Back to resultsEvaluation of Efficacy and Safety of Symbicort® as an add-on Treatment to Spiriva® in Patients With Severe COPD.
Primary Purpose
Chronic Obstructive Pulmonary Disease, COPD
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Symbicort (budesonide/formoterol turbuhaler 320/9ug)
Spiriva (tiotropium bromide 18ug)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease, COPD focused on measuring Chronic Obstructive Pulmonary Disease, COPD
Eligibility Criteria
Inclusion Criteria:
- >=40 years of age, diagnosed COPD with symptoms >=2 years, pre-bronchodilatory FEV1 <=50% of PN
Exclusion Criteria:
- Current respiratory tract disorder other than COPD, history of asthma or rhinitis, significant or unstable cardiovascular disorder
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
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Symbicort+TIO
Spiriva® + Placebo Turbuhaler
Arm Description
Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
Outcomes
Primary Outcome Measures
Forced Expiratory Volume in 1 Second (FEV1) Pre-dose
Change in the pre-dose FEV1from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12)
Secondary Outcome Measures
Forced Expiratory Volume in 1 Second (FEV1) 5 Min Post-dose
Change in the 5 min post-dose FEV1from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12)
Forced Expiratory Volume in 1 Second (FEV1) 60 Min Post-dose
Change in the 60 min post-dose FEV1from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12)
Forced Vital Capacity (FVC) Pre-dose
Change in the pre-dose FVC from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12)
Forced Vital Capacity (FVC) 5 Minutes Post-dose
Change in the 5 min post-dose FVC from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12)
Forced Vital Capacity (FVC) 60 Minutes Post-dose
Change in the 60 min post-dose FVC from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12
Inspiratory Capacity (IC) Pre-dose
Change in the pre-dose IC from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12)
Inspiratory Capacity (IC) 60 Minutes Post-dose
Change in the 60 min post-dose IC from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12)
St George's Respiratory Questionnaire for COPD Patients (SGRQ-C) Score
Change in total score from baseline (Visit 3) to end of treatment (Visit 6, or last available visit).
SGRQ-C is a health related quality of life questionnaire consisting of 40 items divided into two components: 1) symptoms, 2) activity& impacts. The lowest possible value is zero and the highest 100. Higher values correspond to greater impairment in quality of life.
Morning Peak Expiratory Flow (PEF) Pre-dose
Daily diary record. Change in average values from run-in to the full treatment period
Evening Peak Expiratory Flow (PEF) Pre-dose
Daily diary record. Change in average values from run-in to the full treatment period
Morning Peak Expiratory Flow (PEF) 5 Min Post-dose
Daily diary record. Change in average values from run-in to the full treatment period
Morning Peak Expiratory Flow (PEF) 15 Min Post-dose
Daily diary record. Change in average values from run-in to the full treatment period
Morning Diary FEV1 Pre-dose
Daily diary record. Change in average values from run-in to the full treatment period
Evening Diary FEV1, Pre-dose
Daily diary record. Change in average values from run-in to the full treatment period
Morning Diary FEV1, 5 Minutes Post-dose
Daily diary record. Change in average values from run-in to the full treatment period
Morning Diary FEV1, 15 Minutes Post-dose
Daily diary record. Change in average values from run-in to the full treatment period
Global Chest Symptoms Questionnaire (GCSQ) Score, Pre-dose
Daily diary record. Change in average values from run-in to the full treatment period.
The GCSQ consisted of two questions that required the patient to rate shortness of breath and feelings of chest tightness. The patients recorded their response on a five-point Likert-type scale ranging from 0 (not at all) to 4 (extremely), the total score being calculated as the average score of the two questions.
GCSQ Score, 5 Minutes Post-dose
Daily diary record. Change in average values from run-in to the full treatment period.
The GCSQ consisted of two questions that required the patient to rate shortness of breath and feelings of chest tightness. The patients recorded their response on a five-point Likert-type scale ranging from 0 (not at all) to 4 (extremely), the total score being calculated as the average score of the two questions.
GCSQ Score, 15 Minutes Post-dose
Daily diary record. Change in average values from run-in to the full treatment period.
The GCSQ consisted of two questions that required the patient to rate shortness of breath and feelings of chest tightness. The patients recorded their response on a five-point Likert-type scale ranging from 0 (not at all) to 4 (extremely), the total score being calculated as the average score of the two questions.
