Comparing the Efficacy of Symbicort® pMDI and Formoterol Turbuhaler in Reducing Exacerbations in Patients With Cronic Obstructive Pulmonary Disease
RISE
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.
1 other identifier
interventional
2,026
11 countries
371
Brief Summary
Comparing the efficacy of Symbicort® pMDI and Formoterol Turbuhaler in reducing exacerbations in patients with Chronic Obstructive Pulmonary Disease (COPD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2014
371 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 5, 2014
CompletedFirst Posted
Study publicly available on registry
June 6, 2014
CompletedStudy Start
First participant enrolled
June 27, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 8, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 8, 2016
CompletedResults Posted
Study results publicly available
June 12, 2017
CompletedNovember 7, 2017
October 1, 2017
1.6 years
June 5, 2014
December 15, 2016
October 5, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
Randomization at Week 0 to End of Treatment (EoT) W 26
Secondary Outcomes (5)
Number of Patients With Moderate or Severe COPD Exacerbation.
From randomzation to EoT W 26
St. George's Respiratory Questionnaire (SGRQ)
From Run-in W -4 to EoT W 26
Pre-dose/Pre-bronchodilator FEV1 at the Study Site
From Run-in W -4 to EoT W 26
Total Rescue Medication Use (Average Puffs/Day)
From Run-in W -4 to EoT W 26
Nights With Awakening Due to COPD
From Run-in W -4 to EoT W 26
Study Arms (2)
Symbicort pMDI
ACTIVE COMPARATORSymbicort pMDI, budesonide/formoterol, 160/4.5 μg x 2 actuations BID, for oral inhalation
Formoterol Turbuhaler
ACTIVE COMPARATORFormoterol Turbuhaler, 4.5 μg x 2 actuations BID, for oral inhalation
Interventions
Budesonide/formoterol pMDI, 160/4.5 μg x 2 actuations BID, for oral inhalation, 120 doses
Formoterol Turbuhaler 4.5 μg x 2 actuations BID, for oral inhalation, 60 doses
PLacebo powder for oral inhalation, 60 doses
Eligibility Criteria
You may qualify if:
- \. A current clinical diagnosis of COPD with COPD symptoms for more than 1 year, according to the GOLD guidelines.
- \. 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).
- \. Post-bronchodilator FEV1/forced vital capacity (FVC) \<0.7 (70%) and FEV1 ≤70% of predicted normal (PN) value.
- \. Documented use of a short-acting inhaled bronchodilator (β2-agonists or anticholinergics) as rescue medication within 6 months prior to study start.
- \. 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (371)
Research Site
Andalusia, Alabama, 36420, United States
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Andalusia, Alabama, United States
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Birmingham, Alabama, 35209, United States
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Birmingham, Alabama, United States
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Foley, Alabama, 36535, United States
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Foley, Alabama, United States
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Jasper, Alabama, 35501, United States
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Jasper, Alabama, United States
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Mobile, Alabama, 36608, United States
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Mobile, Alabama, United States
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Chandler, Arizona, 85224, United States
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Chandler, Arizona, United States
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Flagstaff, Arizona, 86001, United States
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Flagstaff, Arizona, United States
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Peoria, Arizona, 85381, United States
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Peoria, Arizona, United States
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Phoenix, Arizona, 85018, United States
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Phoenix, Arizona, 85050, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, 85724, United States
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Tucson, Arizona, United States
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Little Rock, Arkansas, 72204, United States
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Little Rock, Arkansas, United States
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Fresno, California, 93702, United States
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Fresno, California, United States
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Fullerton, California, 92835, United States
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Fullerton, California, United States
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Gold River, California, 95670, United States
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Gold River, California, United States
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Lakewood, California, 90712, United States
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Lakewood, California, United States
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Los Angeles, California, 90025, United States
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Los Angeles, California, 90048, United States
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Los Angeles, California, United States
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Newport Beach, California, 92663, United States
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Newport Beach, California, United States
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Orange, California, 92868, United States
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Orange, California, United States
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Rancho Mirage, California, 92270, United States
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Rancho Mirage, California, United States
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San Jose, California, 95117, United States
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San Jose, California, United States
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Westminster, California, 92683, United States
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Westminster, California, United States
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Aurora, Colorado, 80014, United States
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Aurora, Colorado, United States
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Colorado Springs, Colorado, 80909, United States
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Colorado Springs, Colorado, United States
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Clearwater, Florida, 33756, United States
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Clearwater, Florida, United States
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Coral Gables, Florida, 33134, United States
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Coral Gables, Florida, United States
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Fort Lauderdale, Florida, 33334, United States
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Fort Lauderdale, Florida, United States
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Hialeah, Florida, 33013, United States
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Hialeah, Florida, United States
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Kissimmee, Florida, 34741, United States
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Kissimmee, Florida, United States
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Miami, Florida, 33186, United States
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Miami, Florida, United States
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Orlando, Florida, 32825, United States
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Orlando, Florida, United States
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Ormond Beach, Florida, 32174, United States
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Ormond Beach, Florida, United States
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Panama City, Florida, 32405, United States
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Panama City, Florida, United States
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Pensacola, Florida, 32503, United States
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Pensacola, Florida, United States
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Port Orange, Florida, 32129, United States
