COPD PatientsPhase 3RISENCT02157935
Comparing the Efficacy of Symbicort® pMDI and Formoterol Turbuhaler in Reducing Exacerbations in Patients With Cronic Obstructive Pulmonary Disease
A Phase 3 study testing Symbicort and Formoterol turbohaler in people with COPD Patients, run by AstraZeneca at 371 sites in 11 countries.
Trial summary
Comparing the efficacy of Symbicort® pMDI and Formoterol Turbuhaler in reducing exacerbations in patients with Chronic Obstructive Pulmonary Disease (COPD). Read more about this study
- Who is it for?
- Ages 40 to 95 years
- Conditions the study is for
- COPD Patients
- What is being tested?
- Symbicort and Formoterol turbohaler
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,026 participants
- Where
- 371 sitesin 11 countries
- Study dates
- 27 Jun 2014to 8 Feb 2016
- 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 40 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 3. A current clinical diagnosis of COPD with COPD symptoms for more than 1 year, according to the GOLD guidelines.
- 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.
Who cannot join
- A history of asthma at or after 18 years of age.
- 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.
- Known homozygous alpha-1 antitrypsin deficiency.
- 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.
- A history of malignancy (except basal cell carcinoma) within the past 5 years.
- Active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, primary pulmonary hypertension, interstitial lung disease, or other active pulmonary diseases.
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- 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.
- 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.
- 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.).
- Pneumonia not resolved within 14 days of Visit 1.
- 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.
- Long-term oxygen therapy (LTOT) or nocturnal oxygen therapy required for greater than 12 hours a day.
- 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.
- Treatment with oral, parenteral, or intra-articular corticosteroids within 4 weeks prior to Visit 1.
- Omalizumab or any other monoclonal or polyclonal antibody therapy taken for any reason within 6 months prior to Visit 1.
Trial locations and contacts
371 sites in 11 countries.
371 sites in 11 countries
United States224 sites
Research Site
Andalusia, Alabama, 36420
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Andalusia, Alabama
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Anderson, South Carolina, 29621
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Anderson, South Carolina
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Atlanta, Georgia, 30331
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Atlanta, Georgia, 30342
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Atlanta, Georgia
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Aurora, Colorado, 80014
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Aurora, Colorado
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Avon, Indiana, 46123
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Avon, Indiana
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Bangor, Maine, 04401
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Bangor, Maine
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Bellevue, Nebraska, 68005
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Bellevue, Nebraska
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Billings, Montana, 59102
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Billings, Montana
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Biloxi, Mississippi, 39531
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Biloxi, Mississippi
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Birmingham, Alabama, 35209
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Birmingham, Alabama
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Boerne, Texas, 78006
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Boerne, Texas
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Brockton, Massachusetts, 02301
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Brockton, Massachusetts
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Brownsburg, Indiana, 46112
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Brownsburg, Indiana
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Cadiz, Ohio, 43907
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Cadiz, Ohio
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Chandler, Arizona, 85224
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Chandler, Arizona
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Charlotte, North Carolina, 28204
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Charlotte, North Carolina
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Chicago, Illinois, 60607
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Chicago, Illinois
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Cincinnati, Ohio, 45231
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Cincinnati, Ohio, 45242
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Cincinnati, Ohio
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Clearwater, Florida, 33756
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Clearwater, Florida
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Colorado Springs, Colorado, 80909
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Colorado Springs, Colorado
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Columbus, Ohio, 43214
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Columbus, Ohio
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Coral Gables, Florida, 33134
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Coral Gables, Florida
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Cornelius, North Carolina, 28031
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Cornelius, North Carolina
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Council Bluffs, Iowa, 51503
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Council Bluffs, Iowa
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Dallas, Texas, 75225
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Dallas, Texas
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Eagle, Idaho, 83616
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Eagle, Idaho
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Easley, South Carolina, 29640
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Easley, South Carolina
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El Paso, Texas, 79903
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El Paso, Texas
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Farmington Hills, Michigan, 48336
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Farmington Hills, Michigan
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Flagstaff, Arizona, 86001
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Flagstaff, Arizona
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Flat Rock, North Carolina, 28731
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Flat Rock, North Carolina
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Foley, Alabama, 36535
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Foley, Alabama
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Fort Lauderdale, Florida, 33334
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Fort Lauderdale, Florida
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Fort Mitchell, Kentucky, 41017
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Fort Mitchell, Kentucky
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Fresno, California, 93702
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Fresno, California
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Fullerton, California, 92835
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Fullerton, California
