A 6 Month Safety Study Comparing Symbicort With Inhaled Corticosteroid Only in Asthmatic Adults and Adolescents
A 26 Week, Randomized, Double-blind, Parallel-group, Active Controlled, Multicenter, Multinational Safety Study Evaluating the Risk of Serious Asthma-related Events During Treatment With Symbicort®, a Fixed Combination of Inhaled Corticosteroid (ICS) (Budesonide) and a Long Acting β2-agonist (LABA) (Formoterol) as Compared to Treatment With ICS (Budesonide) Alone in Adult and Adolescent (≥12 Years of Age) Patients With Asthma
2 other identifiers
interventional
12,460
26 countries
340
Brief Summary
The purpose of the study is to evaluate the safety of Symbicort compared to inhaled corticosteroid alone during 6 months in adult and adolescent patients with asthma
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 asthma
Started Dec 2011
Longer than P75 for phase_3 asthma
340 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 23, 2011
CompletedFirst Posted
Study publicly available on registry
September 30, 2011
CompletedStudy Start
First participant enrolled
December 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedResults Posted
Study results publicly available
December 15, 2016
CompletedDecember 15, 2016
November 1, 2016
3.8 years
September 23, 2011
April 8, 2016
November 29, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants Experiencing an Event in the Composite Endpoint (Asthma-related Death, Asthma-related Intubation or Asthma-related Hospitalization)
Number of participants experiencing an event in the composite endpoint (asthma-related death, asthma-related intubation or asthma-related hospitalization), using events adjudicated and confirmed by the Joint Adjudication Committee. Cox proportional hazards model with terms for randomized treatment and strata for incoming control/asthma treatment was used to compare Symbicort and budesonide. Hazard ratios and 95% confidence intervals were estimated.
Up to 27 weeks
Number of Participants Experiencing an Event Included in the Definition of Asthma Exacerbation
Number of participants experiencing an event included in the definition of asthma exacerbation. An asthma exacerbation was defined as a deterioration of asthma requiring systemic corticosteroids for at least 3 days or an inpatient hospitalization or emergency room visit due to asthma that required systemic corticosteroids. Cox proportional hazards model with terms for randomized treatment and strata for incoming control/asthma treatment was used to compare Symbicort and budesonide. Hazard ratios and 95% confidence intervals were estimated.
Up to 26 weeks
Secondary Outcomes (6)
Percent of Days With no Asthma Symptoms
Daily up to 26 weeks
Percent of Days With Activity Limitation Due to Asthma
Daily up to 26 weeks
Mean Number of Puffs of Rescue Medication Per 24 Hours
Daily up to 26 weeks
Asthma Control Questionnaire (ACQ6)
baseline, day 28, day 84, day 182
Percent of Nights With Awakening(s) Due to Asthma
Daily up to 26 weeks
- +1 more secondary outcomes
Study Arms (2)
1
EXPERIMENTALSymbicort
2
ACTIVE COMPARATORbudesonide
Interventions
Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening), for oral inhalation.
Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening), for oral inhalation.
Eligibility Criteria
You may qualify if:
- Provision of signed informed consent/ paediatric assent (if applicable) prior to any study specific procedures including medication withdrawal
- Male or Female, ≥12 years of age
- Documented clinical diagnosis of asthma for at least 1 year prior to Visit 2
- Patient must have history of at least 1 asthma exacerbation including one of the following:
- requiring treatment with systemic corticosteroids
- an asthma-related hospitalization between 4 weeks and 12 months prior to randomization
- Current Asthma Therapy: Patients must be appropriately using one of the treatments for asthma listed in the protocol combined with achieving certain results when recording an Asthma Control Questionnaire
You may not qualify if:
- Patient has a history of life-threatening asthma. Defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea requiring non-invasive ventilatory support.
