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AsthmaPhase 3NCT03015259

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

A Phase 3 study testing Budesonide/Formoterol fumarate dihydrate and Symbicort in people with Asthma, run by Kindeva Drug Delivery at 95 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Asthma
What is being tested?
Budesonide/Formoterol fumarate dihydrate and Symbicort
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,762 participants
Where
95 sitesUnited States
Study dates
29 Dec 2016to 8 Feb 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

95 sites in 1 country.

95 sites in 1 country

United States95 sites

  • Anaheim Clinical Trials LLC

    Anaheim, California, 92801

  • Western States Clinical Research Inc

    Arvada, Colorado, 80401

  • Allergy Partners of Western North Carolina

    Asheville, North Carolina, 28801

  • Chesapeake Clinical Research Inc

    Baltimore, Maryland, 212236

  • Paul Shapero's Private Practice

    Bangor, Maine, 04401

  • Pioneer Clinical Research LLC

    Bellevue, Nebraska, 68005

  • The Asthma and Allergy Center PC

    Bellevue, Nebraska, 68123

  • Bethesda Allergy Asthma and Research Center LLC

    Bethesda, Maryland, 20814

  • Clinical Research Center of Alabama LLC

    Birmingham, Alabama, 35209

  • Ocean Allergy & Respiratory Research Center

    Brick, New Jersey, 08724

  • Empirical Medical Research

    Canton, Ohio, 44718

  • Colorado Allergy and Asthma Centers PC

    Centennial, Colorado, 80112

  • IMMUNOe Research Centers

    Centennial, Colorado, 80112

  • Bernstein Clinical Research Center Inc

    Cincinnati, Ohio, 45231

  • New Horizons Clinical Research

    Cincinnati, Ohio, 45242

  • Saint Francis Sleep Allergy and Lung Institute

    Clearwater, Florida, 33765

  • Asthma and Allergy Associates PC

    Colorado Springs, Colorado, 80907

  • Clinical Research of the Ozarks INC

    Columbia, Missouri, 65203

  • AARA Research Center

    Dallas, Texas, 75231

  • Pharmaceutical Research & Consulting Inc

    Dallas, Texas, 75231

  • Colorado Allergy and Asthma Centers PC

    Denver, Colorado, 80230

  • OK Clinical Research, LLC

    Edmond, Oklahoma, 73034

  • Oklahoma Institute of Allergy and Asthma Clinical Research LLC

    Edmond, Oklahoma, 73131

  • Western Sky Medical Research

    El Paso, Texas, 79903

  • Warren W Pleskow MD

    Encinitas, California, 98104

  • Allergy and Asthma Research Group

    Eugene, Oregon, 97401

  • Genesis Clinical Research and Consulting LLC

    Fall River, Massachusetts, 02723

  • Rapha Institute for Clinical Research

    Fayetteville, North Carolina, 28314

  • Southeastern Integrated Medical

    Gainesville, Florida, 32607

  • Allergy Asthma and Sinus Center

    Greenfield, Wisconsin, 53228

  • ADAC Research

    Greenville, South Carolina, 29607

  • Clinical Research Partners LLC

    Henrico, Virginia, 23233

  • Pioneer Research Solutions

    Houston, Texas, 77099

  • Allergy and Asthma Specialists Medical Group

    Huntington Beach, California, 92647

  • Clinical Trial Center LLC

    Jenkintown, Pennsylvania, 19046

  • New Phase Research & Development

    Knoxville, Tennessee, 37909

  • Innovative Clinical Research Inc

    Lafayette, Colorado, 80026

  • Innovative Research of West Florida

    Largo, Florida, 33756

  • Clinical Research Consortium Nevada

    Las Vegas, Nevada, 89102

  • Analab Clinical Research Inc

    Lenexa, Kansas, 66219

  • Little Rock Allergy and Asthma Clinical Research Center

    Little Rock, Arkansas, 72205

  • 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

  • Metroplex Pulmonology & Sleep Center

    McKinney, Texas, 75069

  • Clinical Research Institute of Southern Oregon PC

    Medford, Oregon, 97504

  • 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

  • Clinical Research Institute, Inc.

