Back to resultsA Comparison of Symbicort® pMDI 2 x 160/4.5 μg Bid and Symbicort® pMDI 2 x 80/4.5 μg Bid With Formoterol Turbuhaler®, Budesonide pMDI, the Combination of Formoterol Turbuhaler® and Budesonide pMDI, and Placebo in COPD Patients
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Budesonide/formoterol pMDI
Budesonide pMDI
Formoterol Turbuhaler
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease
Eligibility Criteria
Inclusion Criteria: A clinical diagnosis of COPD with symptoms for more than 2 years Smoking history of 10 or more pack years A history of at least one COPD exacerbation requiring a course of oral steroids and/or antibiotics within 1-12 months before first visit. Exclusion Criteria: A history of asthma Patients taking oral steroids. Any significant disease or disorder that may jeopardize the safety of the patient
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
Outcomes
Primary Outcome Measures
Pre-dose and 1-hour post-dose FEV1 over the 6 months treatment period
Secondary Outcome Measures
Patient-reported outcome variables regarding disease status (incl. PEF), collected via questionnaires and diaries
Health care utilization
Pharmacokinetics (subgroup)
Safety variables, including adverse events, vital signs, ECG, physical examination, hematology, and clinical chemistry.
- all variables assessed over the 6 months treatment period
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00206154
Brief Title
A Comparison of Symbicort® pMDI 2 x 160/4.5 μg Bid and Symbicort® pMDI 2 x 80/4.5 μg Bid With Formoterol Turbuhaler®, Budesonide pMDI, the Combination of Formoterol Turbuhaler® and Budesonide pMDI, and Placebo in COPD Patients
Official Title
A 6-Month Double-Blind, Double-Dummy, Randomized, Parallel Group, Multicenter Efficacy & Safety Study of SYMBICORT® pMDI 2 x 160/4.5 µg & 80/4.5 µg Bid Compared to Formoterol TBH, Budesonide pMDI (& the Combination) & Placebo in COPD Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to compare a combination asthma drug (Symbicort) with its two components, budesonide and formoterol, taken individually or in combination, and with placebo in the long-term maintenance treatment of patients with chronic obstructive pulmonary disease (COPD)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
1500 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Budesonide/formoterol pMDI
Intervention Type
Drug
Intervention Name(s)
Budesonide pMDI
Intervention Type
Drug
Intervention Name(s)
Formoterol Turbuhaler
Primary Outcome Measure Information:
Title
Pre-dose and 1-hour post-dose FEV1 over the 6 months treatment period
Secondary Outcome Measure Information:
Title
Patient-reported outcome variables regarding disease status (incl. PEF), collected via questionnaires and diaries
Title
Health care utilization
Title
Pharmacokinetics (subgroup)
Title
Safety variables, including adverse events, vital signs, ECG, physical examination, hematology, and clinical chemistry.
Title
- all variables assessed over the 6 months treatment period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
A clinical diagnosis of COPD with symptoms for more than 2 years
Smoking history of 10 or more pack years
A history of at least one COPD exacerbation requiring a course of oral steroids and/or antibiotics within 1-12 months before first visit.
Exclusion Criteria:
A history of asthma
Patients taking oral steroids.