- Patient has required treatment with systemic corticosteroids (tablets, suspensions or injectable) for any reason within 4 weeks prior to Visit 2
- Patient has an ongoing exacerbation, defined as a worsening of asthma that requires treatment with systemic corticosteroids (tablets, suspension, or injectable)
- An asthma exacerbation within 4 weeks of randomization or more than 4 separate exacerbations in the 12 months preceding randomization or more than 2 hospitalizations for treatment of asthma in the 12 months preceding randomization
- Patient has a respiratory infection or other viral/bacterial illness, or is recovering from such an illness at the time of Visit 2 that, in the investigator's opinion, will interfere with the patient's lung function
- Patient must not meet unstable asthma severity criteria as listed in the protocol
- Peak expiratory flow must not be below 50% o predicted normal
- Pregnancy, breast-feeding or planned pregnancy during the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (340)
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Birmingham, Alabama, United States
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Huntsville, Alabama, United States
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Anchorage, Alaska, United States
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Gilbert, Arizona, United States
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Glendale, Arizona, United States
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Mesa, Arizona, United States
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Tucson, Arizona, United States
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Fort Smith, Arkansas, United States
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Little Rock, Arkansas, United States
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Alhambra, California, United States
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Anaheim, California, United States
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Arvin, California, United States
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Bellflower, California, United States
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Buena Park, California, United States
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Costa Mesa, California, United States
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Encinitas, California, United States
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Escondido, California, United States
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Fountain Valley, California, United States
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Glendale, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Newport Beach, California, United States
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Northridge, California, United States
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Palmdale, California, United States
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Pasadena, California, United States
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Poway, California, United States
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Riverside, California, United States
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Roseville, California, United States
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San Diego, California, United States
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San Jose, California, United States
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Santa Ana, California, United States
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Stockton, California, United States
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Tustin, California, United States
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Walnut Creek, California, United States
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Denver, Colorado, United States
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Thornton, Colorado, United States
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Norwalk, Connecticut, United States
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Waterbury, Connecticut, United States
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Altamonte Springs, Florida, United States
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Clearwater, Florida, United States
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DeLand, Florida, United States
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Fort Lauderdale, Florida, United States
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Fort Myers, Florida, United States
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Gainesville, Florida, United States
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Hialeah, Florida, United States
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Jacksonville, Florida, United States
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Kissimmee, Florida, United States
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Leesburg, Florida, United States
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Lehigh Acres, Florida, United States
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Lynn Haven, Florida, United States
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Miami, Florida, United States
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Miami Beach, Florida, United States
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Ocoee, Florida, United States
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Opa-locka, Florida, United States
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Orlando, Florida, United States
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Pembroke Pines, Florida, United States
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Royal Palm Beach, Florida, United States
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Tampa, Florida, United States
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Calhoun, Georgia, United States
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Conyers, Georgia, United States
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Decatur, Georgia, United States
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Gainesville, Georgia, United States
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Savannah, Georgia, United States
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Hayden Lake, Idaho, United States
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Meridan, Idaho, United States
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Kenilworth, Illinois, United States
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Springfield, Illinois, United States
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Anderson, Indiana, United States
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Evansville, Indiana, United States
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Michigan City, Indiana, United States
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Ames, Iowa, United States
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Council Bluffs, Iowa, United States
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Fort Mitchell, Kentucky, United States
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Lexington, Kentucky, United States
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Owensboro, Kentucky, United States
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Lafayette, Louisiana, United States
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Lake Charles, Louisiana, United States
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Shreveport, Louisiana, United States
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Baltimore, Maryland, United States
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Lanham, Maryland, United States
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Watertown, Massachusetts, United States
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Kalamazoo, Michigan, United States
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Madison Hgts, Michigan, United States
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Port Huron, Michigan, United States
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Southfield, Michigan, United States
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Sterling Heights, Michigan, United States
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Ypsilanti, Michigan, United States
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Duluth, Minnesota, United States
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Edina, Minnesota, United States
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Biloxi, Mississippi, United States
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Jackson, Mississippi, United States
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Vicksburg, Mississippi, United States
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Bridgeton, Missouri, United States
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Chesterfield, Missouri, United States
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Kansas City, Missouri, United States
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Springfield, Missouri, United States
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St Louis, Missouri, United States
