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

Primary Purpose

Asthma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Symbicort pMDI
budesonide pMDI
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Symbicort pMDI, Asthma, safety, budesonide

Eligibility Criteria

12 Years - 130 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Symbicort

budesonide

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Percent of Days With no Asthma Symptoms
Percent of days with no asthma symptoms during the randomized treatment period. Analysis of variance (ANOVA) model including the fixed factors of treatment and strata by incoming control/asthma treatment was used to compare Symbicort and budesonide.
Percent of Days With Activity Limitation Due to Asthma
Percent of days with activity limitation due to asthma during the randomized treatment period. Analysis of variance (ANOVA) model including the fixed factors of treatment and strata by incoming control/asthma treatment was used to compare Symbicort and budesonide.
Mean Number of Puffs of Rescue Medication Per 24 Hours
Mean number of puffs of rescue medication per day (24 hours) during the randomized treatment period. Analysis of variance (ANOVA) model including the fixed factors of treatment and strata by incoming control/asthma treatment was used to compare Symbicort and budesonide.
Asthma Control Questionnaire (ACQ6)
The outcome variable for ACQ6 was the difference between the average of values recorded during the treatment period (day 28, day 84 and day 182) and the baseline measure. Analysis of covariance (ANCOVA) model, including the fixed factors of treatment and strata by incoming control/asthma treatment and baseline ACQ6 as covariate was used to compare Symbicort and budesonide. The asthma control questionnaire, ACQ6, consists of six questions; all assessed on a 7-point scale from 0 to 6, where 0 represents good control and 6 represents poor control. The overall score is the mean of the responses to each of the six questions.
Percent of Nights With Awakening(s) Due to Asthma
Percent of nights with awakening(s) due to asthma during the randomized treatment period. Analysis of variance (ANOVA) model including the fixed factors of treatment and strata by incoming control/asthma treatment was used to compare Symbicort and budesonide.
Number of Participants Experiencing Discontinuation of Investigational Product Due to a Protocol Defined Asthma Exacerbation
Number of participants experiencing discontinuation of investigational product due to a protocol defined 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.

