Comparing the Efficacy of Symbicort® pMDI and Formoterol Turbuhaler in Reducing Exacerbations in Patients With Cronic Obstructive Pulmonary Disease
NCT ID: NCT02157935
Last Updated: 2017-11-07
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
2026 participants
INTERVENTIONAL
2014-06-27
2016-02-08
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Symbicort pMDI
Symbicort pMDI, budesonide/formoterol, 160/4.5 μg x 2 actuations BID, for oral inhalation
Symbicort
Budesonide/formoterol pMDI, 160/4.5 μg x 2 actuations BID, for oral inhalation, 120 doses
Placebo for Symbicort pMDI
pMDI, aerosol for oral inhalation, placebo, 120 doses
Formoterol Turbuhaler
Formoterol Turbuhaler, 4.5 μg x 2 actuations BID, for oral inhalation
Formoterol turbohaler
Formoterol Turbuhaler 4.5 μg x 2 actuations BID, for oral inhalation, 60 doses
Placebo for Formoterol Turbohaler
PLacebo powder for oral inhalation, 60 doses
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Symbicort
Budesonide/formoterol pMDI, 160/4.5 μg x 2 actuations BID, for oral inhalation, 120 doses
Formoterol turbohaler
Formoterol Turbuhaler 4.5 μg x 2 actuations BID, for oral inhalation, 60 doses
Placebo for Symbicort pMDI
pMDI, aerosol for oral inhalation, placebo, 120 doses
Placebo for Formoterol Turbohaler
PLacebo powder for oral inhalation, 60 doses
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
4\. Current or previous smoker with a smoking history equivalent to 10 or more pack years (1 pack year = 20 cigarettes smoked per day for 1 year).
5\. Post-bronchodilator FEV1/forced vital capacity (FVC) \<0.7 (70%) and FEV1 ≤70% of predicted normal (PN) value.
6\. Documented use of a short-acting inhaled bronchodilator (β2-agonists or anticholinergics) as rescue medication within 6 months prior to study start.
7\. A score of ≥2 on the modified medical research council (MMRC) dyspnea scale. 8. Documented history of ≥1 moderate or severe COPD exacerbation(s) that required treatment with systemic (oral, IM, IV) corticosteroids (a minimum 3 day course of an oral corticosteroid treatment or single depot corticosteroid injection), or hospitalization (defined as an inpatient stay or \>24 hour stay in an observation area in the emergency department or other equivalent facility depending on the country and healthcare system) within 2-52 weeks before Visit 1 (i.e., not within the 14 days prior to Visit 1). A history of an exacerbation treated exclusively with antibiotics will not be considered adequate.
Exclusion Criteria
2. Subjects with significant or unstable ischemic heart disease, arrhythmia, cardiomyopathy, heart failure (including significant cor pulmonale), uncontrolled hypertension as defined by the Investigator, or any other relevant cardiovascular disorder as judged by the Investigator.
3. Known homozygous alpha-1 antitrypsin deficiency.
4. Any significant disease or disorder (e.g., gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results of the study, or the subject's ability to participate in the study.
5. A history of malignancy (except basal cell carcinoma) within the past 5 years.
6. Active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, primary pulmonary hypertension, interstitial lung disease, or other active pulmonary diseases.
7. Subjects who have needed additions or alterations to their usual maintenance or change in formulation of rescue therapy for COPD due to worsening symptoms within the 14 days prior to Visit 1 and up to Visit 3.
8. CXR (frontal and lateral) with suspicion of pneumonia or other condition/abnormality that will require additional investigation/treatment, or put the subject at risk because of participation in the study.
9. Risk factors for pneumonia: immune suppression (HIV, lupus) or other risk for pneumonia (e.g. neurological disorders affecting control of the upper airway, such as Parkinson's disease, myasthenia gravis, etc.).
10. Pneumonia not resolved within 14 days of Visit 1.
11. Moderate or severe COPD exacerbation that has not resolved within 14 days prior to Visit 1 or a moderate or severe COPD exacerbation that occurs between Visit 1 and Visit 2.
12. Long-term oxygen therapy (LTOT) or nocturnal oxygen therapy required for greater than 12 hours a day.
13. Subjects who are currently in the intensive rehabilitation phase or scheduled to begin new participation (intensive rehabilitation phase) in a pulmonary rehabilitation program during the study or have started a new pulmonary rehabilitation program within 60 days of Visit 1. Subjects in the maintenance phase of pulmonary rehabilitation program are not excluded.