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Port Orange, Florida, United States
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Sarasota, Florida, 34239, United States
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Sarasota, Florida, United States
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Sebring, Florida, 33870, United States
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Sebring, Florida, United States
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St. Petersburg, Florida, 33710, United States
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St. Petersburg, Florida, United States
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Winter Park, Florida, 32789-4681, United States
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Winter Park, Florida, United States
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Atlanta, Georgia, 30331, United States
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Atlanta, Georgia, 30342, United States
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Atlanta, Georgia, United States
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Lawrenceville, Georgia, 30046, United States
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Lawrenceville, Georgia, United States
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Rincon, Georgia, 31326, United States
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Rincon, Georgia, United States
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Stockbridge, Georgia, 30281, United States
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Stockbridge, Georgia, United States
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Eagle, Idaho, 83616, United States
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Eagle, Idaho, United States
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Nampa, Idaho, 83687, United States
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Nampa, Idaho, United States
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Chicago, Illinois, 60607, United States
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Chicago, Illinois, United States
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Springfield, Illinois, 62704, United States
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Springfield, Illinois, United States
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Avon, Indiana, 46123, United States
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Avon, Indiana, United States
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Brownsburg, Indiana, 46112, United States
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Brownsburg, Indiana, United States
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Muncie, Indiana, 47304, United States
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Muncie, Indiana, United States
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Valparaiso, Indiana, 46383, United States
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Valparaiso, Indiana, United States
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Council Bluffs, Iowa, 51503, United States
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Council Bluffs, Iowa, United States
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Fort Mitchell, Kentucky, 41017, United States
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Fort Mitchell, Kentucky, United States
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Hazard, Kentucky, 41701, United States
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Hazard, Kentucky, United States
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Opelousas, Louisiana, 70570, United States
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Opelousas, Louisiana, United States
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Shreveport, Louisiana, 71104, United States
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Shreveport, Louisiana, United States
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Sunset, Louisiana, 70584, United States
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Sunset, Louisiana, United States
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Bangor, Maine, 04401, United States
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Bangor, Maine, United States
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Brockton, Massachusetts, 02301, United States
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Brockton, Massachusetts, United States
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Farmington Hills, Michigan, 48336, United States
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Farmington Hills, Michigan, United States
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Port Huron, Michigan, 48060, United States
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Port Huron, Michigan, United States
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Minneapolis, Minnesota, 55402, United States
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Minneapolis, Minnesota, United States
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Plymouth, Minnesota, 55441, United States
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Plymouth, Minnesota, United States
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Biloxi, Mississippi, 39531, United States
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Biloxi, Mississippi, United States
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St Louis, Missouri, 63141, United States
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St Louis, Missouri, United States
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Billings, Montana, 59102, United States
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Billings, Montana, United States
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Bellevue, Nebraska, 68005, United States
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Bellevue, Nebraska, United States
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Lincoln, Nebraska, 68510, United States
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Lincoln, Nebraska, United States
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Omaha, Nebraska, 68114, United States
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Omaha, Nebraska, United States
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Marlton, New Jersey, 08053, United States
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Marlton, New Jersey, United States
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Summit, New Jersey, 07901, United States
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Summit, New Jersey, United States
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Jackson Heights, New York, 11372, United States
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Jackson Heights, New York, United States
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Rochester, New York, 14618, United States
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Rochester, New York, United States
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Charlotte, North Carolina, 28204, United States
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Charlotte, North Carolina, United States
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Cornelius, North Carolina, 28031, United States
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Cornelius, North Carolina, United States
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Flat Rock, North Carolina, 28731, United States
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Flat Rock, North Carolina, United States
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Greensboro, North Carolina, 27408, United States
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Greensboro, North Carolina, United States
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High Point, North Carolina, 27262, United States
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High Point, North Carolina, United States
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Cadiz, Ohio, 43907, United States
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Cadiz, Ohio, United States
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Cincinnati, Ohio, 45231, United States
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Cincinnati, Ohio, 45242, United States
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Cincinnati, Ohio, United States
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Columbus, Ohio, 43214, United States
