Comparing the Efficacy of Symbicort® pMDI and Formoterol Turbuhaler in Reducing Exacerbations in Patients With Cronic Obstructive Pulmonary Disease (RISE)

October 5, 2017 updated by: AstraZeneca

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).

Study Overview

Status

Completed

Conditions

COPD Patients

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

2026

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Caba, Argentina
    - Research Site
  - Caba, Argentina, C1425BEN
    - Research Site
  - Caba, Argentina, 1426
    - Research Site
  - Corrientes, Argentina
    - Research Site
  - Corrientes, Argentina, 3400
    - Research Site
  - Córdoba, Argentina, X5003DCE
    - Research Site
  - Córdoba, Argentina
    - Research Site
  - Mendoza, Argentina
    - Research Site
  - Mendoza, Argentina, 5500
    - Research Site
  - Nueve de julio, Argentina, B6500EZL
    - Research Site
  - Nueve de julio, Argentina
    - Research Site
  - Ranelagh, Argentina, 1886
    - Research Site
  - Ranelagh, Argentina
    - Research Site
  - San Miguel de Tucuman, Argentina
    - Research Site
  - San Miguel de Tucuman, Argentina, 4000
    - Research Site
Bulgaria
- - Dupnitsa, Bulgaria
    - Research Site
  - Dupnitsa, Bulgaria, 2600
    - Research Site
  - Gotse Delchev, Bulgaria, 2900
    - Research Site
  - Gotse Delchev, Bulgaria
    - Research Site
  - Kozloduy, Bulgaria, 3320
    - Research Site
  - Kozloduy, Bulgaria
    - Research Site
  - Pazardzhik, Bulgaria
    - Research Site
  - Pazardzhik, Bulgaria, 4400
    - Research Site
  - Sandanski, Bulgaria
    - Research Site
  - Sandanski, Bulgaria, 2800
    - Research Site
  - Sofia, Bulgaria
    - Research Site
  - Sofia, Bulgaria, 1407
    - Research Site
  - Sofia, Bulgaria, 1606
    - Research Site
  - Sofia, Bulgaria, 1404
    - Research Site
  - Sofia, Bulgaria, 1618
    - Research Site
  - Stara Zagora, Bulgaria
    - Research Site
  - Stara Zagora, Bulgaria, 6003
    - Research Site
  - Stara Zagora, Bulgaria, 6000
    - Research Site
  - Varna, Bulgaria
    - Research Site
  - Varna, Bulgaria, 9000
    - Research Site
  - Varna, Bulgaria, 9010
    - Research Site
  - Veliko Tarnovo, Bulgaria
    - Research Site
  - Veliko Tarnovo, Bulgaria, 5000
    - Research Site
  - Velingrad, Bulgaria
    - Research Site
  - Velingrad, Bulgaria, 4600
    - Research Site
Chile
- - Santiago, Chile
    - Research Site
  - Santiago, Chile, 8380456
    - Research Site
  - Santiago, Chile, 7500698
    - Research Site
  - Santiago, Chile, 8910131
    - Research Site
Czechia
- - Beroun, Czechia, 266 00
    - Research Site
  - Beroun, Czechia
    - Research Site
  - Brandys nad Labem, Czechia, 250 01
    - Research Site
  - Brandys nad Labem, Czechia
    - Research Site
  - Krnov, Czechia, 794 01
    - Research Site
  - Krnov, Czechia
    - Research Site
  - Liberec, Czechia
    - Research Site
  - Liberec, Czechia, 460 01
    - Research Site
  - Ostrava, Czechia
    - Research Site
  - Ostrava, Czechia, 728 80
    - Research Site
  - Ostrava-Poruba, Czechia, 708 68
    - Research Site
  - Ostrava-Poruba, Czechia
    - Research Site
  - Praha 10, Czechia
    - Research Site
  - Praha 10, Czechia, 108 00
    - Research Site
  - Praha 5, Czechia, 158 00
    - Research Site
  - Praha 5, Czechia
    - Research Site
  - Praha 5, Czechia, 150 00
    - Research Site
  - Praha 6, Czechia, 163 00
    - Research Site
  - Praha 6, Czechia
    - Research Site
  - Strakonice, Czechia, 38601
    - Research Site
  - Strakonice, Czechia
    - Research Site
  - Zatec, Czechia, 43801
    - Research Site
  - Zatec, Czechia
    - Research Site
Germany
- - Aschaffenburg, Germany
    - Research Site
  - Aschaffenburg, Germany, 63739
    - Research Site
  - Bad Lippspringe, Germany
    - Research Site
  - Bad Lippspringe, Germany, 33175
    - Research Site
  - Berlin, Germany
    - Research Site
  - Berlin, Germany, 10119
    - Research Site
  - Berlin, Germany, 10787
    - Research Site
  - Berlin, Germany, 13187
    - Research Site
  - Hannover, Germany
    - Research Site
  - Hannover, Germany, 30173
    - Research Site
  - Koblenz, Germany, 56068
    - Research Site
  - Koblenz, Germany
    - Research Site
  - Köln, Germany
    - Research Site
  - Köln, Germany, 51069
    - Research Site
  - Leipzig, Germany
    - Research Site
  - Leipzig, Germany, 04207
    - Research Site
  - Leipzig, Germany, 04275