Any significant disease or disorder that may jeopardize the safety of the patient
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Symbicort Medical Science Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Research Site
City
Jasper
State/Province
Alabama
Country
United States
Facility Name
Research Site
City
Mobile
State/Province
Alabama
Country
United States
Facility Name
Research Site
City
Glendale
State/Province
Arizona
Country
United States
Facility Name
Research Site
City
Mesa
State/Province
Arizona
Country
United States
Facility Name
Research Site
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
Research Site
City
Fort Smith
State/Province
Arkansas
Country
United States
Facility Name
Research Site
City
Little Rock
State/Province
Arkansas
Country
United States
Facility Name
Research Site
City
Searcy
State/Province
Arkansas
Country
United States
Facility Name
Research Site
City
Anaheim
State/Province
California
Country
United States
Facility Name
Research Site
City
Fullerton
State/Province
California
Country
United States
Facility Name
Research Site
City
Irvine
State/Province
California
Country
United States
Facility Name
Research Site
City
Long Beach
State/Province
California
Country
United States
Facility Name
Research Site
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Research Site
City
Mission Viejo
State/Province
California
Country
United States
Facility Name
Research Site
City
Orange
State/Province
California
Country
United States
Facility Name
Research Site
City
Rancho Cordova
State/Province
California
Country
United States
Facility Name
Research Site
City
Riverside
State/Province
California
Country
United States
Facility Name
Research Site
City
San Diego
State/Province
California
Country
United States
Facility Name
Research Site
City
San Jose
State/Province
California
Country
United States
Facility Name
Research Site
City
Sepulveda
State/Province
California
Country
United States
Facility Name
Research Site
City
Signal Hill
State/Province
California
Country
United States
Facility Name
Research Site
City
Stockton
State/Province
California
Country
United States
Facility Name
Research Site
City
Torrance
State/Province
California
Country
United States
Facility Name
Research Site
City
Walnut Creek
State/Province
California
Country
United States
Facility Name
Research Site
City
Colorado Springs
State/Province
Colorado
Country
United States
Facility Name
Research Site
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Research Site
City
Wheat Ridge
State/Province
Colorado
Country
United States
Facility Name
Research Site
City
Bristol
State/Province
Connecticut
Country
United States
Facility Name
Research Site
City
Waterbury
State/Province
Connecticut
Country
United States
Facility Name
Research Site
City
Bay Pines
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Brandon
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Clearwater
State/Province
Florida
Country
United States
Facility Name
Research Site
City
DeLand
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Largo
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Miami Beach
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Naples
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Ocala
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Ormond Beach
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Panama City
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Pembroke Pines
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Port Orange
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Sarasota
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Blairsville
State/Province
Georgia
Country
United States
Facility Name
Research Site
City
Blue Ridge
State/Province
Georgia
Country
United States
Facility Name
Research Site
City
Marietta
State/Province
Georgia
Country
United States
Facility Name
Research Site
City
Rome
State/Province
Georgia
Country
United States
Facility Name
Research Site
City
Coeur d'Alene
State/Province
Idaho
Country
United States
Facility Name
Research Site
City
Bloomington
State/Province
Illinois
Country
United States
Facility Name
Research Site
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Research Site
City
Hines
State/Province
Illinois
Country
United States
Facility Name
Research Site
City
Normal
State/Province
Illinois
Country
United States
Facility Name
Research Site
City
North Chicago
State/Province
Illinois
Country
United States
Facility Name
Research Site
City
O'Fallon
State/Province
Illinois
Country
United States
Facility Name
Research Site
City
Evansville
State/Province
Indiana
Country
United States
Facility Name
Research Site
City
South Bend
State/Province
Indiana
Country
United States
Facility Name
Research Site
City
Iowa City
State/Province
Iowa
Country
United States
Facility Name
Research Site
City
Waterloo
State/Province
Iowa
Country
United States
Facility Name
Research Site
City
Mission
State/Province
Kansas
Country
United States
Facility Name
Research Site
City
Wichita
State/Province
Kansas
Country
United States
Facility Name
Research Site
City
Lebanon
State/Province
Kentucky
Country
United States
Facility Name
Research Site
City
Louisville
State/Province
Kentucky
Country
United States
Facility Name
Research Site
City
Madisonville
State/Province
Kentucky
Country