14. Treatment with oral, parenteral, or intra-articular corticosteroids within 4 weeks prior to Visit 1.
15. Omalizumab or any other monoclonal or polyclonal antibody therapy taken for any reason within 6 months prior to Visit 1.
40 Years
95 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AstraZeneca
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Gary T Ferguson, MD
Role: PRINCIPAL_INVESTIGATOR
Pulmonary Research Insititute of Southeast Michigan
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Genoa, Ohio, United States
Research Site
Genoa, Ohio, United States
Research Site
Marion, Ohio, United States
Research Site
Marion, Ohio, United States
Research Site
Maumee, Ohio, United States
Research Site
Maumee, Ohio, United States
Research Site
Willoughby, Ohio, United States
Research Site
Willoughby, Ohio, United States
Research Site
Oklahoma City, Oklahoma, United States
Research Site
Oklahoma City, Oklahoma, United States
Research Site
Medford, Oregon, United States
Research Site
Medford, Oregon, United States
Research Site
Portland, Oregon, United States
Research Site
Portland, Oregon, United States
Research Site
Jefferson Hills, Pennsylvania, United States
Research Site
Jefferson Hills, Pennsylvania, United States
Research Site
Scottdale, Pennsylvania, United States
Research Site
Scottdale, Pennsylvania, United States
Research Site
Uniontown, Pennsylvania, United States
Research Site
Uniontown, Pennsylvania, United States
Research Site
Anderson, South Carolina, United States
Research Site
Anderson, South Carolina, United States
Research Site
Easley, South Carolina, United States
Research Site
Easley, South Carolina, United States
Research Site
Greenville, South Carolina, United States
Research Site
Greenville, South Carolina, United States
Research Site
Myrtle Beach, South Carolina, United States
Research Site
Andalusia, Alabama, United States
Research Site
Andalusia, Alabama, United States
Research Site
Birmingham, Alabama, United States
Research Site
Birmingham, Alabama, United States
Research Site
Foley, Alabama, United States
Research Site
Foley, Alabama, United States
Research Site
Jasper, Alabama, United States
Research Site
Jasper, Alabama, United States
Research Site
Mobile, Alabama, United States
Research Site
Mobile, Alabama, United States
Research Site
Chandler, Arizona, United States
Research Site
Chandler, Arizona, United States
Research Site
Flagstaff, Arizona, United States
Research Site
Flagstaff, Arizona, United States
Research Site
Peoria, Arizona, United States
Research Site
Peoria, Arizona, United States
Research Site
Phoenix, Arizona, United States
Research Site
Phoenix, Arizona, United States
Research Site
Phoenix, Arizona, United States
Research Site
Tucson, Arizona, United States
Research Site
Tucson, Arizona, United States
Research Site
Little Rock, Arkansas, United States
Research Site
Little Rock, Arkansas, United States
Research Site
Fresno, California, United States
Research Site
Fresno, California, United States
Research Site
Fullerton, California, United States
Research Site
Fullerton, California, United States
Research Site
Gold River, California, United States
Research Site
Gold River, California, United States
Research Site
Lakewood, California, United States
Research Site
Lakewood, California, United States
Research Site
Los Angeles, California, United States
Research Site
Los Angeles, California, United States
Research Site
Los Angeles, California, United States
Research Site
Newport Beach, California, United States
Research Site
Newport Beach, California, United States
Research Site
Orange, California, United States
Research Site
Orange, California, United States
Research Site
Rancho Mirage, California, United States
Research Site
Rancho Mirage, California, United States
Research Site
San Jose, California, United States
Research Site
San Jose, California, United States
Research Site
Westminster, California, United States
Research Site
Westminster, California, United States
Research Site
Aurora, Colorado, United States
Research Site
Aurora, Colorado, United States
Research Site
Colorado Springs, Colorado, United States
Research Site
