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

NCT03015259 | Completed Phase 3 Results FDA Drug

• 1 other identifier: CSP-07-000034
• Study Type: interventional
• Target: 1,762
• Locations: 1 country
• Sites: 95

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.

Conditions

Asthma

Keywords

bioequivalence

Outcome Measures

Primary Outcomes (2)

• 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.

  Day 1

• 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: \[FEV1 at end of treatment\] - \[Baseline FEV1\].

  Day 1 - Day 49

Secondary Outcomes (1)

• Number of Participants With Adverse Events

  6 Weeks

Study Arms (3)

Treatment 1

EXPERIMENTAL

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

Drug: Budesonide/Formoterol fumarate dihydrate

Treatment 2

ACTIVE COMPARATOR

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

Drug: Symbicort

Treatment 3

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Budesonide/Formoterol fumarate dihydrate DRUG

Experimental: Treatment 1

Also known as: Generic Budesonide/Formoterol fumarate dihydrate

Treatment 1

Symbicort DRUG

Active Comparator: Treatment 2

Also known as: Budesonide/Formoterol fumarate dihydrate

Treatment 2

Placebo DRUG

Placebo Comparator: Treatment 3

Treatment 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kindeva Drug Delivery: lead

Study Sites (95)

Clinical Research Center of Alabama LLC

Birmingham, Alabama, 35209, United States

Location

Elite Clinical Studies

Phoenix, Arizona, 85018, United States

Location

Clinical Research Consortuim Arizona

Tempe, Arizona, 85253, United States

Location

Little Rock Allergy and Asthma Clinical Research Center

Little Rock, Arkansas, 72205, United States

Location

Anaheim Clinical Trials LLC

Anaheim, California, 92801, United States

Location

Warren W Pleskow MD

Encinitas, California, 98104, United States

Location

Allergy and Asthma Specialists Medical Group

Huntington Beach, California, 92647, United States

Location

California Allergy and Asthma Medical Group Inc

Los Angeles, California, 90025, United States

Location

Jonathan Corren MD, Inc.

Los Angeles, California, 90025, United States

Location

Southern California Institute For Respiratory Diseases, Inc.

Los Angeles, California, 90048, United States

Location

Allergy and Asthma Associates of Southern California, A Medical Group, Inc.

Mission Viejo, California, 92691, United States

Location

Integrated Research Group Inc

Riverside, California, 92506, United States

Location

Allied Clinical Research LLC

Sacramento, California, 95842, United States

Location

Allergy and Asthma Associates of Northern California

San Jose, California, 95117, United States

Location

Allergy & Asthma Clinical Research

Walnut Creek, California, 94598, United States

Location

Allainz Research Institute Inc

Westminster, California, 92683, United States

Location

Western States Clinical Research Inc

Arvada, Colorado, 80401, United States

Location

Colorado Allergy and Asthma Centers PC

Centennial, Colorado, 80112, United States

Location

IMMUNOe Research Centers

Centennial, Colorado, 80112, United States

Location

Asthma and Allergy Associates PC

Colorado Springs, Colorado, 80907, United States

Location

Colorado Allergy and Asthma Centers PC

Denver, Colorado, 80230, United States

Location

Innovative Clinical Research Inc

Lafayette, Colorado, 80026, United States

Location

Rocky Mountain Center for Clinical Research

Wheat Ridge, Colorado, 80033, United States

Location

Saint Francis Sleep Allergy and Lung Institute

Clearwater, Florida, 33765, United States

Location

Southeastern Integrated Medical

Gainesville, Florida, 32607, United States

Location

Innovative Research of West Florida

Largo, Florida, 33756, United States

Location

San Marcus Research Clinic Inc

Miami, Florida, 33015, United States

Location

Prestige Clinical Research Center Inc

Miami, Florida, 33133, United States

Location

Clintex Research Group, Inc

Miami, Florida, 33135, United States

Location

Suncoast Research Group LLC

Miami, Florida, 33135, United States

Location

Applemed Research Inc

Miami, Florida, 33155, United States

Location

Biotech Pharmaceutical Group, LLC

Miami, Florida, 33155, United States

Location

Research Institute of South Florida Inc

Miami, Florida, 33173, United States

Location

Advanced Research Institute Inc

New Port Richey, Florida, 34653, United States

Location

Emerald Coast Research Associates

Panama City, Florida, 32405, United States

Location

Allergy and Asthma Dtc

Tallahassee, Florida, 32308, United States

Location

Asthma and Allergy Center of Chicago Sc

River Forest, Illinois, 60305, United States

Location

Analab Clinical Research Inc

Lenexa, Kansas, 66219, United States

Location

Paul Shapero's Private Practice

Bangor, Maine, 04401, United States

Location

Chesapeake Clinical Research Inc

Baltimore, Maryland, 212236, United States

Location

Bethesda Allergy Asthma and Research Center LLC

Bethesda, Maryland, 20814, United States

Location

Genesis Clinical Research and Consulting LLC

Fall River, Massachusetts, 02723, United States

Location

Infinity Medical Research LLC

North Dartmouth, Massachusetts, 02747, United States

Location

Northeast Medical Research Associates Inc

North Dartmouth, Massachusetts, 02747, United States

Location

Clinical Research Institute, Inc.