    - Research Site
  - Magdeburg, Germany
    - Research Site
  - Magdeburg, Germany, 39120
    - Research Site
Mexico
- - Guadalajara, Mexico
    - Research Site
  - Guadalajara, Mexico, 44670
    - Research Site
  - Guadalajara, Mexico, 44200
    - Research Site
  - Mexico, Mexico
    - Research Site
  - Mexico, Mexico, 14050
    - Research Site
  - Monterrey, Mexico
    - Research Site
  - Monterrey, Mexico, 64460
    - Research Site
  - San Juan del Rio, Mexico, 76800
    - Research Site
  - San Juan del Rio, Mexico
    - Research Site
  - Sonora, Mexico, 83000
    - Research Site
  - Sonora, Mexico
    - Research Site
Poland
- - Aleksandrów Łódzki, Poland, 95-070
    - Research Site
  - Aleksandrów Łódzki, Poland
    - Research Site
  - Białystok, Poland
    - Research Site
  - Białystok, Poland, 15-003
    - Research Site
  - Białystok, Poland, 15-430
    - Research Site
  - Bielsk Podlaski, Poland, 17-100
    - Research Site
  - Bielsk Podlaski, Poland
    - Research Site
  - Bydgoszcz, Poland
    - Research Site
  - Bydgoszcz, Poland, 85-231
    - Research Site
  - Kościan, Poland
    - Research Site
  - Kościan, Poland, 64-000
    - Research Site
  - Kraków, Poland
    - Research Site
  - Kraków, Poland, 31-209
    - Research Site
  - Lublin, Poland
    - Research Site
  - Lublin, Poland, 20-709
    - Research Site
  - Ostrowiec Świętokrzyski, Poland, 27-400
    - Research Site
  - Ostrowiec Świętokrzyski, Poland
    - Research Site
  - Pila, Poland, 64-920
    - Research Site
  - Pila, Poland
    - Research Site
  - Poznań, Poland
    - Research Site
  - Poznań, Poland, 60-685
    - Research Site
  - Rzeszów, Poland
    - Research Site
  - Rzeszów, Poland, 35-205
    - Research Site
  - Skarżysko-Kamienna, Poland, 26-110
    - Research Site
  - Skarżysko-Kamienna, Poland
    - Research Site
  - Turek, Poland
    - Research Site
  - Turek, Poland, 62-700
    - Research Site
  - Zabrze, Poland
    - Research Site
  - Zabrze, Poland, 41-800
    - Research Site
  - Żnin, Poland, 88-400
    - Research Site
  - Żnin, Poland
    - Research Site
Puerto Rico
- - San Juan, Puerto Rico, 00927
    - Research Site
  - San Juan, Puerto Rico
    - Research Site
South Africa
- - Amanzimtoti, South Africa, 4126
    - Research Site
  - Amanzimtoti, South Africa
    - Research Site
  - Cape Town, South Africa
    - Research Site
  - Cape Town, South Africa, 7700
    - Research Site
  - Cape Town, South Africa, 7764
    - Research Site
  - Cape Town, South Africa, 1730
    - Research Site
  - Durban, South Africa
    - Research Site
  - Durban, South Africa, 4001
    - Research Site
  - Durban, South Africa, 4301
    - Research Site
  - Gauteng, South Africa, 2193
    - Research Site
  - Gauteng, South Africa
    - Research Site
Spain
- - Badalona(Barcelona), Spain, 08916
    - Research Site
  - Badalona(Barcelona), Spain
    - Research Site
  - Barcelona, Spain
    - Research Site
  - Barcelona, Spain, 08003
    - Research Site
  - Loja (Granada), Spain, 18300
    - Research Site
  - Loja (Granada), Spain
    - Research Site
  - Zaragoza, Spain, 50009
    - Research Site
  - Zaragoza, Spain
    - Research Site
United States
- Alabama
  - Andalusia, Alabama, United States, 36420
    - Research Site
  - Andalusia, Alabama, United States
    - Research Site
  - Birmingham, Alabama, United States, 35209
    - Research Site
  - Birmingham, Alabama, United States
    - Research Site
  - Foley, Alabama, United States
    - Research Site
  - Foley, Alabama, United States, 36535
    - Research Site
  - Jasper, Alabama, United States, 35501
    - Research Site
  - Jasper, Alabama, United States
    - Research Site
  - Mobile, Alabama, United States
    - Research Site
  - Mobile, Alabama, United States, 36608
    - Research Site
- Arizona
  - Chandler, Arizona, United States
    - Research Site
  - Chandler, Arizona, United States, 85224
    - Research Site
  - Flagstaff, Arizona, United States, 86001
    - Research Site
  - Flagstaff, Arizona, United States
    - Research Site
  - Peoria, Arizona, United States
    - Research Site
  - Peoria, Arizona, United States, 85381
    - Research Site
  - Phoenix, Arizona, United States
    - Research Site
  - Phoenix, Arizona, United States, 85018
    - Research Site
  - Phoenix, Arizona, United States, 85050
    - Research Site
  - Tucson, Arizona, United States, 85724
    - Research Site