Capacity of Day Living in the Morning (CDLM) Score
Daily diary record. Change in average values from run-in to the full treatment period.
The CDLM questionnaire is as a questionnaire to report on patient's ability to carry out each of six different morning activities (score ranging from 0 "not performed" to 1"performed") and rank the difficulty of performing each of those activities (score ranging from 0 "so difficult that the activity could not be carried out by the patient on their own" to 5 "activity was not at all difficult to carry out". Total score for each morning activity range from 0-6. Total score for whole CDLM questionnaire range from 0-36.
Use of Rescue Medication, Night
Daily diary record - Night, after evening measurement till morning. Change in average values from run-in to the full treatment period
Use of Rescue Medication, Morning
Daily diary record - Morning, after morning measurement till midday. Change in average values from run-in to the full treatment period
Use of Rescue Medication, Day
Daily diary record - Day, after morning measurement till evening. Change in average values from run-in to the full treatment period
Use of Rescue Medication, Total
Daily diary record - Total, 24 hours, during the night, and during the day. Change in average values from run-in to the full treatment period
COPD Symptoms, Breathing Score
Daily diary record. Change in average values from run-in to the full treatment period. Symptom scale 0 - 4 (0) None (1) Mild (2) Moderate (3) Marked (4) Severe
COPD Symptoms, Sleeping Score
Daily diary record. Change in average values from run-in to the full treatment period. Symptom scale 0 - 4 (0) None (1) Mild (2) Moderate (3) Marked (4) Severe
COPD Symptoms, Chest Score
Daily diary record. Change in average values from run-in to the full treatment period. Symptom scale 0 - 4 (0) None (1) Mild (2) Moderate (3) Marked (4) Severe
COPD Symptoms, Cough Score
Daily diary record. Change in average values from run-in to the full treatment period. Symptom scale 0 - 4 (0) None (1) Mild (2) Moderate (3) Marked (4) Severe
Severe COPD Exacerbations
Patients with worsening of COPD leading to treatment with systemic steroids (oral or parenteral), emergency room treatment or hospitalisation
Serum High-sensitivity C-reactive Protein (hsCRP)
Ratio of treatment period mean to run-in value
Serum Interleukin 6 (IL-6)
Ratio of treatment period mean to run-in value
Serum Interleukin 8 (IL-8)
Ratio of treatment period mean to run-in value
Serum Monocyte Chemoattractant Protein-1 (MCP-1)
Ratio of treatment period mean to run-in value
Serum Soluble Tumor Necrosis Factor-alpha (sTNF-alpha)
Ratio of treatment period mean to run-in value
Serum Tumor Necrosis Factor-alpha (TNF-alpha)
Ratio of treatment period mean to run-in value
Serum Vascular Cell Adhesion Molecule-1 (VCAM-1)
Ratio of treatment period mean to run-in value
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00496470
Brief Title
Evaluation of Efficacy and Safety of Symbicort® as an add-on Treatment to Spiriva® in Patients With Severe COPD.