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Columbus, Ohio, United States
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Genoa, Ohio, 43430, United States
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Genoa, Ohio, United States
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Marion, Ohio, 43302, United States
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Marion, Ohio, United States
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Maumee, Ohio, 43537, United States
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Maumee, Ohio, United States
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Willoughby, Ohio, 44094, United States
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Willoughby, Ohio, United States
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Oklahoma City, Oklahoma, 73103, United States
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Oklahoma City, Oklahoma, United States
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Medford, Oregon, 97504, United States
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Medford, Oregon, United States
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Portland, Oregon, 97202, United States
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Portland, Oregon, United States
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Jefferson Hills, Pennsylvania, 15025, United States
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Jefferson Hills, Pennsylvania, United States
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Scottdale, Pennsylvania, 15683, United States
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Scottdale, Pennsylvania, United States
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Uniontown, Pennsylvania, 15401, United States
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Uniontown, Pennsylvania, United States
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Anderson, South Carolina, 29621, United States
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Anderson, South Carolina, United States
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Easley, South Carolina, 29640, United States
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Easley, South Carolina, United States
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Greenville, South Carolina, 29615, United States
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Greenville, South Carolina, United States
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Myrtle Beach, South Carolina, 29588, United States
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Myrtle Beach, South Carolina, United States
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Old Point Station, South Carolina, 29707, United States
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Old Point Station, South Carolina, United States
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Spartanburg, South Carolina, 29303, United States
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Spartanburg, South Carolina, United States
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Boerne, Texas, 78006, United States
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Boerne, Texas, United States
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Dallas, Texas, 75225, United States
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Dallas, Texas, United States
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El Paso, Texas, 79903, United States
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El Paso, Texas, United States
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Houston, Texas, 77034, United States
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Houston, Texas, United States
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McKinney, Texas, 75069, United States
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McKinney, Texas, United States
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Plano, Texas, 75093, United States
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Plano, Texas, United States
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Sealy, Texas, 77474, United States
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Sealy, Texas, United States
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Midvale, Utah, 84047, United States
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Midvale, Utah, United States
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Salt Lake City, Utah, 84124, United States
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Salt Lake City, Utah, United States
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Herndon, Virginia, 20171, United States
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Herndon, Virginia, United States
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Newport News, Virginia, 23606, United States
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Newport News, Virginia, United States
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Richmond, Virginia, 23225, United States
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Richmond, Virginia, United States
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Tacoma, Washington, 98405, United States
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Tacoma, Washington, United States
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Kingwood, West Virginia, 26357, United States
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Kingwood, West Virginia, United States
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CABA, 1426, Argentina
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CABA, C1425BEN, Argentina
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CABA, Argentina
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Corrientes, 3400, Argentina
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Corrientes, Argentina
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Córdoba, X5003DCE, Argentina
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Córdoba, Argentina
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Mendoza, 5500, Argentina
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Mendoza, Argentina
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Nueve de Julio, B6500EZL, Argentina
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Nueve de Julio, Argentina
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Ranelagh, 1886, Argentina
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Ranelagh, Argentina
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San Miguel de Tucumán, 4000, Argentina
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San Miguel de Tucumán, Argentina
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Dupnitsa, 2600, Bulgaria
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Dupnitsa, Bulgaria
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Gotse Delchev, 2900, Bulgaria
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Gotse Delchev, Bulgaria
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Kozloduy, 3320, Bulgaria
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Kozloduy, Bulgaria
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Pazardzhik, 4400, Bulgaria
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Pazardzhik, Bulgaria
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Sandanski, 2800, Bulgaria
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Sandanski, Bulgaria
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Sofia, 1404, Bulgaria
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Sofia, 1407, Bulgaria
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Sofia, 1606, Bulgaria
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Sofia, 1618, Bulgaria
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Sofia, Bulgaria
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Stara Zagora, 6000, Bulgaria
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Stara Zagora, 6003, Bulgaria
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Stara Zagora, Bulgaria
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Varna, 9000, Bulgaria
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Varna, 9010, Bulgaria
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Varna, Bulgaria
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Veliko Tarnovo, 5000, Bulgaria
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Veliko Tarnovo, Bulgaria
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Velingrad, 4600, Bulgaria
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Velingrad, Bulgaria