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Genoa, Ohio, 43430
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Genoa, Ohio
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Gold River, California, 95670
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Gold River, California
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Greensboro, North Carolina, 27408
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Greensboro, North Carolina
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Greenville, South Carolina, 29615
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Greenville, South Carolina
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Hazard, Kentucky, 41701
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Hazard, Kentucky
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Herndon, Virginia, 20171
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Herndon, Virginia
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Hialeah, Florida, 33013
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Hialeah, Florida
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High Point, North Carolina, 27262
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High Point, North Carolina
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Houston, Texas, 77034
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Houston, Texas
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Jackson Heights, New York, 11372
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Jackson Heights, New York
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Jasper, Alabama, 35501
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Jasper, Alabama
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Jefferson Hills, Pennsylvania, 15025
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Jefferson Hills, Pennsylvania
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Kingwood, West Virginia, 26357
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Kingwood, West Virginia
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Kissimmee, Florida, 34741
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Kissimmee, Florida
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Lakewood, California, 90712
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Lakewood, California
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Lawrenceville, Georgia, 30046
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Lawrenceville, Georgia
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Lincoln, Nebraska, 68510
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Lincoln, Nebraska
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Little Rock, Arkansas, 72204
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Little Rock, Arkansas
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Los Angeles, California, 90025
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Los Angeles, California, 90048
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Los Angeles, California
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Marion, Ohio, 43302
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Marion, Ohio
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Marlton, New Jersey, 08053
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Marlton, New Jersey
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Maumee, Ohio, 43537
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Maumee, Ohio
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McKinney, Texas, 75069
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McKinney, Texas
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Medford, Oregon, 97504
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Medford, Oregon
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Miami, Florida, 33186
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Miami, Florida
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Midvale, Utah, 84047
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Midvale, Utah
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Minneapolis, Minnesota, 55402
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Minneapolis, Minnesota
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Mobile, Alabama, 36608
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Mobile, Alabama
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Muncie, Indiana, 47304
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Muncie, Indiana
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Myrtle Beach, South Carolina, 29588
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Myrtle Beach, South Carolina
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Nampa, Idaho, 83687
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Nampa, Idaho
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Newport Beach, California, 92663
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Newport Beach, California
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Newport News, Virginia, 23606
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Newport News, Virginia
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Oklahoma City, Oklahoma, 73103
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Oklahoma City, Oklahoma
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Old Point Station, South Carolina, 29707
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Old Point Station, South Carolina
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Omaha, Nebraska, 68114
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Omaha, Nebraska
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Opelousas, Louisiana, 70570
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Opelousas, Louisiana
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Orange, California, 92868
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Orange, California
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Orlando, Florida, 32825
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Orlando, Florida
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Ormond Beach, Florida, 32174
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Ormond Beach, Florida
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Panama City, Florida, 32405
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Panama City, Florida
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Pensacola, Florida, 32503
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Pensacola, Florida
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Peoria, Arizona, 85381
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Peoria, Arizona
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Phoenix, Arizona, 85018
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Phoenix, Arizona, 85050
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Plano, Texas, 75093
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Plano, Texas
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Plymouth, Minnesota, 55441
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Plymouth, Minnesota
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Port Huron, Michigan, 48060
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Port Huron, Michigan
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Port Orange, Florida, 32129
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Port Orange, Florida
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Portland, Oregon, 97202
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Portland, Oregon
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Rancho Mirage, California, 92270
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Rancho Mirage, California
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Richmond, Virginia, 23225
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Richmond, Virginia
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Rincon, Georgia, 31326