  - Tucson, Arizona, United States
    - Research Site
- Arkansas
  - Little Rock, Arkansas, United States
    - Research Site
  - Little Rock, Arkansas, United States, 72204
    - Research Site
- California
  - Fresno, California, United States
    - Research Site
  - Fresno, California, United States, 93702
    - Research Site
  - Fullerton, California, United States
    - Research Site
  - Fullerton, California, United States, 92835
    - Research Site
  - Gold River, California, United States, 95670
    - Research Site
  - Gold River, California, United States
    - Research Site
  - Lakewood, California, United States
    - Research Site
  - Lakewood, California, United States, 90712
    - Research Site
  - Los Angeles, California, United States, 90025
    - Research Site
  - Los Angeles, California, United States
    - Research Site
  - Los Angeles, California, United States, 90048
    - Research Site
  - Newport Beach, California, United States, 92663
    - Research Site
  - Newport Beach, California, United States
    - Research Site
  - Orange, California, United States
    - Research Site
  - Orange, California, United States, 92868
    - Research Site
  - Rancho Mirage, California, United States
    - Research Site
  - Rancho Mirage, California, United States, 92270
    - Research Site
  - San Jose, California, United States
    - Research Site
  - San Jose, California, United States, 95117
    - Research Site
  - Westminster, California, United States, 92683
    - Research Site
  - Westminster, California, United States
    - Research Site
- Colorado
  - Aurora, Colorado, United States
    - Research Site
  - Aurora, Colorado, United States, 80014
    - Research Site
  - Colorado Springs, Colorado, United States
    - Research Site
  - Colorado Springs, Colorado, United States, 80909
    - Research Site
- Florida
  - Clearwater, Florida, United States, 33756
    - Research Site
  - Clearwater, Florida, United States
    - Research Site
  - Coral Gables, Florida, United States, 33134
    - Research Site
  - Coral Gables, Florida, United States
    - Research Site
  - Fort Lauderdale, Florida, United States
    - Research Site
  - Fort Lauderdale, Florida, United States, 33334
    - Research Site
  - Hialeah, Florida, United States
    - Research Site
  - Hialeah, Florida, United States, 33013
    - Research Site
  - Kissimmee, Florida, United States, 34741
    - Research Site
  - Kissimmee, Florida, United States
    - Research Site
  - Miami, Florida, United States
    - Research Site
  - Miami, Florida, United States, 33186
    - Research Site
  - Orlando, Florida, United States
    - Research Site
  - Orlando, Florida, United States, 32825
    - Research Site
  - Ormond Beach, Florida, United States, 32174
    - Research Site
  - Ormond Beach, Florida, United States
    - Research Site
  - Panama City, Florida, United States, 32405
    - Research Site
  - Panama City, Florida, United States
    - Research Site
  - Pensacola, Florida, United States
    - Research Site
  - Pensacola, Florida, United States, 32503
    - Research Site
  - Port Orange, Florida, United States, 32129
    - Research Site
  - Port Orange, Florida, United States
    - Research Site
  - Saint Petersburg, Florida, United States, 33710
    - Research Site
  - Saint Petersburg, Florida, United States
    - Research Site
  - Sarasota, Florida, United States, 34239
    - Research Site
  - Sarasota, Florida, United States
    - Research Site
  - Sebring, Florida, United States
    - Research Site
  - Sebring, Florida, United States, 33870
    - Research Site
  - Winter Park, Florida, United States
    - Research Site
  - Winter Park, Florida, United States, 32789-4681
    - Research Site
- Georgia
  - Atlanta, Georgia, United States
    - Research Site
  - Atlanta, Georgia, United States, 30342
    - Research Site
  - Atlanta, Georgia, United States, 30331
    - Research Site
  - Lawrenceville, Georgia, United States
    - Research Site
  - Lawrenceville, Georgia, United States, 30046
    - Research Site
  - Rincon, Georgia, United States, 31326
    - Research Site
  - Rincon, Georgia, United States
    - Research Site
  - Stockbridge, Georgia, United States
    - Research Site
  - Stockbridge, Georgia, United States, 30281
    - Research Site
- Idaho
  - Eagle, Idaho, United States, 83616
    - Research Site
  - Eagle, Idaho, United States