United States
Facility Name
Research Site
City
Paducah
State/Province
Kentucky
Country
United States
Facility Name
Research Site
City
Baton Rouge
State/Province
Louisiana
Country
United States
Facility Name
Research Site
City
Lafayette
State/Province
Louisiana
Country
United States
Facility Name
Research Site
City
Marrero
State/Province
Louisiana
Country
United States
Facility Name
Research Site
City
New Orleans
State/Province
Louisiana
Country
United States
Facility Name
Research Site
City
Shreveport
State/Province
Louisiana
Country
United States
Facility Name
Research Site
City
Sunset
State/Province
Louisiana
Country
United States
Facility Name
Research Site
City
Auburn
State/Province
Maine
Country
United States
Facility Name
Research Site
City
Bangor
State/Province
Maine
Country
United States
Facility Name
Research Site
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Research Site
City
Taunton
State/Province
Massachusetts
Country
United States
Facility Name
Research Site
City
Minneapolis
State/Province
Minnesota
Country
United States
Facility Name
Research Site
City
Plymouth
State/Province
Minnesota
Country
United States
Facility Name
Research Site
City
St Paul
State/Province
Minnesota
Country
United States
Facility Name
Research Site
City
Chesterfield
State/Province
Missouri
Country
United States
Facility Name
Research Site
City
St. Charles
State/Province
Missouri
Country
United States
Facility Name
Research Site
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
Research Site
City
Butte
State/Province
Montana
Country
United States
Facility Name
Research Site
City
Missoula
State/Province
Montana
Country
United States
Facility Name
Research Site
City
Omaha
State/Province
Nebraska
Country
United States
Facility Name
Research Site
City
Papillion
State/Province
Nebraska
Country
United States
Facility Name
Research Site
City
Scottsbluff
State/Province
Nebraska
Country
United States
Facility Name
Research Site
City
Las Vegas
State/Province
Nevada
Country
United States
Facility Name
Research Site
City
Pahrump
State/Province
Nevada
Country
United States
Facility Name
Research Site
City
Reno
State/Province
Nevada
Country
United States
Facility Name
Research Site
City
Cherry Hill
State/Province
New Jersey
Country
United States
Facility Name
Research Site
City
Skillman
State/Province
New Jersey
Country
United States
Facility Name
Research Site
City
Springfield
State/Province
New Jersey
Country
United States
Facility Name
Research Site
City
Albuquerque
State/Province
New Mexico
Country
United States
Facility Name
Research Site
City
Bay Shore
State/Province
New York
Country
United States
Facility Name
Research Site
City
Buffalo
State/Province
New York
Country
United States
Facility Name
Research Site
City
Larchmont
State/Province
New York
Country
United States
Facility Name
Research Site
City
Mineola
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
Chapel Hill
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Raleigh
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
Bismarck
State/Province
North Dakota
Country
United States
Facility Name
Research Site
City
Akron
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Mogadore
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Sylvania
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Zanesville
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Research Site
City
Eugene
State/Province
Oregon
Country
United States
Facility Name
Research Site
City
Medford
State/Province
Oregon
Country
United States
Facility Name
Research Site
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Research Site
City
Easton
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Erie
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Hershey
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Ridley Park
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Swarthmore
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
West Chester
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
East Providence
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
Simpsonville
State/Province
South Carolina
Country
United States
Facility Name
Research Site
City
Spartanburg
State/Province
South Carolina
Country
United States
Facility Name
Research Site
City
Austin
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Barker
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Research Site
City
El Paso
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Fort Worth
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
New Braunfels
State/Province
Texas
Country
United States
Facility Name
Research Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Abingdon
State/Province
Virginia
Country
United States
Facility Name
Research Site
City
Charlottesville
State/Province
Virginia
Country
United States
Facility Name
Research Site
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
Research Site
City
Salem
State/Province
Virginia
Country
United States
Facility Name
Research Site
City
Virginia Beach
State/Province
Virginia
Country
United States
Facility Name
Research Site
City
Bellingham
State/Province
Washington
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
Praha 8
State/Province
CZ
Country
Czech Republic
Facility Name
Research Site
City
Ústí nad Labem
State/Province
CZ
Country