Minneapolis, Minnesota, 55402, United States

Location

Clinical Research of the Ozarks INC

Columbia, Missouri, 65203, United States

Location

Clinical Research of the Ozarks Inc

Rolla, Missouri, 65401, United States

Location

Midwest Clinical Research LLC

St Louis, Missouri, 63141, United States

Location

The Clinical Research Center LLC

St Louis, Missouri, 63141, United States

Location

Montana Medical Research

Missoula, Montana, 59808, United States

Location

Pioneer Clinical Research LLC

Bellevue, Nebraska, 68005, United States

Location

The Asthma and Allergy Center PC

Bellevue, Nebraska, 68123, United States

Location

Clinical Research Consortium Nevada

Las Vegas, Nevada, 89102, United States

Location

Allied Clinical Research LLC

Reno, Nevada, 89523, United States

Location

Ocean Allergy & Respiratory Research Center

Brick, New Jersey, 08724, United States

Location

Atlantic Research Center LLC

Ocean Township, New Jersey, 07712, United States

Location

Princeton Center For Clinical Research

Skillman, New Jersey, 08558, United States

Location

Allergy Partners of Western North Carolina

Asheville, North Carolina, 28801, United States

Location

Rapha Institute for Clinical Research

Fayetteville, North Carolina, 28314, United States

Location

North Carolina Clinical Research

Raleigh, North Carolina, 27607, United States

Location

Empirical Medical Research

Canton, Ohio, 44718, United States

Location

Bernstein Clinical Research Center Inc

Cincinnati, Ohio, 45231, United States

Location

New Horizons Clinical Research

Cincinnati, Ohio, 45242, United States

Location

Toledo Center For Clinical Research

Sylvania, Ohio, 43560, United States

Location

Toledo Institute of Clinical Research

Toledo, Ohio, 93617, United States

Location

OK Clinical Research, LLC

Edmond, Oklahoma, 73034, United States

Location

Oklahoma Institute of Allergy and Asthma Clinical Research LLC

Edmond, Oklahoma, 73131, United States

Location

Santiago Reyes, MD

Oklahoma City, Oklahoma, 73112, United States

Location

Vital Prospects Clinical Research Institute PC

Tulsa, Oklahoma, 74136, United States

Location

Allergy and Asthma Research Group

Eugene, Oregon, 97401, United States

Location

Clinical Research Institute of Southern Oregon PC

Medford, Oregon, 97504, United States

Location

Allergy Associates Research Center LLC

Portland, Oregon, 97202, United States

Location

Clinical Trial Center LLC

Jenkintown, Pennsylvania, 19046, United States

Location

Montgomery Medical Inc

Smithfield, Pennsylvania, 15478, United States

Location

Asthma & Allergy Physicians of Rhode Island Clinical Research Institute

Warwick, Rhode Island, 02886, United States

Location

ADAC Research

Greenville, South Carolina, 29607, United States

Location

National Allergy and Asthma Research, LLC

North Charleston, South Carolina, 29420, United States

Location

S. Carolina Pharmaceutical Research

Spartanburg, South Carolina, 29303, United States

Location

Spartanburg Medical Research

Spartanburg, South Carolina, 29303, United States

Location

New Phase Research & Development

Knoxville, Tennessee, 37909, United States

Location

AARA Research Center

Dallas, Texas, 75231, United States

Location

Pharmaceutical Research & Consulting Inc

Dallas, Texas, 75231, United States

Location

Western Sky Medical Research

El Paso, Texas, 79903, United States

Location

Pioneer Research Solutions

Houston, Texas, 77099, United States

Location

Metroplex Pulmonology & Sleep Center

McKinney, Texas, 75069, United States

Location

Central Texas Health Research Corporation

New Braunfels, Texas, 78130, United States

Location

Quality Assurance Research Center

San Antonio, Texas, 78207, United States

Location

Allergy and Asthma Research Center PA

San Antonio, Texas, 78229, United States

Location

Sylvana Research Associates

San Antonio, Texas, 78229, United States

Location

Allergy Asthma Research Institute

Waco, Texas, 76712, United States

Location

National Clinical Resources Inc

Provo, Utah, 84604, United States

Location

Timber Lane Allergy and Asthma Research LLC

South Burlington, Vermont, 05403, United States

Location

Clinical Research Partners LLC

Henrico, Virginia, 23233, United States

Location

Marycliff Allergy Specialists PS

Spokane, Washington, 99202, United States

Location

Allergy Asthma and Sinus Center

Greenfield, Wisconsin, 53228, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Budesonide; Budesonide, Formoterol Fumarate Drug Combination

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Formoterol Fumarate; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Drug Combinations; Pharmaceutical Preparations

Limitations and Caveats

There were no limitations to the trial protocol, no early termination or technical problems.

Results Point of Contact

• Title: Lester Harrison, PhD
• Organization: KINDEVA DRUG DELIVERY

lester.harrison@kindevadd.com

6122714814

Study Officials

• KINDEVA I DD, PhD

  Kindeva Drug Delivery

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2017
• First Posted: January 10, 2017
• Study Start: December 29, 2016
• Primary Completion: February 8, 2018
• Study Completion: February 8, 2018
• Last Updated: August 24, 2022
• Results First Posted: August 24, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (95)