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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03015259
• Other study ID #: CSP-07-000034
• Status: Completed
• Phase: Phase 3
• Start date: December 29, 2016
• Est. completion date: February 8, 2018

Study information

• Verified date: May 2022
• Source: Kindeva Drug Delivery
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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 information / eligibility

• Status: Completed
• Enrollment: 1762
• Est. completion date: February 8, 2018
• Est. primary completion date: February 8, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ß agonist (SABA)and at least 24 hours after the last dose of long-acting ß 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 ß 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 ß 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 ß-blockers

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Budesonide/Formoterol fumarate dihydrate
Experimental: Treatment 1
• Symbicort
Active Comparator: Treatment 2
• Placebo
Placebo Comparator: Treatment 3

Locations

Country	Name	City	State
United States	Anaheim Clinical Trials LLC	Anaheim	California
United States	Western States Clinical Research Inc	Arvada	Colorado
United States	Allergy Partners of Western North Carolina	Asheville	North Carolina
United States	Chesapeake Clinical Research Inc	Baltimore	Maryland
United States	Paul Shapero's Private Practice	Bangor	Maine
United States	Pioneer Clinical Research LLC	Bellevue	Nebraska
United States	The Asthma and Allergy Center PC	Bellevue	Nebraska
United States	Bethesda Allergy Asthma and Research Center LLC	Bethesda	Maryland
United States	Clinical Research Center of Alabama LLC	Birmingham	Alabama
United States	Ocean Allergy & Respiratory Research Center	Brick	New Jersey
United States	Empirical Medical Research	Canton	Ohio
United States	Colorado Allergy and Asthma Centers PC	Centennial	Colorado
United States	IMMUNOe Research Centers	Centennial	Colorado
United States	Bernstein Clinical Research Center Inc	Cincinnati	Ohio
United States	New Horizons Clinical Research	Cincinnati	Ohio
United States	Saint Francis Sleep Allergy and Lung Institute	Clearwater	Florida
United States	Asthma and Allergy Associates PC	Colorado Springs	Colorado
United States	Clinical Research of the Ozarks INC	Columbia	Missouri
United States	AARA Research Center	Dallas	Texas
United States	Pharmaceutical Research & Consulting Inc	Dallas	Texas
United States	Colorado Allergy and Asthma Centers PC	Denver	Colorado
United States	OK Clinical Research, LLC	Edmond	Oklahoma
United States	Oklahoma Institute of Allergy and Asthma Clinical Research LLC	Edmond	Oklahoma
United States	Western Sky Medical Research	El Paso	Texas
United States	Warren W Pleskow MD	Encinitas	California
United States	Allergy and Asthma Research Group	Eugene	Oregon
United States	Genesis Clinical Research and Consulting LLC	Fall River	Massachusetts
United States	Rapha Institute for Clinical Research	Fayetteville	North Carolina
United States	Southeastern Integrated Medical	Gainesville	Florida
United States	Allergy Asthma and Sinus Center	Greenfield	Wisconsin
United States	ADAC Research	Greenville	South Carolina
United States	Clinical Research Partners LLC	Henrico	Virginia
United States	Pioneer Research Solutions	Houston	Texas
United States	Allergy and Asthma Specialists Medical Group	Huntington Beach	California
United States	Clinical Trial Center LLC	Jenkintown	Pennsylvania
United States	New Phase Research & Development	Knoxville	Tennessee
United States	Innovative Clinical Research Inc	Lafayette	Colorado
United States	Innovative Research of West Florida	Largo	Florida
United States	Clinical Research Consortium Nevada	Las Vegas	Nevada
United States	Analab Clinical Research Inc	Lenexa	Kansas
United States	Little Rock Allergy and Asthma Clinical Research Center	Little Rock	Arkansas
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	Metroplex Pulmonology & Sleep Center	McKinney	Texas
United States	Clinical Research Institute of Southern Oregon PC	Medford	Oregon
United States	Applemed Research Inc	Miami	Florida
United States	Biotech Pharmaceutical Group, LLC	Miami	Florida
United States	Clintex Research Group, Inc	Miami	Florida
United States	Prestige Clinical Research Center Inc	Miami	Florida
United States	Research Institute of South Florida Inc	Miami	Florida
United States	San Marcus Research Clinic Inc	Miami	Florida
United States	Suncoast Research Group LLC	Miami	Florida
United States	Clinical Research Institute, Inc.	Minneapolis	Minnesota
United States	Allergy and Asthma Associates of Southern California, A Medical Group, Inc.	Mission Viejo	California
United States	Montana Medical Research	Missoula	Montana
United States	Central Texas Health Research Corporation	New Braunfels	Texas
United States	Advanced Research Institute Inc	New Port Richey	Florida
United States	National Allergy and Asthma Research, LLC	North Charleston	South Carolina
United States	Infinity Medical Research LLC	North Dartmouth	Massachusetts
United States	Northeast Medical Research Associates Inc	North Dartmouth	Massachusetts
United States	Atlantic Research Center LLC	Ocean Township	New Jersey
United States	Santiago Reyes, MD	Oklahoma City	Oklahoma
United States	Emerald Coast Research Associates	Panama City	Florida
United States	Elite Clinical Studies	Phoenix	Arizona
United States	Allergy Associates Research Center LLC	Portland	Oregon
United States	National Clinical Resources Inc	Provo	Utah
United States	North Carolina Clinical Research	Raleigh	North Carolina
United States	Allied Clinical Research LLC	Reno	Nevada
United States	Asthma and Allergy Center of Chicago Sc	River Forest	Illinois
United States	Integrated Research Group Inc	Riverside	California
United States	Clinical Research of the Ozarks Inc	Rolla	Missouri
United States	Allied Clinical Research LLC	Sacramento	California
United States	Midwest Clinical Research LLC	Saint Louis	Missouri
United States	The Clinical Research Center LLC	Saint Louis	Missouri
United States	Allergy and Asthma Research Center PA	San Antonio	Texas
United States	Quality Assurance Research Center	San Antonio	Texas
United States	Sylvana Research Associates	San Antonio	Texas
United States	Allergy and Asthma Associates of Northern California	San Jose	California
United States	Princeton Center For Clinical Research	Skillman	New Jersey
United States	Montgomery Medical Inc	Smithfield	Pennsylvania
United States	Timber Lane Allergy and Asthma Research LLC	South Burlington	Vermont
United States	S. Carolina Pharmaceutical Research	Spartanburg	South Carolina
United States	Spartanburg Medical Research	Spartanburg	South Carolina
United States	Marycliff Allergy Specialists PS	Spokane	Washington
United States	Toledo Center For Clinical Research	Sylvania	Ohio
United States	Allergy and Asthma Dtc	Tallahassee	Florida
United States	Clinical Research Consortuim Arizona	Tempe	Arizona
United States	Toledo Institute of Clinical Research	Toledo	Ohio
United States	Vital Prospects Clinical Research Institute PC	Tulsa	Oklahoma
United States	Allergy Asthma Research Institute	Waco	Texas
United States	Allergy & Asthma Clinical Research	Walnut Creek	California
United States	Asthma & Allergy Physicians of Rhode Island Clinical Research Institute	Warwick	Rhode Island
United States	Allainz Research Institute Inc	Westminster	California
United States	Rocky Mountain Center for Clinical Research	Wheat Ridge	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Kindeva Drug Delivery

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Number of Participants With Adverse Events	Number of participants reporting at least one adverse event (safety population)	6 Weeks