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Rincon, Georgia
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Rochester, New York, 14618
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Rochester, New York
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Salt Lake City, Utah, 84124
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Salt Lake City, Utah
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San Jose, California, 95117
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San Jose, California
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Sarasota, Florida, 34239
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Sarasota, Florida
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Scottdale, Pennsylvania, 15683
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Scottdale, Pennsylvania
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Sealy, Texas, 77474
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Sealy, Texas
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Sebring, Florida, 33870
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Sebring, Florida
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Shreveport, Louisiana, 71104
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Shreveport, Louisiana
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Spartanburg, South Carolina, 29303
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Spartanburg, South Carolina
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Springfield, Illinois, 62704
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Springfield, Illinois
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St Louis, Missouri, 63141
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St Louis, Missouri
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St. Petersburg, Florida, 33710
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St. Petersburg, Florida
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Stockbridge, Georgia, 30281
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Stockbridge, Georgia
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Summit, New Jersey, 07901
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Summit, New Jersey
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Sunset, Louisiana, 70584
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Sunset, Louisiana
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Tacoma, Washington, 98405
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Tacoma, Washington
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Tucson, Arizona, 85724
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Tucson, Arizona
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Uniontown, Pennsylvania, 15401
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Uniontown, Pennsylvania
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Valparaiso, Indiana, 46383
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Valparaiso, Indiana
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Westminster, California, 92683
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Westminster, California
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Willoughby, Ohio, 44094
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Willoughby, Ohio
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Winter Park, Florida, 32789-4681
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Winter Park, Florida
Poland31 sites
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Aleksandrów Łódzki, 95-070
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Aleksandrów Łódzki
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Bialystok, 15-003
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Bialystok, 15-430
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Bialystok
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Bielsk Podlaski, 17-100
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Bielsk Podlaski
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Bydgoszcz, 85-231
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Bydgoszcz
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Kościan, 64-000
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Kościan
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Krakow, 31-209
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Krakow
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Lublin, 20-709
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Lublin
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Ostrowiec Świętokrzyski, 27-400
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Ostrowiec Świętokrzyski
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Piła, 64-920
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Piła
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Poznan, 60-685
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Poznan
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Rzeszów, 35-205
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Rzeszów
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Skarżysko-Kamienna, 26-110
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Skarżysko-Kamienna
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Turek, 62-700
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Turek
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Zabrze, 41-800
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Zabrze
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Żnin, 88-400
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Żnin
Bulgaria25 sites
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Dupnitsa, 2600
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Dupnitsa
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Gotse Delchev, 2900
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Gotse Delchev
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Kozloduy, 3320
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Kozloduy
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Pazardzhik, 4400
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Pazardzhik
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Sandanski, 2800
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Sandanski
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Sofia, 1404
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Sofia, 1407
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Sofia, 1606
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Sofia, 1618
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Sofia
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Stara Zagora, 6000
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Stara Zagora, 6003
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Stara Zagora
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Varna, 9000
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Varna, 9010
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Varna
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Veliko Tarnovo, 5000
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Veliko Tarnovo
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Velingrad, 4600
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Velingrad
Czechia21 sites
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Beroun, 266 00
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Beroun
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Brandýs nad Labem, 250 01
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Brandýs nad Labem
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Krnov, 794 01
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Krnov
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Liberec, 460 01
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Liberec
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Ostrava, 728 80
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Ostrava
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Ostrava-Poruba, 708 68