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Bellevue, Nebraska, United States
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Grand Island, Nebraska, United States
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Omaha, Nebraska, United States
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Verona, New Jersey, United States
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Great Neck, New York, United States
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Hopewell Jct, New York, United States
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New York, New York, United States
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Rochester, New York, United States
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Rockville Centre, New York, United States
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The Bronx, New York, United States
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Watertown, New York, United States
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Cary, North Carolina, United States
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Charlotte, North Carolina, United States
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Greensboro, North Carolina, United States
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Salisbury, North Carolina, United States
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Wilmington, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Fargo, North Dakota, United States
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Cincinnati, Ohio, United States
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Miamishburg, Ohio, United States
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Stow, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Bend, Oregon, United States
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Abington, Pennsylvania, United States
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Bryn Mawr, Pennsylvania, United States
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Doylestown, Pennsylvania, United States
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Phoenixville, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Wyomissing, Pennsylvania, United States
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Warwick, Rhode Island, United States
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Charleston, South Carolina, United States
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Greeneville, South Carolina, United States
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Greenville, South Carolina, United States
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Greer, South Carolina, United States
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Old Point Station, South Carolina, United States
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Summerville, South Carolina, United States
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Knoxville, Tennessee, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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Baytown, Texas, United States
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Dallas, Texas, United States
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Fort Worth, Texas, United States
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Georgetown, Texas, United States
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Houston, Texas, United States
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Killeen, Texas, United States
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McKinney, Texas, United States
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Pharr, Texas, United States
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Plano, Texas, United States
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San Antonio, Texas, United States
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Spring, Texas, United States
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Sugar Land, Texas, United States
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Sugarland, Texas, United States
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Waco, Texas, United States
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Layton, Utah, United States
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South Burlington, Vermont, United States
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Danville, Virginia, United States
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Vienna, Virginia, United States
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Virginia Beach, Virginia, United States
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Seattle, Washington, United States
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Spokane, Washington, United States
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Tacoma, Washington, United States
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La Crosse, Wisconsin, United States
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Milwaukee, Wisconsin, United States
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Buenos Aires, Argentina
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Ciudad de Buenos Aires, Argentina
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Córdoba, Argentina
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Mar del Plata, Argentina
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Monte Grande, Argentina
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Quilmes, Argentina
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Ranelagh, Argentina
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San Miguel de Tucumán, Argentina
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Barueri, Brazil
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Botucatu, Brazil
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Goiânia, Brazil
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Juiz de Fora, Brazil
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Porto Alegre, Brazil
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Santo André, Brazil
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São Paulo, Brazil
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Gotse Delchev, Bulgaria
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Kozloduy, Bulgaria
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Petrich, Bulgaria
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Pleven, Bulgaria
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Razgrad, Bulgaria
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Razlog, Bulgaria
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Rousse, Bulgaria
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Sandanski, Bulgaria
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Sevlievo, Bulgaria
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Sofia, Bulgaria
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Stara Zagora, Bulgaria
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Varna, Bulgaria
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Vidin, Bulgaria
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Quillota, Chile
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Santiago, Chile
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Viña del Mar, Chile
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Bogotá, Colombia
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Cali, Colombia
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Manizales, Colombia
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Beroun, Czechia
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Břeclav, Czechia
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Krnov, Czechia
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Kutná Hora, Czechia
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Litoměřice, Czechia
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Ostrava, Czechia
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Pilsen, Czechia
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Prague, Czechia
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Rokycany, Czechia
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Angers, France
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Perpignan, France
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Tiercé, France
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Berlin, Germany
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Hamburg, Germany
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Leipzig, Germany
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Marburg, Germany
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Bangalore, India
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Calicut, India
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Coimbatore, India
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Goa, India
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Hyderabad, India
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Mangalore, India
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Mysore, India
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Nagpur, India
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New Delhi, India
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Trivandrum, India
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Benevento, Italy
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Bologna, Italy
