Randomized, Placebo-controlled, Multi-dose, Study Comparing Budesonide/Formoterol to Symbicort® in Asthmatic Patients
- Conditions
- Asthma
- Interventions
- Registration Number
- NCT03015259
- Lead Sponsor
- Kindeva Drug Delivery
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1762
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment 1 Budesonide/Formoterol fumarate dihydrate 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 Treatment 3 Placebo Placebo Inhalation Aerosol, two inhalation twice daily, consisting of a 2-week run-in period followed by a 6-week treatment period Treatment 2 Symbicort 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
- Primary Outcome Measures
Name Time Method Area Under the Serial Forced Expiratory Volume in 1 Second (FEV1) Day 1 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 Day 1 - Day 49 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
Name Time Method Number of Participants With Adverse Events 6 Weeks Number of participants reporting at least one adverse event (safety population)
Trial Locations
- Locations (93)
Clinical Research Consortuim Arizona
🇺🇸Tempe, Arizona, United States
Anaheim Clinical Trials LLC
🇺🇸Anaheim, California, United States
Allergy and Asthma Specialists Medical Group
🇺🇸Huntington Beach, California, United States
Integrated Research Group Inc
🇺🇸Riverside, California, United States
Warren W Pleskow MD
🇺🇸Encinitas, California, United States
Allainz Research Institute Inc
🇺🇸Westminster, California, United States
Allergy and Asthma Associates of Southern California, A Medical Group, Inc.
🇺🇸Mission Viejo, California, United States
Allergy and Asthma Associates of Northern California
🇺🇸San Jose, California, United States
Allergy & Asthma Clinical Research
🇺🇸Walnut Creek, California, United States
Western States Clinical Research Inc
🇺🇸Arvada, Colorado, United States
Asthma and Allergy Associates PC
🇺🇸Colorado Springs, Colorado, United States
Rocky Mountain Center for Clinical Research
🇺🇸Wheat Ridge, Colorado, United States
Innovative Clinical Research Inc
🇺🇸Lafayette, Colorado, United States
Innovative Research of West Florida
🇺🇸Largo, Florida, United States
Saint Francis Sleep Allergy and Lung Institute
🇺🇸Clearwater, Florida, United States
Emerald Coast Research Associates
🇺🇸Panama City, Florida, United States
Advanced Research Institute Inc
🇺🇸New Port Richey, Florida, United States
Allergy and Asthma Dtc
🇺🇸Tallahassee, Florida, United States
Asthma and Allergy Center of Chicago Sc
🇺🇸River Forest, Illinois, United States
Genesis Clinical Research and Consulting LLC
🇺🇸Fall River, Massachusetts, United States
Chesapeake Clinical Research Inc
🇺🇸Baltimore, Maryland, United States
Infinity Medical Research LLC
🇺🇸North Dartmouth, Massachusetts, United States
Northeast Medical Research Associates Inc
🇺🇸North Dartmouth, Massachusetts, United States
Clinical Research of the Ozarks INC
🇺🇸Columbia, Missouri, United States
Clinical Research of the Ozarks Inc
🇺🇸Rolla, Missouri, United States
Midwest Clinical Research LLC
🇺🇸Saint Louis, Missouri, United States
The Clinical Research Center LLC
🇺🇸Saint Louis, Missouri, United States
Montana Medical Research
🇺🇸Missoula, Montana, United States
The Asthma and Allergy Center PC
🇺🇸Bellevue, Nebraska, United States
Pioneer Clinical Research LLC
🇺🇸Bellevue, Nebraska, United States
Ocean Allergy & Respiratory Research Center
🇺🇸Brick, New Jersey, United States
Atlantic Research Center LLC
🇺🇸Ocean Township, New Jersey, United States
Princeton Center For Clinical Research
🇺🇸Skillman, New Jersey, United States
Allergy Partners of Western North Carolina
🇺🇸Asheville, North Carolina, United States
North Carolina Clinical Research
🇺🇸Raleigh, North Carolina, United States
Rapha Institute for Clinical Research
🇺🇸Fayetteville, North Carolina, United States
Empirical Medical Research
🇺🇸Canton, Ohio, United States
Toledo Center For Clinical Research
🇺🇸Sylvania, Ohio, United States
