrate
Intervention Description
Active Comparator: Treatment 2
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo Comparator: Treatment 3
Primary Outcome Measure Information:
Title
Area Under the Serial Forced Expiratory Volume in 1 Second (FEV1)
Description
FEV1 Area calculated over 12 hours (measurements at 0, 1, 2, 3, 4, 6, 8, 12 hours post-dose) on Day 1 of treatment. Because this was a primary endpoint, Per Protocol Population used to calculate this endpoint.
Time Frame
Day 1
Title
Change From Baseline in FEV1 Measured in the Morning at the End of Treatment Visit
Description
Average predose FEV1 at End of Treatment defined as the average of all predose assessments on Day 42 (+/- 7 days). Baseline was defined as the average of 2 predose FEV1 values obtained on Day 1. The endpoint of baseline-adjusted predose FEV1 at end of treatment was calculated as follows: [FEV1 at end of treatment] - [Baseline FEV1].
Time Frame
Day 1 - Day 49
Secondary Outcome Measure Information:
Title
Number of Participants With Adverse Events
Description
Number of participants reporting at least one adverse event (safety population)
Time Frame
6 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult male or female subjects of non-childbearing or of childbearing potential committed to consistent and correct use of an acceptable method of birth control Diagnosed with asthma, as defined by the National Asthma Education and Prevention Program (NAEPP),at least 6 months prior to screening Moderate-to-severe asthma with a pre-bronchodilator FEV1 of >45% and <85% of predicted normal, measured at least 6 hours after short-acting β agonist (SABA)and at least 24 hours after the last dose of long-acting β agonist (LABA), at the screening visit and on the day of treatment >15% and >0.20 L reversibility of FEV1 within 30 minutes following 360 mcg of albuterol inhalation (pMDI) Patients should be stable on their chronic asthma treatment regimen for at least 4 weeks prior to enrollment Currently non-smoking; having not used tobacco products (i.e., cigarettes, cigars, pipe tobacco) within the past year, and having < 10 pack-years of historical use Able to replace current regularly scheduled short-acting β agonists (SABAs) with salbutamol/albuterol inhaler for use only on an as-needed basis for the duration of the study (subjects should be able to withhold all inhaled SABAs for at least 6 hours prior to lung function assessments on study visits) Willing to discontinue their asthma medications (inhaled corticosteroids and long-acting β agonists) during the run-in period and for the remainder of the study Willingness to give their written informed consent to participate in the study Exclusion Criteria: Life-threatening asthma, defined as a history of asthma episodes(s) requiring intubation, and/or associated with hypercapnia, respiratory arrest or hypoxic seizures, asthma-related syncopal episodes(s), or hospitalizations within the past year or during the run-in period Significant respiratory disease other than asthma (chronic obstructive pulmonary disease (COPD), interstitial lung disease, etc.) Evidence or history of clinically significant disease or abnormality including congestive heart failure, uncontrolled hypertension, uncontrolled coronary artery disease, myocardial infarction, or cardiac dysrhythmia. In addition, historical or current evidence of significant hematologic, hepatic, neurologic, psychiatric, renal, or other diseases that, in the opinion of the investigator, would put the patient at risk through study participation, or would affect the study analyses if the disease exacerbated during the study Patients who required systemic corticosteroids (for any reason) within the past 4 weeks Hypersensitivity to any sympathomimetic drug (e.g., formoterol or albuterol) or any inhaled, intranasal, or systemic corticosteroid therapy Patients currently receiving β-blockers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
KINDEVA I DD, PhD
Organizational Affiliation
Kindeva Drug Delivery
Official's Role
Study Chair
Facility Information:
Facility Name
Clinical Research Center of Alabama LLC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Elite Clinical Studies
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Clinical Research Consortuim Arizona
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85253
Country
United States
Facility Name
Little Rock Allergy and Asthma Clinical Research Center
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Anaheim Clinical Trials LLC
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Warren W Pleskow MD
City
Encinitas
State/Province
California
ZIP/Postal Code
98104
Country
United States
Facility Name
Allergy and Asthma Specialists Medical Group
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
California Allergy and Asthma Medical Group Inc
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Jonathan Corren MD, Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Southern California Institute For Respiratory Diseases, Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Allergy and Asthma Associates of Southern California, A Medical Group, Inc.
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Facility Name
Integrated Research Group Inc
City
Riverside
State/Province
California
ZIP/Postal Code
92506
Country
United States
Facility Name
Allied Clinical Research LLC
City
Sacramento
State/Province
California
ZIP/Postal Code
95842
Country
United States
Facility Name
Allergy and Asthma Associates of Northern California
City
San Jose
State/Province
California
ZIP/Postal Code
95117
Country
United States
Facility Name
Allergy & Asthma Clinical Research
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Allainz Research Institute Inc
City
Westminster
State/Province
California
ZIP/Postal Code
92683
Country
United States
Facility Name
Western States Clinical Research Inc
City
Arvada
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States
Facility Name
Colorado Allergy and Asthma Centers PC
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
IMMUNOe Research Centers
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
Asthma and Allergy Associates PC
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Colorado Allergy and Asthma Centers PC
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
Innovative Clinical Research Inc
City
Lafayette
State/Province
Colorado
ZIP/Postal Code
80026
Country
United States
Facility Name
Rocky Mountain Center for Clinical Research
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
Saint Francis Sleep Allergy and Lung Institute
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Southeastern Integrated Medical
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Innovative Research of West Florida
City
Largo
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
San Marcus Research Clinic Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33015
Country
United States
Facility Name
Prestige Clinical Research Center Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
Facility Name
Clintex Research Group, Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
Suncoast Research Group LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
Applemed Research Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Biotech Pharmaceutical Group, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Research Institute of South Florida Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Advanced Research Institute Inc
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34653
Country
United States
Facility Name
Emerald Coast Research Associates
City
Panama City
State/Province
Florida
ZIP/Postal Code
32405
Country
United States
Facility Name
Allergy and Asthma Dtc
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Asthma and Allergy Center of Chicago Sc
City
River Forest
State/Province
Illinois
ZIP/Postal Code
60305
Country
United States
Facility Name
Analab Clinical Research Inc
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States
Facility Name
Paul Shapero's Private Practice
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
Chesapeake Clinical Research Inc
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
212236
Country
United States
Facility Name
Bethesda Allergy Asthma and Research Center LLC
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20814
Country
United States
Facility Name
Genesis Clinical Research and Consulting LLC
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02723
Country
United States
Facility Name
Infinity Medical Research LLC
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Facility Name
Northeast Medical Research Associates Inc
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Facility Name
Clinical Research Institute, Inc.