Full Information

First Posted
September 23, 2011
Last Updated
November 29, 2016
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT01444430
Brief Title
A 6 Month Safety Study Comparing Symbicort With Inhaled Corticosteroid Only in Asthmatic Adults and Adolescents
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Symbicort pMDI, Asthma, safety, budesonide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12460 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Symbicort
Arm Title
2
Arm Type
Active Comparator
Arm Description
budesonide
Intervention Type
Drug
Intervention Name(s)
Symbicort pMDI
Intervention Description
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
Intervention Name(s)
budesonide pMDI
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants Experiencing an Event in the Composite Endpoint (Asthma-related Death, Asthma-related Intubation or Asthma-related Hospitalization)
Description
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.
Time Frame
Up to 27 weeks
Title
Number of Participants Experiencing an Event Included in the Definition of Asthma Exacerbation
Description
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.
Time Frame
Up to 26 weeks
Secondary Outcome Measure Information:
Title
Percent of Days With no Asthma Symptoms
Description
Percent of days with no asthma symptoms during the randomized treatment period. Analysis of variance (ANOVA) model including the fixed factors of treatment and strata by incoming control/asthma treatment was used to compare Symbicort and budesonide.
Time Frame
Daily up to 26 weeks
Title
Percent of Days With Activity Limitation Due to Asthma
Description
Percent of days with activity limitation due to asthma during the randomized treatment period. Analysis of variance (ANOVA) model including the fixed factors of treatment and strata by incoming control/asthma treatment was used to compare Symbicort and budesonide.
Time Frame
Daily up to 26 weeks
Title
Mean Number of Puffs of Rescue Medication Per 24 Hours
Description
Mean number of puffs of rescue medication per day (24 hours) during the randomized treatment period. Analysis of variance (ANOVA) model including the fixed factors of treatment and strata by incoming control/asthma treatment was used to compare Symbicort and budesonide.
Time Frame
Daily up to 26 weeks
Title
Asthma Control Questionnaire (ACQ6)
Description
The outcome variable for ACQ6 was the difference between the average of values recorded during the treatment period (day 28, day 84 and day 182) and the baseline measure. Analysis of covariance (ANCOVA) model, including the fixed factors of treatment and strata by incoming control/asthma treatment and baseline ACQ6 as covariate was used to compare Symbicort and budesonide. The asthma control questionnaire, ACQ6, consists of six questions; all assessed on a 7-point scale from 0 to 6, where 0 represents good control and 6 represents poor control. The overall score is the mean of the responses to each of the six questions.
Time Frame
baseline, day 28, day 84, day 182
Title
Percent of Nights With Awakening(s) Due to Asthma
Description
Percent of nights with awakening(s) due to asthma during the randomized treatment period. Analysis of variance (ANOVA) model including the fixed factors of treatment and strata by incoming control/asthma treatment was used to compare Symbicort and budesonide.
Time Frame
Daily up to 26 weeks
Title
Number of Participants Experiencing Discontinuation of Investigational Product Due to a Protocol Defined Asthma Exacerbation
Description
Number of participants experiencing discontinuation of investigational product due to a protocol defined 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.
Time Frame
Up to 26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
130 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carin Jorup
Organizational Affiliation
AstraZeneca Pepparedsleden 1, 431 83 Mölndal
Official's Role
Study Director
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Ames
State/Province
Iowa
Country
United States
Facility Name
Research Site
City
Council Bluffs
State/Province
Iowa
Country
United States
Facility Name
Research Site
City
Fort Mitchell
State/Province
Kentucky
Country
United States
Facility Name
Research Site
City
Lexington
State/Province
Kentucky
Country
United States
Facility Name
Research Site
City
Owensboro
State/Province
Kentucky
Country
United States
Facility Name
Research Site
City
Lafayette
State/Province
Louisiana
Country
United States
Facility Name
Research Site
City
Lake Charles