    Minneapolis, Minnesota, 55402

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

    Mission Viejo, California, 92691

  • Montana Medical Research

    Missoula, Montana, 59808

  • Central Texas Health Research Corporation

    New Braunfels, Texas, 78130

  • Advanced Research Institute Inc

    New Port Richey, Florida, 34653

  • National Allergy and Asthma Research, LLC

    North Charleston, South Carolina, 29420

  • Infinity Medical Research LLC

    North Dartmouth, Massachusetts, 02747

  • Northeast Medical Research Associates Inc

    North Dartmouth, Massachusetts, 02747

  • Atlantic Research Center LLC

    Ocean Township, New Jersey, 07712

  • Santiago Reyes, MD

    Oklahoma City, Oklahoma, 73112

  • Emerald Coast Research Associates

    Panama City, Florida, 32405

  • Elite Clinical Studies

    Phoenix, Arizona, 85018

  • Allergy Associates Research Center LLC

    Portland, Oregon, 97202

  • National Clinical Resources Inc

    Provo, Utah, 84604

  • North Carolina Clinical Research

    Raleigh, North Carolina, 27607

  • Allied Clinical Research LLC

    Reno, Nevada, 89523

  • Asthma and Allergy Center of Chicago Sc

    River Forest, Illinois, 60305

  • Integrated Research Group Inc

    Riverside, California, 92506

  • Clinical Research of the Ozarks Inc

    Rolla, Missouri, 65401

  • Allied Clinical Research LLC

    Sacramento, California, 95842

  • 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 and Asthma Associates of Northern California

    San Jose, California, 95117

  • Princeton Center For Clinical Research

    Skillman, New Jersey, 08558

  • Montgomery Medical Inc

    Smithfield, Pennsylvania, 15478

  • Timber Lane Allergy and Asthma Research LLC

    South Burlington, Vermont, 05403

  • S. Carolina Pharmaceutical Research

    Spartanburg, South Carolina, 29303

  • Spartanburg Medical Research

    Spartanburg, South Carolina, 29303

  • Marycliff Allergy Specialists PS

    Spokane, Washington, 99202

  • Midwest Clinical Research LLC

    St Louis, Missouri, 63141

  • The Clinical Research Center LLC

    St Louis, Missouri, 63141

  • Toledo Center For Clinical Research

    Sylvania, Ohio, 43560

  • Allergy and Asthma Dtc

    Tallahassee, Florida, 32308

  • Clinical Research Consortuim Arizona

    Tempe, Arizona, 85253

  • Toledo Institute of Clinical Research

    Toledo, Ohio, 93617

  • Vital Prospects Clinical Research Institute PC

    Tulsa, Oklahoma, 74136

  • Allergy Asthma Research Institute

    Waco, Texas, 76712

  • Allergy & Asthma Clinical Research

    Walnut Creek, California, 94598

  • Asthma & Allergy Physicians of Rhode Island Clinical Research Institute

    Warwick, Rhode Island, 02886

  • Allainz Research Institute Inc

    Westminster, California, 92683

  • Rocky Mountain Center for Clinical Research

    Wheat Ridge, Colorado, 80033

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Asthma
Being tested
Budesonide/Formoterol fumarate dihydrate, Symbicort, Placebo
Keywords
bioequivalence
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Budesonide/Formoterol fumarate dihydrateDrug

    Also called Generic Budesonide/Formoterol fumarate dihydrate

    Experimental: Treatment 1

  • SymbicortDrug

    Also called Budesonide/Formoterol fumarate dihydrate

    Active Comparator: Treatment 2

  • PlaceboDrug

    Placebo Comparator: Treatment 3

Study groups in NCT03015259
Study groupRoleWhat they receive
Treatment 1ExperimentalGeneric 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
Receives: Drug: Budesonide/Formoterol fumarate dihydrate
Treatment 2Active comparatorSymbicort (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
Receives: Drug: Symbicort
Treatment 3Placebo comparatorPlacebo Inhalation Aerosol, two inhalation twice daily, consisting of a 2-week run-in period followed by a 6-week treatment period
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Day 1

  2. 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].

    Measured: Day 1 - Day 49

Secondary outcomes (1)

  1. Number of Participants With Adverse Events

    Number of participants reporting at least one adverse event (safety population)

    Measured: 6 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2017 (estimated)
  2. Study start29 Dec 2016
  3. Primary completion8 Feb 2018
  4. Study completion8 Feb 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
1,762 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03015259
Sponsor's protocol ID
CSP-07-000034
Status last verified
May 2022
First submitted
6 Jan 2017
Last updated
24 Aug 2022
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Budesonide/Formoterol fumarate dihydrate and Symbicort in people with Asthma, run by Kindeva Drug Delivery at 95 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 95 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Serial Forced Expiratory Volume in 1 Second (FEV1) (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03015259.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2022; AzTrials last refreshed its copy on 29 Oct 2026.

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