    - Research Site
  - Nampa, Idaho, United States
    - Research Site
  - Nampa, Idaho, United States, 83687
    - Research Site
- Illinois
  - Chicago, Illinois, United States
    - Research Site
  - Chicago, Illinois, United States, 60607
    - Research Site
  - Springfield, Illinois, United States
    - Research Site
  - Springfield, Illinois, United States, 62704
    - Research Site
- Indiana
  - Avon, Indiana, United States, 46123
    - Research Site
  - Avon, Indiana, United States
    - Research Site
  - Brownsburg, Indiana, United States, 46112
    - Research Site
  - Brownsburg, Indiana, United States
    - Research Site
  - Muncie, Indiana, United States
    - Research Site
  - Muncie, Indiana, United States, 47304
    - Research Site
  - Valparaiso, Indiana, United States, 46383
    - Research Site
  - Valparaiso, Indiana, United States
    - Research Site
- Iowa
  - Council Bluffs, Iowa, United States, 51503
    - Research Site
  - Council Bluffs, Iowa, United States
    - Research Site
- Kentucky
  - Fort Mitchell, Kentucky, United States
    - Research Site
  - Fort Mitchell, Kentucky, United States, 41017
    - Research Site
  - Hazard, Kentucky, United States
    - Research Site
  - Hazard, Kentucky, United States, 41701
    - Research Site
- Louisiana
  - Opelousas, Louisiana, United States
    - Research Site
  - Opelousas, Louisiana, United States, 70570
    - Research Site
  - Shreveport, Louisiana, United States
    - Research Site
  - Shreveport, Louisiana, United States, 71104
    - Research Site
  - Sunset, Louisiana, United States
    - Research Site
  - Sunset, Louisiana, United States, 70584
    - Research Site
- Maine
  - Bangor, Maine, United States
    - Research Site
  - Bangor, Maine, United States, 04401
    - Research Site
- Massachusetts
  - Brockton, Massachusetts, United States, 02301
    - Research Site
  - Brockton, Massachusetts, United States
    - Research Site
- Michigan
  - Farmington Hills, Michigan, United States
    - Research Site
  - Farmington Hills, Michigan, United States, 48336
    - Research Site
  - Port Huron, Michigan, United States, 48060
    - Research Site
  - Port Huron, Michigan, United States
    - Research Site
- Minnesota
  - Minneapolis, Minnesota, United States, 55402
    - Research Site
  - Minneapolis, Minnesota, United States
    - Research Site
  - Plymouth, Minnesota, United States, 55441
    - Research Site
  - Plymouth, Minnesota, United States
    - Research Site
- Mississippi
  - Biloxi, Mississippi, United States, 39531
    - Research Site
  - Biloxi, Mississippi, United States
    - Research Site
- Missouri
  - Saint Louis, Missouri, United States, 63141
    - Research Site
  - Saint Louis, Missouri, United States
    - Research Site
- Montana
  - Billings, Montana, United States
    - Research Site
  - Billings, Montana, United States, 59102
    - Research Site
- Nebraska
  - Bellevue, Nebraska, United States
    - Research Site
  - Bellevue, Nebraska, United States, 68005
    - Research Site
  - Lincoln, Nebraska, United States, 68510
    - Research Site
  - Lincoln, Nebraska, United States
    - Research Site
  - Omaha, Nebraska, United States
    - Research Site
  - Omaha, Nebraska, United States, 68114
    - Research Site
- New Jersey
  - Marlton, New Jersey, United States, 08053
    - Research Site
  - Marlton, New Jersey, United States
    - Research Site
  - Summit, New Jersey, United States, 07901
    - Research Site
  - Summit, New Jersey, United States
    - Research Site
- New York
  - Jackson Heights, New York, United States, 11372
    - Research Site
  - Jackson Heights, New York, United States
    - Research Site
  - Rochester, New York, United States, 14618
    - Research Site
  - Rochester, New York, United States
    - Research Site
- North Carolina
  - Charlotte, North Carolina, United States
    - Research Site
  - Charlotte, North Carolina, United States, 28204
    - Research Site
  - Cornelius, North Carolina, United States, 28031
    - Research Site
  - Cornelius, North Carolina, United States
    - Research Site
  - Flat Rock, North Carolina, United States
    - Research Site
  - Flat Rock, North Carolina, United States, 28731
    - Research Site
  - Greensboro, North Carolina, United States, 27408
    - Research Site
  - Greensboro, North Carolina, United States
    - Research Site