State/Province
Louisiana
Country
United States
Facility Name
Research Site
City
Shreveport
State/Province
Louisiana
Country
United States
Facility Name
Research Site
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Research Site
City
Lanham
State/Province
Maryland
Country
United States
Facility Name
Research Site
City
Watertown
State/Province
Massachusetts
Country
United States
Facility Name
Research Site
City
Kalamazoo
State/Province
Michigan
Country
United States
Facility Name
Research Site
City
Madison Hgts
State/Province
Michigan
Country
United States
Facility Name
Research Site
City
Port Huron
State/Province
Michigan
Country
United States
Facility Name
Research Site
City
Southfield
State/Province
Michigan
Country
United States
Facility Name
Research Site
City
Sterling Heights
State/Province
Michigan
Country
United States
Facility Name
Research Site
City
Ypsilanti
State/Province
Michigan
Country
United States
Facility Name
Research Site
City
Duluth
State/Province
Minnesota
Country
United States
Facility Name
Research Site
City
Edina
State/Province
Minnesota
Country
United States
Facility Name
Research Site
City
Biloxi
State/Province
Mississippi
Country
United States
Facility Name
Research Site
City
Jackson
State/Province
Mississippi
Country
United States
Facility Name
Research Site
City
Vicksburg
State/Province
Mississippi
Country
United States
Facility Name
Research Site
City
Bridgeton
State/Province
Missouri
Country
United States
Facility Name
Research Site
City
Chesterfield
State/Province
Missouri
Country
United States
Facility Name
Research Site
City
Kansas City
State/Province
Missouri
Country
United States
Facility Name
Research Site
City
Springfield
State/Province
Missouri
Country
United States
Facility Name
Research Site
City
St Louis
State/Province
Missouri
Country
United States
Facility Name
Research Site
City
Bellevue
State/Province
Nebraska
Country
United States
Facility Name
Research Site
City
Grand Island
State/Province
Nebraska
Country
United States
Facility Name
Research Site
City
Omaha
State/Province
Nebraska
Country
United States
Facility Name
Research Site
City
Verona
State/Province
New Jersey
Country
United States
Facility Name
Research Site
City
Bronx
State/Province
New York
Country
United States
Facility Name
Research Site
City
Great Neck
State/Province
New York
Country
United States
Facility Name
Research Site
City
Hopewell Jct
State/Province
New York
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
Country
United States
Facility Name
Research Site
City
Rochester
State/Province
New York
Country
United States
Facility Name
Research Site
City
Rockville Centre
State/Province
New York
Country
United States
Facility Name
Research Site
City
Watertown
State/Province
New York
Country
United States
Facility Name
Research Site
City
Cary
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Charlotte
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Greensboro
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Salisbury
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Wilmington
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Fargo
State/Province
North Dakota
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Miamishburg
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Stow
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Research Site
City
Bend
State/Province
Oregon
Country
United States
Facility Name
Research Site
City
Abington
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Bryn Mawr
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Doylestown
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Phoenixville
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Wyomissing
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Warwick
State/Province
Rhode Island
Country
United States
Facility Name
Research Site
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
Research Site
City
Greeneville
State/Province
South Carolina
Country
United States
Facility Name
Research Site
City
Greenville
State/Province
South Carolina
Country
United States
Facility Name
Research Site
City
Greer
State/Province
South Carolina
Country
United States
Facility Name
Research Site
City
Indian Land
State/Province
South Carolina
Country
United States
Facility Name
Research Site
City
Summerville
State/Province
South Carolina
Country
United States
Facility Name
Research Site
City
Knoxville
State/Province
Tennessee
Country
United States
Facility Name
Research Site
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Research Site
City
Austin