Official Title
A 12-week, Double-blind, Randomised, Parallel Group, Multi-centre, Study to Evaluate Efficacy and Safety of Budesonide/Formoterol (Symbicort Turbuhaler®) 320/9 µg One Inhalation Twice Daily on Top of Tiotropium (Spiriva®) 18 µg One Inhalation Once Daily
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (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 this study is to investigate the effect of combined treatment with Symbicort and Spiriva, in terms of improvement of lung function, symptoms and inflammatory markers, in patients with severe COPD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, COPD
Keywords
Chronic Obstructive Pulmonary Disease, COPD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
660 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Symbicort+TIO
Arm Type
Active Comparator
Arm Description
Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
Arm Title
Spiriva® + Placebo Turbuhaler
Arm Type
Active Comparator
Arm Description
Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
Intervention Type
Drug
Intervention Name(s)
Symbicort (budesonide/formoterol turbuhaler 320/9ug)
Intervention Description
Symbicort (budesonide/formoterol turbuhaler 320/9ug)
Intervention Type
Drug
Intervention Name(s)
Spiriva (tiotropium bromide 18ug)
Intervention Description
Spiriva (tiotropium bromide 18ug)
Primary Outcome Measure Information:
Title
Forced Expiratory Volume in 1 Second (FEV1) Pre-dose
Description
Change in the pre-dose FEV1from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12)
Time Frame
Baseline to 12 weeks
Secondary Outcome Measure Information:
Title
Forced Expiratory Volume in 1 Second (FEV1) 5 Min Post-dose
Description
Change in the 5 min post-dose FEV1from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12)
Time Frame
Baseline to 12 weeks
Title
Forced Expiratory Volume in 1 Second (FEV1) 60 Min Post-dose
Description
Change in the 60 min post-dose FEV1from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12)
Time Frame
Baseline to 12 weeks
Title
Forced Vital Capacity (FVC) Pre-dose
Description
Change in the pre-dose FVC from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12)
Time Frame
Baseline to 12 weeks
Title
Forced Vital Capacity (FVC) 5 Minutes Post-dose
Description
Change in the 5 min post-dose FVC from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12)
Time Frame
Baseline to 12 weeks
Title
Forced Vital Capacity (FVC) 60 Minutes Post-dose
Description
Change in the 60 min post-dose FVC from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12
Time Frame
Baseline to 12 weeks
Title
Inspiratory Capacity (IC) Pre-dose
Description
Change in the pre-dose IC from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12)
Time Frame
Baseline to 12 weeks
Title
Inspiratory Capacity (IC) 60 Minutes Post-dose
Description
Change in the 60 min post-dose IC from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12)
Time Frame
Baseline to 12 weeks
Title
St George's Respiratory Questionnaire for COPD Patients (SGRQ-C) Score
Description
Change in total score from baseline (Visit 3) to end of treatment (Visit 6, or last available visit).
SGRQ-C is a health related quality of life questionnaire consisting of 40 items divided into two components: 1) symptoms, 2) activity& impacts. The lowest possible value is zero and the highest 100. Higher values correspond to greater impairment in quality of life.
Time Frame
Baseline and 12 weeks
Title
Morning Peak Expiratory Flow (PEF) Pre-dose
Description
Daily diary record. Change in average values from run-in to the full treatment period
Time Frame
Baseline to 12 weeks
Title
Evening Peak Expiratory Flow (PEF) Pre-dose
Description
Daily diary record. Change in average values from run-in to the full treatment period
Time Frame
Baseline to 12 weeks
Title
Morning Peak Expiratory Flow (PEF) 5 Min Post-dose
Description
Daily diary record. Change in average values from run-in to the full treatment period
Time Frame
Baseline to 12 weeks
Title
Morning Peak Expiratory Flow (PEF) 15 Min Post-dose
Description
Daily diary record. Change in average values from run-in to the full treatment period
Time Frame
Baseline to 12 weeks
Title
Morning Diary FEV1 Pre-dose
Description
Daily diary record. Change in average values from run-in to the full treatment period
Time Frame
Baseline to 12 weeks
Title
Evening Diary FEV1, Pre-dose
Description
Daily diary record. Change in average values from run-in to the full treatment period
Time Frame
Baseline to 12 weeks
Title
Morning Diary FEV1, 5 Minutes Post-dose
Description
Daily diary record. Change in average values from run-in to the full treatment period
Time Frame
Baseline to 12 weeks
Title
Morning Diary FEV1, 15 Minutes Post-dose
Description
Daily diary record. Change in average values from run-in to the full treatment period
Time Frame
Baseline to 12 weeks
Title
Global Chest Symptoms Questionnaire (GCSQ) Score, Pre-dose
Description
Daily diary record. Change in average values from run-in to the full treatment period.
The GCSQ consisted of two questions that required the patient to rate shortness of breath and feelings of chest tightness. The patients recorded their response on a five-point Likert-type scale ranging from 0 (not at all) to 4 (extremely), the total score being calculated as the average score of the two questions.
Time Frame
Baseline to 12 weeks
Title
GCSQ Score, 5 Minutes Post-dose
Description
Daily diary record. Change in average values from run-in to the full treatment period.
The GCSQ consisted of two questions that required the patient to rate shortness of breath and feelings of chest tightness. The patients recorded their response on a five-point Likert-type scale ranging from 0 (not at all) to 4 (extremely), the total score being calculated as the average score of the two questions.
Time Frame
Baseline to 12 weeks
Title
GCSQ Score, 15 Minutes Post-dose
Description
Daily diary record. Change in average values from run-in to the full treatment period.
