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

Completed · Phase 3 · Has a placebo group

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT03015259

Run by

Kindeva Drug Delivery

People needed

1762

Starts

2016-12-29

Expected to finish

2018-02-08

Last updated by the study team

2022-08-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Elite Clinical Studies — Phoenix, Arizona, United States
• Clinical Research Consortuim Arizona — Tempe, Arizona, United States
• Little Rock Allergy and Asthma Clinical Research Center — Little Rock, Arkansas, United States
• Anaheim Clinical Trials LLC — Anaheim, California, United States
• Warren W Pleskow MD — Encinitas, California, United States
• Allergy and Asthma Specialists Medical Group — Huntington Beach, California, 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
• Allergy and Asthma Associates of Southern California, A Medical Group, Inc. — Mission Viejo, California, United States
• Integrated Research Group Inc — Riverside, California, United States
• Allied Clinical Research LLC — Sacramento, California, United States
• Allergy and Asthma Associates of Northern California — San Jose, California, United States
• Allergy & Asthma Clinical Research — Walnut Creek, California, United States
• Allainz Research Institute Inc — Westminster, California, United States
• Western States Clinical Research Inc — Arvada, Colorado, United States
• Colorado Allergy and Asthma Centers PC — Centennial, Colorado, United States
• IMMUNOe Research Centers — Centennial, Colorado, United States
• Asthma and Allergy Associates PC — Colorado Springs, Colorado, United States
• Colorado Allergy and Asthma Centers PC — Denver, Colorado, United States
• Innovative Clinical Research Inc — Lafayette, Colorado, United States
• Rocky Mountain Center for Clinical Research — Wheat Ridge, Colorado, United States
• Saint Francis Sleep Allergy and Lung Institute — Clearwater, Florida, United States
• Southeastern Integrated Medical — Gainesville, Florida, United States
• Clinical Research Center of Alabama LLC — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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