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Ostrava-Poruba
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Prague, 108 00
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Prague, 150 00
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Prague, 158 00
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Prague, 163 00
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Prague
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Strakonice, 38601
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Strakonice
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Žatec, 43801
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Žatec
Germany19 sites
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Aschaffenburg, 63739
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Aschaffenburg
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Bad Lippspringe, 33175
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Bad Lippspringe
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Berlin, 10119
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Berlin, 10787
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Berlin, 13187
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Berlin
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Cologne, 51069
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Cologne
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Hanover, 30173
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Hanover
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Koblenz, 56068
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Koblenz
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Leipzig, 04207
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Leipzig, 04275
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Leipzig
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Magdeburg, 39120
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Magdeburg
Argentina15 sites
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CABA, 1426
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CABA, C1425BEN
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CABA
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Córdoba, X5003DCE
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Córdoba
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Corrientes, 3400
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Corrientes
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Mendoza, 5500
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Mendoza
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Nueve de Julio, B6500EZL
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Nueve de Julio
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Ranelagh, 1886
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Ranelagh
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San Miguel de Tucumán, 4000
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San Miguel de Tucumán
Mexico11 sites
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Guadalajara, 44200
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Guadalajara, 44670
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Guadalajara
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México, 14050
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México
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Monterrey, 64460
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Monterrey
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San Juan del Río, 76800
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San Juan del Río
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Sonora, 83000
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Sonora
South Africa11 sites
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Cape Town, 1730
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Cape Town, 7700
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Cape Town, 7764
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Cape Town
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Durban, 4001
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Durban, 4301
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Durban
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eManzimtoti, 4126
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eManzimtoti
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Gauteng, 2193
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Gauteng
Spain8 sites
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Badalona(Barcelona), 08916
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Badalona(Barcelona)
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Barcelona, 08003
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Barcelona
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Loja (Granada), 18300
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Loja (Granada)
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Zaragoza, 50009
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Zaragoza
Chile4 sites
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Santiago, 7500698
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Santiago, 8380456
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Santiago, 8910131
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Santiago
About this study
Official title: A Phase IIIB, 6-Month, Double-blind, Double-dummy, Randomized, Parallel-group, Multicenter Exacerbation Study of Symbicort® Pressurized Metered-Dose Inhaler (pMDI) 160/4.5 μg x 2 Actuations Twice-daily Compared to Formoterol Turbuhaler 4.5 μg x 2 Inhalations Twice-daily in Cronic Obstructive Pulmonary Disease (COPD) Patients.
Comparing the efficacy of Symbicort® pMDI and Formoterol Turbuhaler in reducing exacerbations in patients with Chronic Obstructive Pulmonary Disease (COPD).
Read the detailed description
A Phase IIIB, 6-Month, Double-blind, Double-dummy, Randomized, Parallel-group, Multicenter Exacerbation Study of Symbicort® pMDI 160/4.5 μg x 2 Actuations Twice-daily Compared to Formoterol Turbuhaler 4.5 μg x 2 Inhalations Twice-daily in COPD Patients.
- Conditions
- COPD Patients
- Being tested
- Symbicort, Formoterol turbohaler, Placebo for Symbicort pMDI, Placebo for Formoterol Turbohaler
- Keywords
- COPD, turbuhaler, pMDI
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SymbicortDrug
Budesonide/formoterol pMDI, 160/4.5 μg x 2 actuations BID, for oral inhalation, 120 doses
Formoterol turbohalerDrug
Formoterol Turbuhaler 4.5 μg x 2 actuations BID, for oral inhalation, 60 doses
Placebo for Symbicort pMDIOther
pMDI, aerosol for oral inhalation, placebo, 120 doses
Placebo for Formoterol TurbohalerOther
PLacebo powder for oral inhalation, 60 doses
| Study group | Role | What they receive |
|---|---|---|
| Symbicort pMDI | Active comparator | Symbicort pMDI, budesonide/formoterol, 160/4.5 μg x 2 actuations BID, for oral inhalation Receives: Drug: Symbicort; Other: Placebo for Symbicort pMDI |
| Formoterol Turbuhaler | Active comparator | Formoterol Turbuhaler, 4.5 μg x 2 actuations BID, for oral inhalation Receives: Drug: Formoterol turbohaler; Other: Placebo for Formoterol Turbohaler |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Rate of Moderate and Severe COPD Exacerbations Defined as: Worsening of ≥2 Major Symptoms or Worsening of 1 Major Symptom Together With ≥1 Minor Symptom for ≥2 Consecutive Days
The annual COPD exacerbation rate was analyzed and compared between two arms.
Annual exacerbation rate for each subject is defined as number of exacerbations divided by duration of randomized treatment period in years.
The annual COPD exacerbation rate of Symbicort group was compared with annual rate of Formoterol group. The rate ratio of Symbicort vs. Formoteroal was assessed by a negative binomial model.
Exacerbations, that met the modified Anthonisen criteria and duration ≥2 days were classified as moderate and severe exacerbations.