The GCSQ consisted of two questions that required the patient to rate shortness of breath and feelings of chest tightness. The patients recorded their response on a five-point Likert-type scale ranging from 0 (not at all) to 4 (extremely), the total score being calculated as the average score of the two questions.
Time Frame
Baseline to 12 weeks
Title
Capacity of Day Living in the Morning (CDLM) Score
Description
Daily diary record. Change in average values from run-in to the full treatment period.
The CDLM questionnaire is as a questionnaire to report on patient's ability to carry out each of six different morning activities (score ranging from 0 "not performed" to 1"performed") and rank the difficulty of performing each of those activities (score ranging from 0 "so difficult that the activity could not be carried out by the patient on their own" to 5 "activity was not at all difficult to carry out". Total score for each morning activity range from 0-6. Total score for whole CDLM questionnaire range from 0-36.
Time Frame
Baseline to 12 weeks
Title
Use of Rescue Medication, Night
Description
Daily diary record - Night, after evening measurement till morning. Change in average values from run-in to the full treatment period
Time Frame
Baseline to 12 weeks
Title
Use of Rescue Medication, Morning
Description
Daily diary record - Morning, after morning measurement till midday. Change in average values from run-in to the full treatment period
Time Frame
Baseline to 12 weeks
Title
Use of Rescue Medication, Day
Description
Daily diary record - Day, after morning measurement till evening. Change in average values from run-in to the full treatment period
Time Frame
Baseline to 12 weeks
Title
Use of Rescue Medication, Total
Description
Daily diary record - Total, 24 hours, during the night, and during the day. Change in average values from run-in to the full treatment period
Time Frame
Baseline to 12 weeks
Title
COPD Symptoms, Breathing Score
Description
Daily diary record. Change in average values from run-in to the full treatment period. Symptom scale 0 - 4 (0) None (1) Mild (2) Moderate (3) Marked (4) Severe
Time Frame
Baseline to 12 weeks
Title
COPD Symptoms, Sleeping Score
Description
Daily diary record. Change in average values from run-in to the full treatment period. Symptom scale 0 - 4 (0) None (1) Mild (2) Moderate (3) Marked (4) Severe
Time Frame
Baseline to 12 weeks
Title
COPD Symptoms, Chest Score
Description
Daily diary record. Change in average values from run-in to the full treatment period. Symptom scale 0 - 4 (0) None (1) Mild (2) Moderate (3) Marked (4) Severe
Time Frame
Baseline to 12 weeks
Title
COPD Symptoms, Cough Score
Description
Daily diary record. Change in average values from run-in to the full treatment period. Symptom scale 0 - 4 (0) None (1) Mild (2) Moderate (3) Marked (4) Severe
Time Frame
Baseline to 12 weeks
Title
Severe COPD Exacerbations
Description
Patients with worsening of COPD leading to treatment with systemic steroids (oral or parenteral), emergency room treatment or hospitalisation
Time Frame
12 weeks
Title
Serum High-sensitivity C-reactive Protein (hsCRP)
Description
Ratio of treatment period mean to run-in value
Time Frame
Baseline to 12 weeks
Title
Serum Interleukin 6 (IL-6)
Description
Ratio of treatment period mean to run-in value
Time Frame
Baseline to 12 weeks
Title
Serum Interleukin 8 (IL-8)
Description
Ratio of treatment period mean to run-in value
Time Frame
Baseline to 12 weeks
Title
Serum Monocyte Chemoattractant Protein-1 (MCP-1)
Description
Ratio of treatment period mean to run-in value
Time Frame
Baseline to 12 weeks
Title
Serum Soluble Tumor Necrosis Factor-alpha (sTNF-alpha)
Description
Ratio of treatment period mean to run-in value
Time Frame
Baseline to 12 weeks
Title
Serum Tumor Necrosis Factor-alpha (TNF-alpha)
Description
Ratio of treatment period mean to run-in value
Time Frame
Baseline to 12 weeks
Title
Serum Vascular Cell Adhesion Molecule-1 (VCAM-1)
Description
Ratio of treatment period mean to run-in value
Time Frame
Baseline to 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