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Catanzaro, Italy
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Ferrara, Italy
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Genova, Italy
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Napoli, Italy
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Padua, Italy
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Palermo, Italy
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Roma, Italy
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Durango, Mexico
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Guadalajara, Mexico
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México, Mexico
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Monterrey, Mexico
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Morelia, Mexico
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Querétaro City, Mexico
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Villahermosa, Mexico
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Zapopan, Mexico
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Panama City, Panama
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Cusco, Peru
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Lima, Peru
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Iloilo City, Philippines
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Lipa City, Philippines
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Manila, Philippines
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Pasig, Philippines
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Quezon City, Philippines
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Bialystok, Poland
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Bydgoszcz, Poland
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Chęciny, Poland
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Gorzów Wlkp, Poland
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Karpacz, Poland
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Krakow, Poland
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Ostrów Wielkopolski, Poland
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Skarżysko-Kamienna, Poland
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Strzelce Opolskie, Poland
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Szczecin, Poland
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Tarnów, Poland
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Turek, Poland
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Urszulin, Poland
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Wroclaw, Poland
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Caguas, Puerto Rico
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San Juan, Puerto Rico
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Toa Baja, Puerto Rico
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Bragadiru, Romania
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Brasov, Romania
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Bucharest, Romania
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Cluj-Napoca, Romania
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Constanța, Romania
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Craiova, Romania
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Deva, Romania
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Iași, Romania
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Tg. Mures, Romania
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Kazan', Russia
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Moscow, Russia
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Novosibirsk, Russia
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Penza, Russia
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Saint Petersburg, Russia
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Saratov, Russia
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StPetersburg, Russia
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Vladikavkaz, Russia
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Volgograd, Russia
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Yaroslavl, Russia
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Yekaterinburg, Russia
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Bardejov, Slovakia
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Bratislava, Slovakia
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Dunajská Streda, Slovakia
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Komárno, Slovakia
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Košice, Slovakia
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Liptovský Mikuláš, Slovakia
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Nitra, Slovakia
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Prešov, Slovakia
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Ružomberok, Slovakia
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Skalica, Slovakia
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Zvolen, Slovakia
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Žilina, Slovakia
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Boksburg North, South Africa
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Breyten, South Africa
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Cape Town, South Africa
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Durban, South Africa
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eMkhomazi, South Africa
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Johannesburg, South Africa
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Lenasia, South Africa
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Lyttleton, South Africa
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Pretoria, South Africa
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Verulam, South Africa
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Ansan-si, South Korea
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Cheonan-si, South Korea
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Cheongju-si, South Korea
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Jinju, South Korea
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Seongnam-si, South Korea
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Seoul, South Korea
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Bangkok, Thailand
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Hat Yai, Thailand
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Khon Kaen, Thailand
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Muang,, Thailand
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Naimuang, Thailand
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Dnipropetrovsk, Ukraine
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Donetsk, Ukraine
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Ivano-Frankivsk, Ukraine
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Kharkiv, Ukraine
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Kiev, Ukraine
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Odesa, Ukraine
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Poltava, Ukraine
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Uzhhorod, Ukraine
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Vinnitsa, Ukraine
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Zaporozye, Ukraine
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Bath, United Kingdom
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Belfast, United Kingdom
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Blackpool, United Kingdom
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Canterbury, United Kingdom
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Chippenham, United Kingdom
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Coventry, United Kingdom
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Crawley, United Kingdom
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Leicester, United Kingdom
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Royal Leamington Spa, United Kingdom
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Stockport, United Kingdom
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Trowbridge, United Kingdom
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Watford, United Kingdom
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Westbury, United Kingdom
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Hanoi, Vietnam
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Ho Chi Minh City, Vietnam
Related Publications (1)
Peters SP, Bleecker ER, Canonica GW, Park YB, Ramirez R, Hollis S, Fjallbrant H, Jorup C, Martin UJ. Serious Asthma Events with Budesonide plus Formoterol vs. Budesonide Alone. N Engl J Med. 2016 Sep 1;375(9):850-60. doi: 10.1056/NEJMoa1511190.
PMID: 27579635DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Carin Jorup, Global Clinical Lead (GCL) SYMBICORT
- Organization
- AstraZeneca Research and Development
Study Officials
- STUDY DIRECTOR
Carin Jorup
AstraZeneca Pepparedsleden 1, 431 83 Mölndal
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 23, 2011
First Posted
September 30, 2011
Study Start
December 1, 2011
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
December 15, 2016
Results First Posted
December 15, 2016
Record last verified: 2016-11