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Baytown
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Fort Worth
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Georgetown
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Killeen
State/Province
Texas
Country
United States
Facility Name
Research Site
City
McKinney
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Pharr
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Plano
State/Province
Texas
Country
United States
Facility Name
Research Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Spring
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Sugar Land
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Sugarland
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Waco
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Layton
State/Province
Utah
Country
United States
Facility Name
Research Site
City
South Burlington
State/Province
Vermont
Country
United States
Facility Name
Research Site
City
Danville
State/Province
Virginia
Country
United States
Facility Name
Research Site
City
Vienna
State/Province
Virginia
Country
United States
Facility Name
Research Site
City
Virginia Beach
State/Province
Virginia
Country
United States
Facility Name
Research Site
City
Seattle
State/Province
Washington
Country
United States
Facility Name
Research Site
City
Spokane
State/Province
Washington
Country
United States
Facility Name
Research Site
City
Tacoma
State/Province
Washington
Country
United States
Facility Name
Research Site
City
La Crosse
State/Province
Wisconsin
Country
United States
Facility Name
Research Site
City
Milwaukee
State/Province
Wisconsin
Country
United States
Facility Name
Research Site
City
Buenos Aires
Country
Argentina
Facility Name
Research Site
City
Ciudad de Buenos Aires
Country
Argentina
Facility Name
Research Site
City
Córdoba
Country
Argentina
Facility Name
Research Site
City
Mar del Plata
Country
Argentina
Facility Name
Research Site
City
Monte Grande
Country
Argentina
Facility Name
Research Site
City
Quilmes
Country
Argentina
Facility Name
Research Site
City
Ranelagh
Country
Argentina
Facility Name
Research Site
City
San Miguel de Tucuman
Country
Argentina
Facility Name
Research Site
City
San Miguel de Tucumán
Country
Argentina
Facility Name
Research Site
City
Barueri
Country
Brazil
Facility Name
Research Site
City
Botucatu
Country
Brazil
Facility Name
Research Site
City
Goiania
Country
Brazil
Facility Name
Research Site
City
Juiz de Fora
Country
Brazil
Facility Name
Research Site
City
Porto Alegre
Country
Brazil
Facility Name
Research Site
City
Santo André
Country
Brazil
Facility Name
Research Site
City
Sao Paulo
Country
Brazil
Facility Name
Research Site
City
Gotse Delchev
Country
Bulgaria
Facility Name
Research Site
City
Kozloduy
Country
Bulgaria
Facility Name
Research Site
City
Petrich
Country
Bulgaria
Facility Name
Research Site
City
Pleven
Country
Bulgaria
Facility Name
Research Site
City
Razgrad
Country
Bulgaria
Facility Name
Research Site
City
Razlog
Country
Bulgaria
Facility Name
Research Site
City
Ruse
Country
Bulgaria
Facility Name
Research Site
City
Sandanski
Country
Bulgaria
Facility Name
Research Site
City
Sevlievo
Country
Bulgaria
Facility Name
Research Site
City
Sofia
Country
Bulgaria
Facility Name
Research Site
City
Stara Zagora
Country
Bulgaria
Facility Name
Research Site
City
Varna
Country
Bulgaria
Facility Name
Research Site
City
Vidin
Country
Bulgaria
Facility Name
Research Site
City
Quillota
Country
Chile
Facility Name
Research Site
City
Santiago
Country
Chile
Facility Name
Research Site
City
Vina del Mar
Country
Chile
Facility Name
Research Site
City
Bogotá
Country
Colombia
Facility Name
Research Site
City
Cali
Country
Colombia
Facility Name
Research Site
City
Manizales
Country
Colombia
Facility Name
Research Site
City
Beroun
Country
Czech Republic
Facility Name
Research Site
City
Breclav
Country
Czech Republic
Facility Name
Research Site
City
Krnov
Country
Czech Republic
Facility Name
Research Site
City
Kutna Hora
Country
Czech Republic
Facility Name
Research Site
City
Litomerice
Country
Czech Republic
Facility Name
Research Site
City
Ostrava
Country
Czech Republic
Facility Name
Research Site
City
Plzen
Country
Czech Republic
Facility Name
Research Site
City
Praha 10
Country
Czech Republic
Facility Name
Research Site
City
Praha 4
Country
Czech Republic
Facility Name
Research Site
City
Praha 8
Country
Czech Republic
Facility Name
Research Site
City
Rokycany
Country
Czech Republic
Facility Name
Research Site
City
Angers
Country
France
Facility Name
Research Site
City
Perpignan