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55402
Country
United States
Facility Name
Clinical Research of the Ozarks INC
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65203
Country
United States
Facility Name
Clinical Research of the Ozarks Inc
City
Rolla
State/Province
Missouri
ZIP/Postal Code
65401
Country
United States
Facility Name
Midwest Clinical Research LLC
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
The Clinical Research Center LLC
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Montana Medical Research
City
Missoula
State/Province
Montana
ZIP/Postal Code
59808
Country
United States
Facility Name
Pioneer Clinical Research LLC
City
Bellevue
State/Province
Nebraska
ZIP/Postal Code
68005
Country
United States
Facility Name
The Asthma and Allergy Center PC
City
Bellevue
State/Province
Nebraska
ZIP/Postal Code
68123
Country
United States
Facility Name
Clinical Research Consortium Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Allied Clinical Research LLC
City
Reno
State/Province
Nevada
ZIP/Postal Code
89523
Country
United States
Facility Name
Ocean Allergy & Respiratory Research Center
City
Brick
State/Province
New Jersey
ZIP/Postal Code
08724
Country
United States
Facility Name
Atlantic Research Center LLC
City
Ocean Township
State/Province
New Jersey
ZIP/Postal Code
07712
Country
United States
Facility Name
Princeton Center For Clinical Research
City
Skillman
State/Province
New Jersey
ZIP/Postal Code
08558
Country
United States
Facility Name
Allergy Partners of Western North Carolina
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Rapha Institute for Clinical Research
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28314
Country
United States
Facility Name
North Carolina Clinical Research
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Empirical Medical Research
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Bernstein Clinical Research Center Inc
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45231
Country
United States
Facility Name
New Horizons Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Toledo Center For Clinical Research
City
Sylvania
State/Province
Ohio
ZIP/Postal Code
43560
Country
United States
Facility Name
Toledo Institute of Clinical Research
City
Toledo
State/Province
Ohio
ZIP/Postal Code
93617
Country
United States
Facility Name
OK Clinical Research, LLC
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73034
Country
United States
Facility Name
Oklahoma Institute of Allergy and Asthma Clinical Research LLC
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73131
Country
United States
Facility Name
Santiago Reyes, MD
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Vital Prospects Clinical Research Institute PC
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Allergy and Asthma Research Group
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Clinical Research Institute of Southern Oregon PC
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Allergy Associates Research Center LLC
City
Portland
State/Province
Oregon
ZIP/Postal Code
97202
Country
United States
Facility Name
Clinical Trial Center LLC
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Facility Name
Montgomery Medical Inc
City
Smithfield
State/Province
Pennsylvania
ZIP/Postal Code
15478
Country
United States
Facility Name
Asthma & Allergy Physicians of Rhode Island Clinical Research Institute
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
ADAC Research
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
National Allergy and Asthma Research, LLC
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29420
Country
United States
Facility Name
S. Carolina Pharmaceutical Research
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Spartanburg Medical Research
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
New Phase Research & Development
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
AARA Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Pharmaceutical Research & Consulting Inc
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Western Sky Medical Research
City
El Paso
State/Province
Texas
ZIP/Postal Code
79903
Country
United States
Facility Name
Pioneer Research Solutions
City
Houston
State/Province
Texas
ZIP/Postal Code
77099
Country
United States
Facility Name
Metroplex Pulmonology & Sleep Center
City
McKinney
State/Province
Texas
ZIP/Postal Code
75069
Country
United States
Facility Name
Central Texas Health Research Corporation
City
New Braunfels
State/Province
Texas
ZIP/Postal Code
78130
Country
United States
Facility Name
Quality Assurance Research Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78207
Country
United States
Facility Name
Allergy and Asthma Research Center PA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Sylvana Research Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Allergy Asthma Research Institute
City
Waco
State/Province
Texas
ZIP/Postal Code
76712
Country
United States
Facility Name
National Clinical Resources Inc
City
Provo
State/Province
Utah
ZIP/Postal Code
84604
Country
United States
Facility Name
Timber Lane Allergy and Asthma Research LLC
City
South Burlington
State/Province
Vermont
ZIP/Postal Code
05403
Country
United States
Facility Name
Clinical Research Partners LLC
City
Henrico
State/Province
Virginia
ZIP/Postal Code
23233
Country
United States
Facility Name
Marycliff Allergy Specialists PS
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Allergy Asthma and Sinus Center
City
Greenfield
State/Province
Wisconsin
ZIP/Postal Code
53228
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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