>=40 years of age, diagnosed COPD with symptoms >=2 years, pre-bronchodilatory FEV1 <=50% of PN
Exclusion Criteria:
Current respiratory tract disorder other than COPD, history of asthma or rhinitis, significant or unstable cardiovascular disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomas Andersson, MD
Organizational Affiliation
AstraZeneca R&D Lund
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Tobias Welte, MD
Organizational Affiliation
Hannover Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Concord
State/Province
New South Wales
Country
Australia
Facility Name
Research Site
City
Sydney
State/Province
New South Wales
Country
Australia
Facility Name
Research Site
City
Auchenflower
State/Province
Queensland
Country
Australia
Facility Name
Research Site
City
Carina Heights
State/Province
Queensland
Country
Australia
Facility Name
Research Site
City
North Mackay
State/Province
Queensland
Country
Australia
Facility Name
Research Site
City
Adelaide
State/Province
South Australia
Country
Australia
Facility Name
Research Site
City
Daw Park
State/Province
South Australia
Country
Australia
Facility Name
Research Site
City
Clayton
State/Province
Victoria
Country
Australia
Facility Name
Research Site
City
Malvern
State/Province
Victoria
Country
Australia
Facility Name
Research Site
City
Nedlands
State/Province
Western Australia
Country
Australia
Facility Name
Research Site
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
Research Site
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Research Site
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
Research Site
City
St. John's
State/Province
Newfoundland and Labrador
Country
Canada
Facility Name
Research Site
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
Research Site
City
Mississauga
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
La Malbaie
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Trois-rivires
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Saskatoon
State/Province
Saskatchewan
Country
Canada
Facility Name
Research Site
City
Quebec
Country
Canada
Facility Name
Research Site
City
Chamalieres
Country
France
Facility Name
Research Site
City
Creil
Country
France
Facility Name
Research Site
City
Ferolles Attilly
Country
France
Facility Name
Research Site
City
Grasse
Country
France
Facility Name
Research Site
City
Lille
Country
France
Facility Name
Research Site
City
Marseille Cedex 06
Country
France
Facility Name
Research Site
City
Metz
Country
France
Facility Name
Research Site
City
Montpellier
Country
France
Facility Name
Research Site
City
Perpignan
Country
France
Facility Name
Research Site
City
Poitiers Cedex
Country
France
Facility Name
Research Site
City
Selestat
Country
France
Facility Name
Research Site
City
St Laurent Du Var
Country
France
Facility Name
Research Site
City
Strasbourg Cedex
Country
France
Facility Name
Research Site
City
Toulouse Cedex 9
Country
France
Facility Name
Research Site
City
Berlin
Country
Germany
Facility Name
Research Site
City
Gelsenkirchen
Country
Germany
Facility Name
Research Site
City
Hagen
Country
Germany
Facility Name
Research Site
City
Hannover
Country
Germany
Facility Name
Research Site
City
Kassel
Country
Germany
Facility Name
Research Site
City
Koblenz
Country
Germany
Facility Name
Research Site
City
Leipzig
Country
Germany
Facility Name
Research Site
City
Marburg
Country
Germany
Facility Name
Research Site
City
Potsdam
Country
Germany
Facility Name
Research Site
City
Aszod
Country
Hungary
Facility Name
Research Site
City
Baja
Country
Hungary
Facility Name
Research Site
City
Balassagyarmat
Country
Hungary
Facility Name
Research Site
City
Budapest
Country
Hungary
Facility Name
Research Site
City
Cegled
Country
Hungary
Facility Name
Research Site
City
Debrecen
Country
Hungary
Facility Name
Research Site
City
Fuzesabony
Country
Hungary
Facility Name
Research Site
City
Jaszbereny
Country
Hungary
Facility Name
Research Site
City
Komlo
Country
Hungary
Facility Name
Research Site
City
Nyiregyhaza
Country
Hungary
Facility Name
Research Site
City
Torokbalint
Country
Hungary
Facility Name