  - High Point, North Carolina, United States, 27262
    - Research Site
  - High Point, North Carolina, United States
    - Research Site
- Ohio
  - Cadiz, Ohio, United States, 43907
    - Research Site
  - Cadiz, Ohio, United States
    - Research Site
  - Cincinnati, Ohio, United States, 45231
    - Research Site
  - Cincinnati, Ohio, United States, 45242
    - Research Site
  - Cincinnati, Ohio, United States
    - Research Site
  - Columbus, Ohio, United States
    - Research Site
  - Columbus, Ohio, United States, 43214
    - Research Site
  - Genoa, Ohio, United States, 43430
    - Research Site
  - Genoa, Ohio, United States
    - Research Site
  - Marion, Ohio, United States, 43302
    - Research Site
  - Marion, Ohio, United States
    - Research Site
  - Maumee, Ohio, United States, 43537
    - Research Site
  - Maumee, Ohio, United States
    - Research Site
  - Willoughby, Ohio, United States, 44094
    - Research Site
  - Willoughby, Ohio, United States
    - Research Site
- Oklahoma
  - Oklahoma City, Oklahoma, United States
    - Research Site
  - Oklahoma City, Oklahoma, United States, 73103
    - Research Site
- Oregon
  - Medford, Oregon, United States, 97504
    - Research Site
  - Medford, Oregon, United States
    - Research Site
  - Portland, Oregon, United States, 97202
    - Research Site
  - Portland, Oregon, United States
    - Research Site
- Pennsylvania
  - Jefferson Hills, Pennsylvania, United States, 15025
    - Research Site
  - Jefferson Hills, Pennsylvania, United States
    - Research Site
  - Scottdale, Pennsylvania, United States, 15683
    - Research Site
  - Scottdale, Pennsylvania, United States
    - Research Site
  - Uniontown, Pennsylvania, United States, 15401
    - Research Site
  - Uniontown, Pennsylvania, United States
    - Research Site
- South Carolina
  - Anderson, South Carolina, United States, 29621
    - Research Site
  - Anderson, South Carolina, United States
    - Research Site
  - Easley, South Carolina, United States
    - Research Site
  - Easley, South Carolina, United States, 29640
    - Research Site
  - Greenville, South Carolina, United States, 29615
    - Research Site
  - Greenville, South Carolina, United States
    - Research Site
  - Indian Land, South Carolina, United States, 29707
    - Research Site
  - Indian Land, South Carolina, United States
    - Research Site
  - Myrtle Beach, South Carolina, United States
    - Research Site
  - Myrtle Beach, South Carolina, United States, 29588
    - Research Site
  - Spartanburg, South Carolina, United States
    - Research Site
  - Spartanburg, South Carolina, United States, 29303
    - Research Site
- Texas
  - Boerne, Texas, United States, 78006
    - Research Site
  - Boerne, Texas, United States
    - Research Site
  - Dallas, Texas, United States, 75225
    - Research Site
  - Dallas, Texas, United States
    - Research Site
  - El Paso, Texas, United States
    - Research Site
  - El Paso, Texas, United States, 79903
    - Research Site
  - Houston, Texas, United States
    - Research Site
  - Houston, Texas, United States, 77034
    - Research Site
  - McKinney, Texas, United States, 75069
    - Research Site
  - McKinney, Texas, United States
    - Research Site
  - Plano, Texas, United States
    - Research Site
  - Plano, Texas, United States, 75093
    - Research Site
  - Sealy, Texas, United States
    - Research Site
  - Sealy, Texas, United States, 77474
    - Research Site
- Utah
  - Midvale, Utah, United States, 84047
    - Research Site
  - Midvale, Utah, United States
    - Research Site
  - Salt Lake City, Utah, United States
    - Research Site
  - Salt Lake City, Utah, United States, 84124
    - Research Site
- Virginia
  - Herndon, Virginia, United States, 20171
    - Research Site
  - Herndon, Virginia, United States
    - Research Site
  - Newport News, Virginia, United States, 23606
    - Research Site
  - Newport News, Virginia, United States
    - Research Site
  - Richmond, Virginia, United States, 23225
    - Research Site
  - Richmond, Virginia, United States
    - Research Site
- Washington
  - Tacoma, Washington, United States, 98405
    - Research Site
  - Tacoma, Washington, United States
    - Research Site
- West Virginia
  - Kingwood, West Virginia, United States, 26357
    - Research Site
  - Kingwood, West Virginia, United States
    - Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