Moderate exacerbation: treatment of symptoms with systemic corticosteroids (≥3 days) and/or antibiotics.
Severe exacerbation: symptoms that require hospitalization (including >24 hours in ED/urgent care setting).
Measured: Randomization at Week 0 to End of Treatment (EoT) W 26
Secondary outcomes (5)
Number of Patients With Moderate or Severe COPD Exacerbation.
The number of patients who developed moderate or severe COPD exacerbation during treatment period were reported. Cox proportional hazards regression model was fitted to data to compare the two treatment arms .
The hazard ratio and 95% CI were estimated.
Measured: From randomzation to EoT W 26
St. George's Respiratory Questionnaire (SGRQ)
SGRQ is a standardized, self-administered tool for measuring impaired health and perceived wellbeing in respiratory diseases; a validated electronic version of the questionnaire in the relevant validated languages was used in this study.
The questionnaire contains 50 items divided into three dimensions (Symptoms, Activity and Impact).
Each of the three dimensions of the questionnaire is scored separately in the range from 0 to 100:
zero (0) score indicating no impairment of quality of life.
The total SGRQ score ranging from 0 to 100 is a summary score utilizing responses to all items calculated using weights attached to each item of the questionnaire.
Higher scores indicate poorer health and change of 4 units in the SGRQ has been determined to be the threshold for a clinically relevant change in health status.
The change from baseline was statistically summarized and compared between two arms in a mixed model.
Measured: From Run-in W -4 to EoT W 26
Pre-dose/Pre-bronchodilator FEV1 at the Study Site
FEV1 from pre-dose spirometry is a measurement of lung function. The change from baseline on pre-dose FEV1 was summarized and compared between Symbicort and Formoterol groups using a mixed model.
Measured: From Run-in W -4 to EoT W 26
Total Rescue Medication Use (Average Puffs/Day)
Use of rescue medication is a measure of symptoms that need to be treated with a short-acting bronchodilator.
The average daily use across the observation period was used for analysis. Change from baseline was summarized and compared between two arms using a mixed model.
Measured: From Run-in W -4 to EoT W 26
Nights With Awakening Due to COPD
Nighttime awakening due to COPD symptoms correspond to the severity of nocturnal symptoms from COPD.
The average number of awakening per night over the treatment period was analyzed. It was derived as the number of night with awakening divided by the total number of nights with data in the recording period. Change from baseline period on awakening was summarized and compared between two arms using a mixed model.
Measured: From Run-in W -4 to EoT W 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2014 (estimated)
- Study start27 Jun 2014
- Primary completion8 Feb 2016
- Study completion8 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COPD PatientsStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2,026 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gary T Ferguson, MD, Principal investigator, Pulmonary Research Insititute of Southeast Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02157935
- Sponsor's protocol ID
- D589UC00001
- Acronym
- RISE
- Status last verified
- Oct 2017
- First submitted
- 5 Jun 2014
- Last updated
- 7 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIIB, 6-Month, Double-blind, Double-dummy, Randomized, Parallel-group, Multicenter Exacerbation Study of Symbicort® Pressurized Metered-Dose Inhaler (pMDI) 160/4.5 μg x 2 Actuations Twice-daily Compared to Formoterol Turbuhaler 4.5 μg x 2 Inhalations Twice-daily in Cronic Obstructive Pulmonary Disease (COPD) Patients.
- ClinicalTrials.gov ID
- NCT02157935
- Acronym / sponsor ID
- RISE / D589UC00001
- Conditions
- COPD Patients
- Keywords
- COPD, turbuhaler, pMDI
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,026 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 27 Jun 2014 (actual)
- Primary completion
- 8 Feb 2016 (actual)
- Study completion
- 8 Feb 2016 (actual)
- First posted
- 6 Jun 2014 (estimated)
- Results
- Posted 12 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparing the efficacy of Symbicort® pMDI and Formoterol Turbuhaler in reducing exacerbations in patients with Chronic Obstructive Pulmonary Disease (COPD).