Colorado Springs, Colorado, United States
Research Site
Clearwater, Florida, United States
Research Site
Clearwater, Florida, United States
Research Site
Coral Gables, Florida, United States
Research Site
Coral Gables, Florida, United States
Research Site
Fort Lauderdale, Florida, United States
Research Site
Fort Lauderdale, Florida, United States
Research Site
Hialeah, Florida, United States
Research Site
Hialeah, Florida, United States
Research Site
Kissimmee, Florida, United States
Research Site
Kissimmee, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Orlando, Florida, United States
Research Site
Orlando, Florida, United States
Research Site
Ormond Beach, Florida, United States
Research Site
Ormond Beach, Florida, United States
Research Site
Panama City, Florida, United States
Research Site
Panama City, Florida, United States
Research Site
Pensacola, Florida, United States
Research Site
Pensacola, Florida, United States
Research Site
Port Orange, Florida, United States
Research Site
Port Orange, Florida, United States
Research Site
Sarasota, Florida, United States
Research Site
Sarasota, Florida, United States
Research Site
Sebring, Florida, United States
Research Site
Sebring, Florida, United States
Research Site
St. Petersburg, Florida, United States
Research Site
St. Petersburg, Florida, United States
Research Site
Winter Park, Florida, United States
Research Site
Winter Park, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Atlanta, Georgia, United States
Research Site
Atlanta, Georgia, United States
Research Site
Lawrenceville, Georgia, United States
Research Site
Lawrenceville, Georgia, United States
Research Site
Rincon, Georgia, United States
Research Site
Rincon, Georgia, United States
Research Site
Stockbridge, Georgia, United States
Research Site
Stockbridge, Georgia, United States
Research Site
Eagle, Idaho, United States
Research Site
Eagle, Idaho, United States
Research Site
Nampa, Idaho, United States
Research Site
Nampa, Idaho, United States
Research Site
Chicago, Illinois, United States
Research Site
Chicago, Illinois, United States
Research Site
Springfield, Illinois, United States
Research Site
Springfield, Illinois, United States
Research Site
Avon, Indiana, United States
Research Site
Avon, Indiana, United States
Research Site
Brownsburg, Indiana, United States
Research Site
Brownsburg, Indiana, United States
Research Site
Muncie, Indiana, United States
Research Site
Muncie, Indiana, United States
Research Site
Valparaiso, Indiana, United States
Research Site
Valparaiso, Indiana, United States
Research Site
Council Bluffs, Iowa, United States
Research Site
Council Bluffs, Iowa, United States
Research Site
Fort Mitchell, Kentucky, United States
Research Site
Fort Mitchell, Kentucky, United States
Research Site
Hazard, Kentucky, United States
Research Site
Hazard, Kentucky, United States
Research Site
Opelousas, Louisiana, United States
Research Site
Opelousas, Louisiana, United States
Research Site
Shreveport, Louisiana, United States
Research Site
Shreveport, Louisiana, United States
Research Site
Sunset, Louisiana, United States
Research Site
Sunset, Louisiana, United States
Research Site
Bangor, Maine, United States
Research Site
Bangor, Maine, United States
Research Site
Brockton, Massachusetts, United States
Research Site
Brockton, Massachusetts, United States
Research Site
Farmington Hills, Michigan, United States
Research Site
Farmington Hills, Michigan, United States
Research Site
Port Huron, Michigan, United States
Research Site
Port Huron, Michigan, United States
Research Site
Minneapolis, Minnesota, United States
Research Site
Minneapolis, Minnesota, United States
Research Site
Plymouth, Minnesota, United States
Research Site
Plymouth, Minnesota, United States
Research Site
Biloxi, Mississippi, United States
Research Site
Biloxi, Mississippi, United States
Research Site
St Louis, Missouri, United States
Research Site
St Louis, Missouri, United States
Research Site
Billings, Montana, United States
Research Site
Billings, Montana, United States
Research Site
Bellevue, Nebraska, United States
Research Site
Bellevue, Nebraska, United States
Research Site