36 years to 91 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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.
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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Symbicort pMDI Symbicort pMDI, budesonide/formoterol, 160/4.5 μg x 2 actuations BID, for oral inhalation	Drug: Symbicort Budesonide/formoterol pMDI, 160/4.5 μg x 2 actuations BID, for oral inhalation, 120 doses Other: Placebo for Symbicort pMDI pMDI, aerosol for oral inhalation, placebo, 120 doses
Active Comparator: Formoterol Turbuhaler Formoterol Turbuhaler, 4.5 μg x 2 actuations BID, for oral inhalation	Drug: Formoterol turbohaler Formoterol Turbuhaler 4.5 μg x 2 actuations BID, for oral inhalation, 60 doses Other: Placebo for Formoterol Turbohaler PLacebo powder for oral inhalation, 60 doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Randomization at Week 0 to End of Treatment (EoT) W 26

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients With Moderate or Severe COPD Exacerbation. Time Frame: From randomzation to EoT W 26	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.	From randomzation to EoT W 26
St. George's Respiratory Questionnaire (SGRQ) Time Frame: From Run-in W -4 to EoT W 26	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.	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	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.	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	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.	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	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.	From Run-in W -4 to EoT W 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

Principal Investigator: Gary T Ferguson, MD, Pulmonary Research Insititute of Southeast Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Symbicort RISE Revised CSP 3 4 FINAL Redacted

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 27, 2014

Primary Completion (Actual)

February 8, 2016

Study Completion (Actual)

February 8, 2016

Study Registration Dates

First Submitted

June 5, 2014

First Submitted That Met QC Criteria

June 5, 2014

First Posted (Estimate)

June 6, 2014

Study Record Updates

Last Update Posted (Actual)

November 7, 2017

Last Update Submitted That Met QC Criteria

October 5, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

COPD, turbuhaler, pMDI

Additional Relevant MeSH Terms

Other Study ID Numbers

D589UC00001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Publications and helpful links

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on COPD Patients

Clinical Trials on Symbicort

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