Country
France
Facility Name
Research Site
City
Tierce
Country
France
Facility Name
Research Site
City
Berlin
Country
Germany
Facility Name
Research Site
City
Hamburg
Country
Germany
Facility Name
Research Site
City
Leipzig
Country
Germany
Facility Name
Research Site
City
Marburg
Country
Germany
Facility Name
Research Site
City
Bangalore
Country
India
Facility Name
Research Site
City
Calicut
Country
India
Facility Name
Research Site
City
Coimbatore
Country
India
Facility Name
Research Site
City
Goa
Country
India
Facility Name
Research Site
City
Hyderabad
Country
India
Facility Name
Research Site
City
Mangalore
Country
India
Facility Name
Research Site
City
Mysore
Country
India
Facility Name
Research Site
City
Nagpur
Country
India
Facility Name
Research Site
City
New Delhi
Country
India
Facility Name
Research Site
City
Trivandrum
Country
India
Facility Name
Research Site
City
Benevento
Country
Italy
Facility Name
Research Site
City
Bologna
Country
Italy
Facility Name
Research Site
City
Catanzaro
Country
Italy
Facility Name
Research Site
City
Ferrara
Country
Italy
Facility Name
Research Site
City
Genova
Country
Italy
Facility Name
Research Site
City
Napoli
Country
Italy
Facility Name
Research Site
City
Padova
Country
Italy
Facility Name
Research Site
City
Palermo
Country
Italy
Facility Name
Research Site
City
Roma
Country
Italy
Facility Name
Research Site
City
Ansan-si
Country
Korea, Republic of
Facility Name
Research Site
City
Cheonan-si
Country
Korea, Republic of
Facility Name
Research Site
City
Cheongju-si
Country
Korea, Republic of
Facility Name
Research Site
City
Jinju-si
Country
Korea, Republic of
Facility Name
Research Site
City
Seongnam-si
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
Country
Korea, Republic of
Facility Name
Research Site
City
Durango
Country
Mexico
Facility Name
Research Site
City
Guadalajara
Country
Mexico
Facility Name
Research Site
City
Mexico
Country
Mexico
Facility Name
Research Site
City
Monterey
Country
Mexico
Facility Name
Research Site
City
Monterrey
Country
Mexico
Facility Name
Research Site
City
Morelia
Country
Mexico
Facility Name
Research Site
City
México
Country
Mexico
Facility Name
Research Site
City
Santiago de Querétaro
Country
Mexico
Facility Name
Research Site
City
Villahermosa
Country
Mexico
Facility Name
Research Site
City
Zapopan
Country
Mexico
Facility Name
Research Site
City
Ciudad de Panama
Country
Panama
Facility Name
Research Site
City
Cusco
Country
Peru
Facility Name
Research Site
City
Lima
Country
Peru
Facility Name
Research Site
City
Iloilo City
Country
Philippines
Facility Name
Research Site
City
Lipa City
Country
Philippines
Facility Name
Research Site
City
Manila
Country
Philippines
Facility Name
Research Site
City
Pasig City
Country
Philippines
Facility Name
Research Site
City
Quezon City
Country
Philippines
Facility Name
Research Site
City
Białystok
Country
Poland
Facility Name
Research Site
City
Bydgoszcz
Country
Poland
Facility Name
Research Site
City
Chęciny
Country
Poland
Facility Name
Research Site
City
Gorzów Wlkp
Country
Poland
Facility Name
Research Site
City
Karpacz
Country
Poland
Facility Name
Research Site
City
Kraków
Country
Poland
Facility Name
Research Site
City
Ostrów Wielkopolski
Country
Poland
Facility Name
Research Site
City
Skarżysko Kamienna
Country
Poland
Facility Name
Research Site
City
Strzelce Opolskie
Country
Poland
Facility Name
Research Site
City
Szczecin
Country
Poland
Facility Name
Research Site
City
Tarnów
Country
Poland
Facility Name
Research Site
City
Turek
Country
Poland
Facility Name
Research Site
City
Urszulin
Country
Poland
Facility Name
Research Site
City
Wrocław
Country
Poland
Facility Name
Research Site
City
Caguas
Country
Puerto Rico
Facility Name
Research Site
City
San Juan
Country
Puerto Rico
Facility Name
Research Site
City
Toa Baja
Country
Puerto Rico
Facility Name
Research Site
City
Bragadiru
Country
Romania
Facility Name
Research Site
City
Brasov
Country
Romania
Facility Name
Research Site
City
Bucharest
Country
Romania
Facility Name
Research Site
City
Bucuresti
Country
Romania
Facility Name
Research Site
City
Cluj Napoca
Country
Romania
Facility Name
Research Site
City
Constanta
Country
Romania
Facility Name
Research Site
City
Craiova
Country
Romania
Facility Name
Research Site
City
Deva
Country
Romania
Facility Name
Research Site
City
Iasi
Country
Romania
Facility Name
Research Site
City
Tg. Mures
Country
Romania
Facility Name
Research Site
City
Ekaterinburg
Country
Russian Federation
Facility Name
Research Site
City
Kazan
Country
Russian Federation
Facility Name
