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A Comparison of Symbicort® pMDI 2 x 160/4.5 μg Bid and 2 x 80/4.5 μg Bid With Formoterol Turbuhaler® 2 x 4.5 μg Bid and Placebo in Patients With COPD

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Budesonide/formoterol pMDI
Formoterol Turbuhaler
Sponsored by
AstraZeneca
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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Outcomes

Primary Outcome Measures

Pre-dose and 1-hour post-dose FEV1 over the 12 months treatment period

Secondary Outcome Measures

Patient-reported outcome variables regarding disease status (incl. PEF), collected via questionnaires and diaries
Health care utilization
Safety variables, including adverse events, vital signs, ECG, physical examination, hematology, and clinical chemistry.
all variables assessed over the 12 months treatment period

Full Information

First Posted
September 13, 2005
Last Updated
March 26, 2009
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00206167
Brief Title
A Comparison of Symbicort® pMDI 2 x 160/4.5 μg Bid and 2 x 80/4.5 μg Bid With Formoterol Turbuhaler® 2 x 4.5 μg Bid and Placebo in Patients With COPD
Official Title
A 12-Month Double-Blind, Double-Dummy, Randomized, Parallel Group, Multicenter Efficacy and Safety Study of Symbicort® pMDI 2 x 160/4.5 μg Bid and 2 x 80/4.5 μg Bid Compared to Formoterol Turbuhaler® 2 x 4.5 μg Bid and Placebo in Patients With COPD
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
September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to compare Symbicort in a pressurized metered-dose inhaler (pMDI) with formoterol and 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
1600 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Budesonide/formoterol pMDI
Intervention Type
Drug
Intervention Name(s)
Formoterol Turbuhaler
Primary Outcome Measure Information:
Title
Pre-dose and 1-hour post-dose FEV1 over the 12 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
Safety variables, including adverse events, vital signs, ECG, physical examination, hematology, and clinical chemistry.
Title
all variables assessed over the 12 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
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Birmingham
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Denmark
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Cottbus
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Germany
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Münster
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Germany
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Dresden
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Germany
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Germany
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Bad Salzungen
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Germany
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Germany
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Bonn
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Germany
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Germany
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Germany
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Germany
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City
Budapest
Country
Hungary
Facility Name
Research Site
City
Cegled
Country
Hungary
Facility Name
Research Site
City
Deszk
Country
Hungary
Facility Name
Research Site
City
Erd
Country
Hungary
Facility Name
Research Site
City
Fuzesabony
Country
Hungary
Facility Name
Research Site
City
Godolli
Country
Hungary
Facility Name
Research Site
City
Gyor
Country
Hungary
Facility Name
Research Site
City
Gyula
Country
Hungary
Facility Name
Research Site
City
Gyöngyös
Country
Hungary
Facility Name
Research Site
City
Jaszbereny
Country
Hungary
Facility Name
Research Site
City
Keszthely
Country
Hungary
Facility Name
Research Site
City
Kiskunhalas
Country
Hungary
Facility Name
Research Site
City
Mosdos
Country
Hungary
Facility Name
Research Site
City
Mosonmagyarovar
Country
Hungary
Facility Name
Research Site
City
Nógrádgárdony
Country
Hungary
Facility Name
Research Site
City
Pecs
Country
Hungary
Facility Name
Research Site
City
Salgótarján
Country
Hungary
Facility Name
Research Site
City
Siofok
Country
Hungary
Facility Name
Research Site
City
Szarvas
Country
Hungary
Facility Name
Research Site
City
Szazhalombatta
Country
Hungary
Facility Name
Research Site
City
Szeged
Country
Hungary
Facility Name
Research Site
City
Szombathely
Country
Hungary
Facility Name
Research Site
City
Sárvár
Country
Hungary
Facility Name
Research Site
City
Tatabanya
Country
Hungary
Facility Name
Research Site
City
Törökbálint
Country
Hungary
Facility Name
Research Site
City
Veszprem
Country
Hungary
Facility Name
Research Site
City
Zalaegerszeg-Pozva
Country
Hungary
Facility Name
Research Site
City
Zalaegerszeg
Country
Hungary
Facility Name
Research Site
City
Reykjavik
Country
Iceland
Facility Name
Research Site
City
Mexico City
State/Province
D.f.
Country
Mexico
Facility Name
Research Site
City
Guadalajara
State/Province
Jalisco
Country
Mexico
Facility Name
Research Site
City
Monterrey
State/Province
Nuevo León
Country
Mexico
Facility Name
Research Site
City
Brasov
Country
Romania
Facility Name
Research Site
City
Bucharest
Country
Romania
Facility Name
Research Site
City
Deva
Country
Romania
Facility Name
Research Site
City
Iasi
Country
Romania

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 2 x 80/4.5 μg Bid With Formoterol Turbuhaler® 2 x 4.5 μg Bid and Placebo in Patients With COPD

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