A 6 Month Safety Study Comparing Symbicort With Inhaled Corticosteroid Only in Asthmatic Adults and Adolescents

NCT ID: NCT01444430

Last Updated: 2016-12-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 12460 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2015-10-31

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

Detailed Description

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.

Conditions

Asthma

Keywords

Symbicort pMDI; Asthma; safety; budesonide

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Symbicort

Group Type: EXPERIMENTAL

Symbicort pMDI

Intervention Type: DRUG

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.

2

budesonide

Group Type: ACTIVE_COMPARATOR

budesonide pMDI

Intervention Type: DRUG

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.

Interventions

Symbicort pMDI

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.

Intervention Type: DRUG

budesonide pMDI

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 130 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carin Jorup

Role: STUDY_DIRECTOR

AstraZeneca Pepparedsleden 1, 431 83 Mölndal

Locations

Research Site

Birmingham, Alabama, United States

Research Site

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

Countries

Sweden; Virgin Islands; United States; Argentina; Brazil; Bulgaria; Chile; Colombia; Czechia; France; Germany; India; Italy; Mexico; Panama; Peru; Philippines; Poland; Puerto Rico; Romania; Russia; Slovakia; South Africa; South Korea; Thailand; Ukraine; United Kingdom; Vietnam

References

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.

Reference Type: DERIVED

PMID: 27579635 (View on PubMed)

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=541&filename=D5896C00027_Protocol_redacted.pdf

D5896C00027\_Protocol\_redacted.pdf

Other Identifiers

2011-002790-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

D5896C00027

Identifier Type: -

Identifier Source: org_study_id