Lincoln, Nebraska, United States
Research Site
Lincoln, Nebraska, United States
Research Site
Omaha, Nebraska, United States
Research Site
Omaha, Nebraska, United States
Research Site
Marlton, New Jersey, United States
Research Site
Marlton, New Jersey, United States
Research Site
Summit, New Jersey, United States
Research Site
Summit, New Jersey, United States
Research Site
Jackson Heights, New York, United States
Research Site
Jackson Heights, New York, United States
Research Site
Rochester, New York, United States
Research Site
Rochester, New York, United States
Research Site
Charlotte, North Carolina, United States
Research Site
Charlotte, North Carolina, United States
Research Site
Cornelius, North Carolina, United States
Research Site
Cornelius, North Carolina, United States
Research Site
Flat Rock, North Carolina, United States
Research Site
Flat Rock, North Carolina, United States
Research Site
Greensboro, North Carolina, United States
Research Site
Greensboro, North Carolina, United States
Research Site
High Point, North Carolina, United States
Research Site
High Point, North Carolina, United States
Research Site
Cadiz, Ohio, United States
Research Site
Cadiz, Ohio, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Columbus, Ohio, United States
Research Site
Columbus, Ohio, United States
Research Site
Myrtle Beach, South Carolina, United States
Research Site
Old Point Station, South Carolina, United States
Research Site
Old Point Station, South Carolina, United States
Research Site
Spartanburg, South Carolina, United States
Research Site
Spartanburg, South Carolina, United States
Research Site
Boerne, Texas, United States
Research Site
Boerne, Texas, United States
Research Site
Dallas, Texas, United States
Research Site
Dallas, Texas, United States
Research Site
El Paso, Texas, United States
Research Site
El Paso, Texas, United States
Research Site
Houston, Texas, United States
Research Site
Houston, Texas, United States
Research Site
McKinney, Texas, United States
Research Site
McKinney, Texas, United States
Research Site
Plano, Texas, United States
Research Site
Plano, Texas, United States
Research Site
Sealy, Texas, United States
Research Site
Sealy, Texas, United States
Research Site
Midvale, Utah, United States
Research Site
Midvale, Utah, United States
Research Site
Salt Lake City, Utah, United States
Research Site
Salt Lake City, Utah, United States
Research Site
Herndon, Virginia, United States
Research Site
Herndon, Virginia, United States
Research Site
Newport News, Virginia, United States
Research Site
Newport News, Virginia, United States
Research Site
Richmond, Virginia, United States
Research Site
Richmond, Virginia, United States
Research Site
Tacoma, Washington, United States
Research Site
Tacoma, Washington, United States
Research Site
Kingwood, West Virginia, United States
Research Site
Kingwood, West Virginia, United States
Research Site
CABA, , Argentina
Research Site
CABA, , Argentina
Research Site
CABA, , Argentina
Research Site
Corrientes, , Argentina
Research Site
Corrientes, , Argentina
Research Site
Córdoba, , Argentina
Research Site
Córdoba, , Argentina
Research Site
Mendoza, , Argentina
Research Site
Mendoza, , Argentina
Research Site
Nueve de Julio, , Argentina
Research Site
Nueve de Julio, , Argentina
Research Site
Ranelagh, , Argentina
Research Site
Ranelagh, , Argentina
Research Site
San Miguel de Tucumán, , Argentina
Research Site
San Miguel de Tucumán, , Argentina
Research Site
Dupnitsa, , Bulgaria
Research Site
Dupnitsa, , Bulgaria
Research Site
Gotse Delchev, , Bulgaria
Research Site
Gotse Delchev, , Bulgaria
Research Site
Kozloduy, , Bulgaria
Research Site
Kozloduy, , Bulgaria
Research Site
Pazardzhik, , Bulgaria
Research Site
Pazardzhik, , Bulgaria
Research Site
Sandanski, , Bulgaria
Research Site
Sandanski, , Bulgaria
Research Site
Sofia, , Bulgaria
Research Site
Sofia, , Bulgaria
Research Site
Sofia, , Bulgaria
Research Site
Sofia, , Bulgaria
Research Site
Sofia, , Bulgaria
Research Site
Stara Zagora, , Bulgaria
Research Site
Stara Zagora, , Bulgaria
Research Site
Stara Zagora, , Bulgaria
Research Site
Varna, , Bulgaria
Research Site