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Santiago, 7500698, Chile
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Santiago, 8380456, Chile
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Santiago, 8910131, Chile
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Santiago, Chile
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Beroun, 266 00, Czechia
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Beroun, Czechia
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Brandýs nad Labem, 250 01, Czechia
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Brandýs nad Labem, Czechia
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Krnov, 794 01, Czechia
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Krnov, Czechia
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Liberec, 460 01, Czechia
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Liberec, Czechia
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Ostrava, 728 80, Czechia
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Ostrava, Czechia
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Ostrava-Poruba, 708 68, Czechia
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Ostrava-Poruba, Czechia
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Prague, 108 00, Czechia
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Prague, 150 00, Czechia
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Prague, 158 00, Czechia
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Prague, 163 00, Czechia
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Prague, Czechia
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Strakonice, 38601, Czechia
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Strakonice, Czechia
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Žatec, 43801, Czechia
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Žatec, Czechia
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Aschaffenburg, 63739, Germany
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Aschaffenburg, Germany
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Bad Lippspringe, 33175, Germany
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Bad Lippspringe, Germany
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Berlin, 10119, Germany
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Berlin, 10787, Germany
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Berlin, 13187, Germany
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Berlin, Germany
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Cologne, 51069, Germany
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Cologne, Germany
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Hanover, 30173, Germany
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Hanover, Germany
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Koblenz, 56068, Germany
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Koblenz, Germany
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Leipzig, 04207, Germany
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Leipzig, 04275, Germany
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Leipzig, Germany
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Magdeburg, 39120, Germany
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Magdeburg, Germany
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Guadalajara, 44200, Mexico
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Guadalajara, 44670, Mexico
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Guadalajara, Mexico
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México, 14050, Mexico
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México, Mexico
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Monterrey, 64460, Mexico
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Monterrey, Mexico
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San Juan del Río, 76800, Mexico
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San Juan del Río, Mexico
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Sonora, 83000, Mexico
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Sonora, Mexico
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Aleksandrów Łódzki, 95-070, Poland
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Aleksandrów Łódzki, Poland
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Bialystok, 15-003, Poland
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Bialystok, 15-430, Poland
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Bialystok, Poland
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Bielsk Podlaski, 17-100, Poland
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Bielsk Podlaski, Poland
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Bydgoszcz, 85-231, Poland
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Bydgoszcz, Poland
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Kościan, 64-000, Poland
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Kościan, Poland
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Krakow, 31-209, Poland
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Krakow, Poland
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Lublin, 20-709, Poland
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Lublin, Poland
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Ostrowiec Świętokrzyski, 27-400, Poland
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Ostrowiec Świętokrzyski, Poland
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Piła, 64-920, Poland
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Piła, Poland
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Poznan, 60-685, Poland
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Poznan, Poland
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Rzeszów, 35-205, Poland
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Rzeszów, Poland
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Skarżysko-Kamienna, 26-110, Poland
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Skarżysko-Kamienna, Poland
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Turek, 62-700, Poland
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Turek, Poland
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Zabrze, 41-800, Poland
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Zabrze, Poland
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Żnin, 88-400, Poland
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Żnin, Poland
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San Juan, 00927, Puerto Rico
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San Juan, Puerto Rico
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Cape Town, 1730, South Africa
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Cape Town, 7700, South Africa
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Cape Town, 7764, South Africa
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Cape Town, South Africa
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Durban, 4001, South Africa
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Durban, 4301, South Africa
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Durban, South Africa
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eManzimtoti, 4126, South Africa
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eManzimtoti, South Africa
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Gauteng, 2193, South Africa
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Gauteng, South Africa
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Badalona(Barcelona), 08916, Spain
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Badalona(Barcelona), Spain
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Barcelona, 08003, Spain
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Barcelona, Spain
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Loja (Granada), 18300, Spain
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Loja (Granada), Spain
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Zaragoza, 50009, Spain
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Zaragoza, Spain
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Tor Skärby
- Organization
- AstraZeneca
Study Officials
- PRINCIPAL INVESTIGATOR
Gary T Ferguson, MD
Pulmonary Research Insititute of Southeast Michigan
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2014
First Posted
June 6, 2014
Study Start
June 27, 2014
Primary Completion
February 8, 2016
Study Completion
February 8, 2016
Last Updated
November 7, 2017
Results First Posted
June 12, 2017
Record last verified: 2017-10