Research Site
City
Vásárosnamény
Country
Hungary
Facility Name
Research Site
City
Bydgoszcz
Country
Poland
Facility Name
Research Site
City
Chrzanów
Country
Poland
Facility Name
Research Site
City
Ilawa
Country
Poland
Facility Name
Research Site
City
Krakow
Country
Poland
Facility Name
Research Site
City
Lomza
Country
Poland
Facility Name
Research Site
City
Piekary Slaskie
Country
Poland
Facility Name
Research Site
City
Tarnow
Country
Poland
Facility Name
Research Site
City
Turek
Country
Poland
Facility Name
Research Site
City
Zawadzkie
Country
Poland
Facility Name
Research Site
City
Kosice
Country
Slovakia
Facility Name
Research Site
City
Liptovsky Hradok
Country
Slovakia
Facility Name
Research Site
City
Lucenec
Country
Slovakia
Facility Name
Research Site
City
Nove Mesto Nad Vahom
Country
Slovakia
Facility Name
Research Site
City
Nove Zamky
Country
Slovakia
Facility Name
Research Site
City
Piestany
Country
Slovakia
Facility Name
Research Site
City
Poprad
Country
Slovakia
Facility Name
Research Site
City
Povazska Bystrica
Country
Slovakia
Facility Name
Research Site
City
Presov
Country
Slovakia
Facility Name
Research Site
City
Prievidza
Country
Slovakia
Facility Name
Research Site
City
Revuca
Country
Slovakia
Facility Name
Research Site
City
Trnava
Country
Slovakia
Facility Name
Research Site
City
Zilina
Country
Slovakia
Facility Name
Research Site
City
Barcelona
State/Province
Cataluna
Country
Spain
Facility Name
Research Site
City
Reus (tarragona)
State/Province
Cataluna
Country
Spain
Facility Name
Research Site
City
Madrid
State/Province
Comunidad de Madrid
Country
Spain
Facility Name
Research Site
City
Requena (valencia)
State/Province
Comunidad Valenciana
Country
Spain
Facility Name
Research Site
City
Valencia
State/Province
Comunidad Valenciana
Country
Spain
Facility Name
Research Site
City
Pontevedra
State/Province
Galicia
Country
Spain
Facility Name
Research Site
City
Lindesberg
State/Province
Orebro Lan
Country
Sweden
Facility Name
Research Site
City
Atvidaberg
Country
Sweden
Facility Name
Research Site
City
Hollviken
Country
Sweden
Facility Name
Research Site
City
Limhamn
Country
Sweden
Facility Name
Research Site
City
Lund
Country
Sweden
Facility Name
Research Site
City
Malmo
Country
Sweden
Facility Name
Research Site
City
Motala
Country
Sweden
Facility Name
Research Site
City
Stockholm
Country
Sweden
Facility Name
Research Site
City
Uppsala
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
23856511
Citation
Nielsen R, Kankaanranta H, Bjermer L, Lange P, Arnetorp S, Hedegaard M, Stenling A, Mittmann N. Cost effectiveness of adding budesonide/formoterol to tiotropium in COPD in four Nordic countries. Respir Med. 2013 Nov;107(11):1709-21. doi: 10.1016/j.rmed.2013.06.007. Epub 2013 Jul 13.
Results Reference
derived
PubMed Identifier
21504240
Citation
Mittmann N, Hernandez P, Mellstrom C, Brannman L, Welte T. Cost effectiveness of budesonide/formoterol added to tiotropium bromide versus placebo added to tiotropium bromide in patients with chronic obstructive pulmonary disease: Australian, Canadian and Swedish healthcare perspectives. Pharmacoeconomics. 2011 May;29(5):403-14. doi: 10.2165/11590380-000000000-00000.
Results Reference
derived
PubMed Identifier
19897551
Citation
Partridge MR, Miravitlles M, Stahl E, Karlsson N, Svensson K, Welte T. Development and validation of the Capacity of Daily Living during the Morning questionnaire and the Global Chest Symptoms Questionnaire in COPD. Eur Respir J. 2010 Jul;36(1):96-104. doi: 10.1183/09031936.00123709. Epub 2009 Nov 6.
Results Reference
derived
PubMed Identifier
19644045
Citation
Welte T, Miravitlles M, Hernandez P, Eriksson G, Peterson S, Polanowski T, Kessler R. Efficacy and tolerability of budesonide/formoterol added to tiotropium in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2009 Oct 15;180(8):741-50. doi: 10.1164/rccm.200904-0492OC. Epub 2009 Jul 30.
Results Reference
derived
Learn more about this trial
Evaluation of Efficacy and Safety of Symbicort® as an add-on Treatment to Spiriva® in Patients With Severe COPD.
We'll reach out to this number within 24 hrs