Czech Republic
Facility Name
Research Site
City
Beroun
Country
Czech Republic
Facility Name
Research Site
City
Cvikov
Country
Czech Republic
Facility Name
Research Site
City
Jarom¿¿
Country
Czech Republic
Facility Name
Research Site
City
Karlovy Vary
Country
Czech Republic
Facility Name
Research Site
City
Kladno
Country
Czech Republic
Facility Name
Research Site
City
Kutná Hora
Country
Czech Republic
Facility Name
Research Site
City
Liberec
Country
Czech Republic
Facility Name
Research Site
City
Lovosice
Country
Czech Republic
Facility Name
Research Site
City
Neratovice
Country
Czech Republic
Facility Name
Research Site
City
Olomouc
Country
Czech Republic
Facility Name
Research Site
City
Ostrava 1
Country
Czech Republic
Facility Name
Research Site
City
Plzen
Country
Czech Republic
Facility Name
Research Site
City
Praha 1
Country
Czech Republic
Facility Name
Research Site
City
Praha 2
Country
Czech Republic
Facility Name
Research Site
City
Praha 5
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
Strakonice
Country
Czech Republic
Facility Name
Research Site
City
Znojmo
Country
Czech Republic
Facility Name
Research Site
City
Ústí nad Labem
Country
Czech Republic
Facility Name
Research Site
City
Almelo
Country
Netherlands
Facility Name
Research Site
City
Arnhem
Country
Netherlands
Facility Name
Research Site
City
Breda
Country
Netherlands
Facility Name
Research Site
City
Den Haag
Country
Netherlands
Facility Name
Research Site
City
Eindhoven
Country
Netherlands
Facility Name
Research Site
City
Groningen
Country
Netherlands
Facility Name
Research Site
City
Harderwijk
Country
Netherlands
Facility Name
Research Site
City
Heerlen
Country
Netherlands
Facility Name
Research Site
City
Nieuwegein
Country
Netherlands
Facility Name
Research Site
City
Terneuzen
Country
Netherlands
Facility Name
Research Site
City
Tilburg
Country
Netherlands
Facility Name
Research Site
City
Utrecht
Country
Netherlands
Facility Name
Research Site
City
Bia¿ystok
Country
Poland
Facility Name
Research Site
City
Bydgoszcz
Country
Poland
Facility Name
Research Site
City
Bystra ¿l¿ska
Country
Poland
Facility Name
Research Site
City
Chrzanów
Country
Poland
Facility Name
Research Site
City
Ch¿ciny
Country
Poland
Facility Name
Research Site
City
Cz¿stochowa
Country
Poland
Facility Name
Research Site
City
Gidle
Country
Poland
Facility Name
Research Site
City
Gorzów Wlkp
Country
Poland
Facility Name
Research Site
City
I¿awa
Country
Poland
Facility Name
Research Site
City
Karpacz
Country
Poland
Facility Name
Research Site
City
Kraków
Country
Poland
Facility Name
Research Site
City
Lublin
Country
Poland
Facility Name
Research Site
City
Ostrów Wielkopolski
Country
Poland
Facility Name
Research Site
City
Otowck
Country
Poland
Facility Name
Research Site
City
Pozna¿
Country
Poland
Facility Name
Research Site
City
Proszowice
Country
Poland
Facility Name
Research Site
City
Radom
Country
Poland
Facility Name
Research Site
City
Siedlce
Country
Poland
Facility Name
Research Site
City
Sopot
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
Warszawa
Country
Poland
Facility Name
Research Site
City
Wo¿omin
Country
Poland
Facility Name
Research Site
City
Zabrze
Country
Poland
Facility Name
Research Site
City
Zawadzkie
Country
Poland
Facility Name
Research Site
City
¿om¿a
Country
Poland
Facility Name
Research Site
City
¿ód¿
Country
Poland
Facility Name
Research Site
City
Parow
State/Province
Cape Province
Country
South Africa
Facility Name
Research Site
City
Lenasia
State/Province
Gauteng
Country
South Africa
Facility Name
Research Site
City
Pretoria
State/Province
Gauteng
Country
South Africa
Facility Name
Research Site
City
Witbank
State/Province
Gauteng
Country
South Africa
Facility Name
Research Site
City
Cape Town
State/Province
Western Cape
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
Lyttelton Manor
Country
South Africa
Facility Name
Research Site
City
Port Elizabeth
Country
South Africa
Facility Name
Research Site
City
Umkomaas
Country
South Africa
12. IPD Sharing Statement
Citations:
PubMed Identifier
29331313
Citation
Bafadhel M, Peterson S, De Blas MA, Calverley PM, Rennard SI, Richter K, Fageras M. Predictors of exacerbation risk and response to budesonide in patients with chronic obstructive pulmonary disease: a post-hoc analysis of three randomised trials. Lancet Respir Med. 2018 Feb;6(2):117-126. doi: 10.1016/S2213-2600(18)30006-7. Epub 2018 Jan 10.
Results Reference
derived
PubMed Identifier
25670896
Citation
Make BJ, Eriksson G, Calverley PM, Jenkins CR, Postma DS, Peterson S, Ostlund O, Anzueto A. A score to predict short-term risk of COPD exacerbations (SCOPEX). Int J Chron Obstruct Pulmon Dis. 2015 Jan 27;10:201-9. doi: 10.2147/COPD.S69589. eCollection 2015.
Results Reference
derived
PubMed Identifier
22383665
Citation
Bleecker ER, Meyers DA, Bailey WC, Sims AM, Bujac SR, Goldman M, Martin UJ. ADRB2 polymorphisms and budesonide/formoterol responses in COPD. Chest. 2012 Aug;142(2):320-328. doi: 10.1378/chest.11-1655.
Results Reference
derived
Learn more about this trial
A Comparison of Symbicort® pMDI 2 x 160/4.5 μg Bid and Symbicort® pMDI 2 x 80/4.5 μg Bid With Formoterol Turbuhaler®, Budesonide pMDI, the Combination of Formoterol Turbuhaler® and Budesonide pMDI, and Placebo in COPD Patients
We'll reach out to this number within 24 hrs