Detailed description
A Phase IIIB, 6-Month, Double-blind, Double-dummy, Randomized, Parallel-group, Multicenter Exacerbation Study of Symbicort® pMDI 160/4.5 μg x 2 Actuations Twice-daily Compared to Formoterol Turbuhaler 4.5 μg x 2 Inhalations Twice-daily in COPD Patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Symbicort pMDI | Active comparator | Drug: Symbicort, Other: Placebo for Symbicort pMDISymbicort pMDI, budesonide/formoterol, 160/4.5 μg x 2 actuations BID, for oral inhalation |
| Formoterol Turbuhaler | Active comparator | Drug: Formoterol turbohaler, Other: Placebo for Formoterol TurbohalerFormoterol Turbuhaler, 4.5 μg x 2 actuations BID, for oral inhalation |
Who may qualify
- Ages
- 40 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 3. A current clinical diagnosis of COPD with COPD symptoms for more than 1 year, according to the GOLD guidelines.
- 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.
Key exclusion criteria (15 listed)
- A history of asthma at or after 18 years of age.
- 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.
- Known homozygous alpha-1 antitrypsin deficiency.
- 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.
- A history of malignancy (except basal cell carcinoma) within the past 5 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SymbicortBudesonide/formoterol pMDI, 160/4.5 μg x 2 actuations BID, for oral inhalation, 120 doses | Drug | Symbicort pMDI |
| Formoterol turbohalerFormoterol Turbuhaler 4.5 μg x 2 actuations BID, for oral inhalation, 60 doses | Drug | Formoterol Turbuhaler |
| Placebo for Symbicort pMDIpMDI, aerosol for oral inhalation, placebo, 120 doses | Other | Symbicort pMDI |
| Placebo for Formoterol TurbohalerPLacebo powder for oral inhalation, 60 doses | Other | Formoterol Turbuhaler |
Primary outcome
The Rate of Moderate and Severe COPD Exacerbations Defined as: Worsening of ≥2 Major Symptoms or Worsening of 1 Major Symptom Together With ≥1 Minor Symptom for ≥2 Consecutive Days
Time frame: Randomization at Week 0 to End of Treatment (EoT) W 26
The annual COPD exacerbation rate was analyzed and compared between two arms. Annual exacerbation rate for each subject is defined as number of exacerbations divided by duration of randomized treatment period in years. The annual COPD exacerbation rate of Symbicort group was compared with annual rate of Formoterol group. The rate ratio of Symbicort vs. Formoteroal was assessed by a negative binomial model. Exacerbations, that met the modified Anthonisen criteria and duration ≥2 days were classified as moderate and severe exacerbations. Moderate exacerbation: treatment of symptoms with systemic corticosteroids (≥3 days) and/or antibiotics. Severe exacerbation: symptoms that require hospitalization (including >24 hours in ED/urgent care setting).
5 secondary outcomes
Number of Patients With Moderate or Severe COPD Exacerbation.
Time frame: From randomzation to EoT W 26
St. George's Respiratory Questionnaire (SGRQ)
Time frame: From Run-in W -4 to EoT W 26
Pre-dose/Pre-bronchodilator FEV1 at the Study Site
Time frame: From Run-in W -4 to EoT W 26
Total Rescue Medication Use (Average Puffs/Day)
Time frame: From Run-in W -4 to EoT W 26
Nights With Awakening Due to COPD
Time frame: From Run-in W -4 to EoT W 26
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Symbicort RISE Revised CSP 3 4 FINAL RedactedLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary T Ferguson, MD principal investigator
Pulmonary Research Insititute of Southeast Michigan
371 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Symbicort and Formoterol turbohaler in people with COPD Patients, run by AstraZeneca at 371 sites in 11 countries.
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 5 inclusion and 15 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 7 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 371 sites in United States, Poland, Bulgaria, Czechia, Germany and 6 more countries. 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. 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 12 Jun 2017). 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?
The Rate of Moderate and Severe COPD Exacerbations Defined as: Worsening of ≥2 Major Symptoms or Worsening of 1 Major Symptom Together With ≥1 Minor Symptom for ≥2 Consecutive Days (time frame: Randomization at Week 0 to End of Treatment (EoT) W 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Nov 2017.