Varna, , Bulgaria
Research Site
Varna, , Bulgaria
Research Site
Veliko Tarnovo, , Bulgaria
Research Site
Veliko Tarnovo, , Bulgaria
Research Site
Velingrad, , Bulgaria
Research Site
Velingrad, , Bulgaria
Research Site
Santiago, , Chile
Research Site
Santiago, , Chile
Research Site
Santiago, , Chile
Research Site
Santiago, , Chile
Research Site
Beroun, , Czechia
Research Site
Beroun, , Czechia
Research Site
Brandýs nad Labem, , Czechia
Research Site
Brandýs nad Labem, , Czechia
Research Site
Krnov, , Czechia
Research Site
Krnov, , Czechia
Research Site
Liberec, , Czechia
Research Site
Liberec, , Czechia
Research Site
Ostrava, , Czechia
Research Site
Ostrava, , Czechia
Research Site
Ostrava-Poruba, , Czechia
Research Site
Ostrava-Poruba, , Czechia
Research Site
Prague, , Czechia
Research Site
Prague, , Czechia
Research Site
Prague, , Czechia
Research Site
Prague, , Czechia
Research Site
Prague, , Czechia
Research Site
Strakonice, , Czechia
Research Site
Strakonice, , Czechia
Research Site
Žatec, , Czechia
Research Site
Žatec, , Czechia
Research Site
Aschaffenburg, , Germany
Research Site
Aschaffenburg, , Germany
Research Site
Bad Lippspringe, , Germany
Research Site
Bad Lippspringe, , Germany
Research Site
Berlin, , Germany
Research Site
Berlin, , Germany
Research Site
Berlin, , Germany
Research Site
Berlin, , Germany
Research Site
Cologne, , Germany
Research Site
Cologne, , Germany
Research Site
Hanover, , Germany
Research Site
Hanover, , Germany
Research Site
Koblenz, , Germany
Research Site
Koblenz, , Germany
Research Site
Leipzig, , Germany
Research Site
Leipzig, , Germany
Research Site
Leipzig, , Germany
Research Site
Magdeburg, , Germany
Research Site
Magdeburg, , Germany
Research Site
Guadalajara, , Mexico
Research Site
Guadalajara, , Mexico
Research Site
Guadalajara, , Mexico
Research Site
México, , Mexico
Research Site
México, , Mexico
Research Site
Monterrey, , Mexico
Research Site
Monterrey, , Mexico
Research Site
San Juan del Río, , Mexico
Research Site
San Juan del Río, , Mexico
Research Site
Sonora, , Mexico
Research Site
Sonora, , Mexico
Research Site
Aleksandrów Łódzki, , Poland
Research Site
Aleksandrów Łódzki, , Poland
Research Site
Bialystok, , Poland
Research Site
Bialystok, , Poland
Research Site
Bialystok, , Poland
Research Site
Bielsk Podlaski, , Poland
Research Site
Bielsk Podlaski, , Poland
Research Site
Bydgoszcz, , Poland
Research Site
Bydgoszcz, , Poland
Research Site
Kościan, , Poland
Research Site
Kościan, , Poland
Research Site
Krakow, , Poland
Research Site
Krakow, , Poland
Research Site
Lublin, , Poland
Research Site
Lublin, , Poland
Research Site
Ostrowiec Świętokrzyski, , Poland
Research Site
Ostrowiec Świętokrzyski, , Poland
Research Site
Piła, , Poland
Research Site
Piła, , Poland
Research Site
Poznan, , Poland
Research Site
Poznan, , Poland
Research Site
Rzeszów, , Poland
Research Site
Rzeszów, , Poland
Research Site
Skarżysko-Kamienna, , Poland
Research Site
Skarżysko-Kamienna, , Poland
Research Site
Turek, , Poland
Research Site
Turek, , Poland
Research Site
Zabrze, , Poland
Research Site
Zabrze, , Poland
Research Site
Żnin, , Poland
Research Site
Żnin, , Poland
Research Site
San Juan, , Puerto Rico
Research Site
San Juan, , Puerto Rico
Research Site
Cape Town, , South Africa
Research Site
Cape Town, , South Africa
Research Site
Cape Town, , South Africa
Research Site
Cape Town, , South Africa
Research Site
Durban, , South Africa
Research Site
Durban, , South Africa
Research Site
Durban, , South Africa
Research Site
eManzimtoti, , South Africa
Research Site
eManzimtoti, , South Africa
Research Site
Gauteng, , South Africa
Research Site
Gauteng, , South Africa
Research Site
Badalona(Barcelona), , Spain
Research Site
Badalona(Barcelona), , Spain
Research Site
Barcelona, , Spain
Research Site
Barcelona, , Spain
Research Site
Loja (Granada), , Spain
Research Site
Loja (Granada), , Spain
Research Site
Zaragoza, , Spain
Research Site
Zaragoza, , Spain
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Symbicort RISE Revised CSP 3 4 FINAL Redacted
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
D589UC00001
Identifier Type: -
Identifier Source: org_study_id