Research Site
City
Moscow
Country
Russian Federation
Facility Name
Research Site
City
Novosibirsk
Country
Russian Federation
Facility Name
Research Site
City
Penza
Country
Russian Federation
Facility Name
Research Site
City
Saint Petersburg
Country
Russian Federation
Facility Name
Research Site
City
Saint-Petersburg
Country
Russian Federation
Facility Name
Research Site
City
Saratov
Country
Russian Federation
Facility Name
Research Site
City
St-Petersburg
Country
Russian Federation
Facility Name
Research Site
City
St. Petersburg
Country
Russian Federation
Facility Name
Research Site
City
StPetersburg
Country
Russian Federation
Facility Name
Research Site
City
Vladikavkaz
Country
Russian Federation
Facility Name
Research Site
City
Volgograd
Country
Russian Federation
Facility Name
Research Site
City
Yaroslavl
Country
Russian Federation
Facility Name
Research Site
City
Yekaterinburg
Country
Russian Federation
Facility Name
Research Site
City
Bardejov
Country
Slovakia
Facility Name
Research Site
City
Bratislava
Country
Slovakia
Facility Name
Research Site
City
Dunajska Streda
Country
Slovakia
Facility Name
Research Site
City
Komarno
Country
Slovakia
Facility Name
Research Site
City
Kosice
Country
Slovakia
Facility Name
Research Site
City
Liptovsky Mikulas
Country
Slovakia
Facility Name
Research Site
City
Nitra
Country
Slovakia
Facility Name
Research Site
City
Presov
Country
Slovakia
Facility Name
Research Site
City
Ruzomberok
Country
Slovakia
Facility Name
Research Site
City
Skalica
Country
Slovakia
Facility Name
Research Site
City
Zilina
Country
Slovakia
Facility Name
Research Site
City
Zvolen
Country
Slovakia
Facility Name
Research Site
City
Boksburg North
Country
South Africa
Facility Name
Research Site
City
Breyton
Country
South Africa
Facility Name
Research Site
City
Cape Town
Country
South Africa
Facility Name
Research Site
City
Durban
Country
South Africa
Facility Name
Research Site
City
Johannesburg
Country
South Africa
Facility Name
Research Site
City
Lenasia
Country
South Africa
Facility Name
Research Site
City
Lyttleton
Country
South Africa
Facility Name
Research Site
City
Pretoria
Country
South Africa
Facility Name
Research Site
City
Umkomaas
Country
South Africa
Facility Name
Research Site
City
Verulam
Country
South Africa
Facility Name
Research Site
City
Bangkok
Country
Thailand
Facility Name
Research Site
City
Hat Yai
Country
Thailand
Facility Name
Research Site
City
Khon Kaen
Country
Thailand
Facility Name
Research Site
City
Muang,
Country
Thailand
Facility Name
Research Site
City
Naimuang
Country
Thailand
Facility Name
Research Site
City
Dnipropetrovsk
Country
Ukraine
Facility Name
Research Site
City
Donetsk
Country
Ukraine
Facility Name
Research Site
City
Ivano-Frankivsk
Country
Ukraine
Facility Name
Research Site
City
Kharkiv
Country
Ukraine
Facility Name
Research Site
City
Kiev
Country
Ukraine
Facility Name
Research Site
City
Odesa
Country
Ukraine
Facility Name
Research Site
City
Poltava
Country
Ukraine
Facility Name
Research Site
City
Uzhgorod
Country
Ukraine
Facility Name
Research Site
City
Vinnitsa
Country
Ukraine
Facility Name
Research Site
City
Zaporozye
Country
Ukraine
Facility Name
Research Site
City
Bath
Country
United Kingdom
Facility Name
Research Site
City
Belfast
Country
United Kingdom
Facility Name
Research Site
City
Blackpool
Country
United Kingdom
Facility Name
Research Site
City
Canterbury
Country
United Kingdom
Facility Name
Research Site
City
Chippenham
Country
United Kingdom
Facility Name
Research Site
City
Coventry
Country
United Kingdom
Facility Name
Research Site
City
Crawley
Country
United Kingdom
Facility Name
Research Site
City
Leamington Spa
Country
United Kingdom
Facility Name
Research Site
City
Leicester
Country
United Kingdom
Facility Name
Research Site
City
Stockport
Country
United Kingdom
Facility Name
Research Site
City
Trowbridge
Country
United Kingdom
Facility Name
Research Site
City
Watford
Country
United Kingdom
Facility Name
Research Site
City
Westbury
Country
United Kingdom
Facility Name
Research Site
City
Hanoi
Country
Vietnam
Facility Name
Research Site
City
Ho Chi Minh
Country
Vietnam

12. IPD Sharing Statement

Citations:
PubMed Identifier
27579635
Citation
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.
Results Reference
derived
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=541&filename=D5896C00027_Protocol_redacted.pdf
Description
D5896C00027_Protocol_redacted.pdf

Learn more about this trial

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

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