Toledo Institute of Clinical Research
🇺🇸Toledo, Ohio, United States
OK Clinical Research, LLC
🇺🇸Edmond, Oklahoma, United States
Oklahoma Institute of Allergy and Asthma Clinical Research LLC
🇺🇸Edmond, Oklahoma, United States
Allergy and Asthma Research Group
🇺🇸Eugene, Oregon, United States
Vital Prospects Clinical Research Institute PC
🇺🇸Tulsa, Oklahoma, United States
Clinical Research Institute of Southern Oregon PC
🇺🇸Medford, Oregon, United States
Clinical Trial Center LLC
🇺🇸Jenkintown, Pennsylvania, United States
Montgomery Medical Inc
🇺🇸Smithfield, Pennsylvania, United States
Asthma & Allergy Physicians of Rhode Island Clinical Research Institute
🇺🇸Warwick, Rhode Island, United States
S. Carolina Pharmaceutical Research
🇺🇸Spartanburg, South Carolina, United States
National Allergy and Asthma Research, LLC
🇺🇸North Charleston, South Carolina, United States
Pharmaceutical Research & Consulting Inc
🇺🇸Dallas, Texas, United States
AARA Research Center
🇺🇸Dallas, Texas, United States
Western Sky Medical Research
🇺🇸El Paso, Texas, United States
Metroplex Pulmonology & Sleep Center
🇺🇸McKinney, Texas, United States
Central Texas Health Research Corporation
🇺🇸New Braunfels, Texas, United States
Allergy Asthma Research Institute
🇺🇸Waco, Texas, United States
National Clinical Resources Inc
🇺🇸Provo, Utah, United States
Clinical Research Partners LLC
🇺🇸Henrico, Virginia, United States
Marycliff Allergy Specialists PS
🇺🇸Spokane, Washington, United States
Allergy Asthma and Sinus Center
🇺🇸Greenfield, Wisconsin, United States
California Allergy and Asthma Medical Group Inc
🇺🇸Los Angeles, California, United States
Jonathan Corren MD, Inc.
🇺🇸Los Angeles, California, United States
Southern California Institute For Respiratory Diseases, Inc.
🇺🇸Los Angeles, California, United States
Pioneer Research Solutions
🇺🇸Houston, Texas, United States
San Marcus Research Clinic Inc
🇺🇸Miami, Florida, United States
Prestige Clinical Research Center Inc
🇺🇸Miami, Florida, United States
Research Institute of South Florida Inc
🇺🇸Miami, Florida, United States
Clintex Research Group, Inc
🇺🇸Miami, Florida, United States
Suncoast Research Group LLC
🇺🇸Miami, Florida, United States
Applemed Research Inc
🇺🇸Miami, Florida, United States
Biotech Pharmaceutical Group, LLC
🇺🇸Miami, Florida, United States
Clinical Research Consortium Nevada
🇺🇸Las Vegas, Nevada, United States
Quality Assurance Research Center
🇺🇸San Antonio, Texas, United States
Sylvana Research Associates
🇺🇸San Antonio, Texas, United States
Bernstein Clinical Research Center Inc
🇺🇸Cincinnati, Ohio, United States
Clinical Research Institute, Inc.
🇺🇸Minneapolis, Minnesota, United States
New Horizons Clinical Research
🇺🇸Cincinnati, Ohio, United States
Allergy and Asthma Research Center PA
🇺🇸San Antonio, Texas, United States
Analab Clinical Research Inc
🇺🇸Lenexa, Kansas, United States
Paul Shapero's Private Practice
🇺🇸Bangor, Maine, United States
ADAC Research
🇺🇸Greenville, South Carolina, United States
Little Rock Allergy and Asthma Clinical Research Center
🇺🇸Little Rock, Arkansas, United States
Allied Clinical Research LLC
🇺🇸Reno, Nevada, United States
Spartanburg Medical Research
🇺🇸Spartanburg, South Carolina, United States
Timber Lane Allergy and Asthma Research LLC
🇺🇸South Burlington, Vermont, United States
New Phase Research & Development
🇺🇸Knoxville, Tennessee, United States
Clinical Research Center of Alabama LLC
🇺🇸Birmingham, Alabama, United States
Elite Clinical Studies
🇺🇸Phoenix, Arizona, United States
Colorado Allergy and Asthma Centers PC
🇺🇸Denver, Colorado, United States
Bethesda Allergy Asthma and Research Center LLC
🇺🇸Bethesda, Maryland, United States
Santiago Reyes, MD
🇺🇸Oklahoma City, Oklahoma, United States
Allergy Associates Research Center LLC
🇺🇸Portland, Oregon, United States
IMMUNOe Research Centers
🇺🇸Centennial, Colorado, United States
Southeastern Integrated Medical
🇺🇸Gainesville, Florida, United States