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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00496470
Registration number
NCT00496470
Ethics application status
Date submitted
3/07/2007
Date registered
4/07/2007
Date last updated
9/11/2012
Titles & IDs
Public title
Evaluation of Efficacy and Safety of Symbicort® as an add-on Treatment to Spiriva® in Patients With Severe COPD.
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Scientific 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
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Secondary ID [1]
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Eudract no:2006-006796-21
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Secondary ID [2]
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D5892C00015
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease, COPD
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Condition category
Condition code
Respiratory
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0
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Chronic obstructive pulmonary disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Symbicort (budesonide/formoterol turbuhaler 320/9ug)
Treatment: Drugs - Spiriva (tiotropium bromide 18ug)
Active Comparator: Symbicort+TIO - Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
Active Comparator: Spiriva® + Placebo Turbuhaler - Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
Treatment: Drugs: Symbicort (budesonide/formoterol turbuhaler 320/9ug)
Symbicort (budesonide/formoterol turbuhaler 320/9ug)
Treatment: Drugs: Spiriva (tiotropium bromide 18ug)
Spiriva (tiotropium bromide 18ug)
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Forced Expiratory Volume in 1 Second (FEV1) Pre-dose
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Assessment method [1]
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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)
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Timepoint [1]
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Baseline to 12 weeks
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Secondary outcome [1]
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Forced Expiratory Volume in 1 Second (FEV1) 5 Min Post-dose
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Assessment method [1]
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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)
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Timepoint [1]
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Baseline to 12 weeks
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Secondary outcome [2]
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Forced Expiratory Volume in 1 Second (FEV1) 60 Min Post-dose
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Assessment method [2]
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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)
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Timepoint [2]
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Baseline to 12 weeks
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Secondary outcome [3]
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Forced Vital Capacity (FVC) Pre-dose
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Assessment method [3]
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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)
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Timepoint [3]
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Baseline to 12 weeks
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Secondary outcome [4]
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Forced Vital Capacity (FVC) 5 Minutes Post-dose
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Assessment method [4]
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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)
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Timepoint [4]
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Baseline to 12 weeks
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Secondary outcome [5]
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Forced Vital Capacity (FVC) 60 Minutes Post-dose
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Assessment method [5]
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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
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Timepoint [5]
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Baseline to 12 weeks
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Secondary outcome [6]
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Inspiratory Capacity (IC) Pre-dose
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Assessment method [6]
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0
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)
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Timepoint [6]
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Baseline to 12 weeks
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Secondary outcome [7]
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0
Inspiratory Capacity (IC) 60 Minutes Post-dose
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Assessment method [7]
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0
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)
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Timepoint [7]
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Baseline to 12 weeks
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Secondary outcome [8]
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St George's Respiratory Questionnaire for COPD Patients (SGRQ-C) Score
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Assessment method [8]
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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.
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Timepoint [8]
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0
Baseline and 12 weeks
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Secondary outcome [9]
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0
Morning Peak Expiratory Flow (PEF) Pre-dose
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Assessment method [9]
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0
Daily diary record. Change in average values from run-in to the full treatment period
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Timepoint [9]
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Baseline to 12 weeks
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Secondary outcome [10]
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0
Evening Peak Expiratory Flow (PEF) Pre-dose
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Assessment method [10]
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0
Daily diary record. Change in average values from run-in to the full treatment period
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Timepoint [10]
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0
Baseline to 12 weeks
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Secondary outcome [11]
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0
Morning Peak Expiratory Flow (PEF) 5 Min Post-dose
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Assessment method [11]
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0
Daily diary record. Change in average values from run-in to the full treatment period
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Timepoint [11]
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0
Baseline to 12 weeks
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Secondary outcome [12]
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0
Morning Peak Expiratory Flow (PEF) 15 Min Post-dose
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Assessment method [12]
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0
Daily diary record. Change in average values from run-in to the full treatment period
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Timepoint [12]
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Baseline to 12 weeks
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Secondary outcome [13]
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0
Morning Diary FEV1 Pre-dose
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Assessment method [13]
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0
Daily diary record. Change in average values from run-in to the full treatment period
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Timepoint [13]
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Baseline to 12 weeks
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Secondary outcome [14]
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0
Evening Diary FEV1, Pre-dose
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Assessment method [14]
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0
Daily diary record. Change in average values from run-in to the full treatment period
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Timepoint [14]
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Baseline to 12 weeks
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Secondary outcome [15]
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0
Morning Diary FEV1, 5 Minutes Post-dose
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Assessment method [15]
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0
Daily diary record. Change in average values from run-in to the full treatment period
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Timepoint [15]
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0
Baseline to 12 weeks
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Secondary outcome [16]
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0
Morning Diary FEV1, 15 Minutes Post-dose
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Assessment method [16]
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0
Daily diary record. Change in average values from run-in to the full treatment period
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Timepoint [16]
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0
Baseline to 12 weeks
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Secondary outcome [17]
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0
Global Chest Symptoms Questionnaire (GCSQ) Score, Pre-dose
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Assessment method [17]
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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.
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Timepoint [17]
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0
Baseline to 12 weeks
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Secondary outcome [18]
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0
GCSQ Score, 5 Minutes Post-dose
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Assessment method [18]
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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.
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Timepoint [18]
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Baseline to 12 weeks
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Secondary outcome [19]
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GCSQ Score, 15 Minutes Post-dose
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Assessment method [19]
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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.
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Timepoint [19]
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Baseline to 12 weeks
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Secondary outcome [20]
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Capacity of Day Living in the Morning (CDLM) Score
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Assessment method [20]
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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.
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Timepoint [20]
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Baseline to 12 weeks
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Secondary outcome [21]
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Use of Rescue Medication, Night
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Assessment method [21]
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Daily diary record - Night, after evening measurement till morning. Change in average values from run-in to the full treatment period
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Timepoint [21]
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Baseline to 12 weeks
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Secondary outcome [22]
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0
Use of Rescue Medication, Morning
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Assessment method [22]
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0
Daily diary record - Morning, after morning measurement till midday. Change in average values from run-in to the full treatment period
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Timepoint [22]
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0
Baseline to 12 weeks
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Secondary outcome [23]
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0
Use of Rescue Medication, Day
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Assessment method [23]
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Daily diary record - Day, after morning measurement till evening. Change in average values from run-in to the full treatment period
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Timepoint [23]
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Baseline to 12 weeks
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Secondary outcome [24]
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Use of Rescue Medication, Total
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Assessment method [24]
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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
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Timepoint [24]
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0
Baseline to 12 weeks
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Secondary outcome [25]
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0
COPD Symptoms, Breathing Score
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Assessment method [25]
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0
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
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Timepoint [25]
0
0
Baseline to 12 weeks
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Secondary outcome [26]
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0
COPD Symptoms, Sleeping Score
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Assessment method [26]
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0
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
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Timepoint [26]
0
0
Baseline to 12 weeks
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Secondary outcome [27]
0
0
COPD Symptoms, Chest Score
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Assessment method [27]
0
0
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
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Timepoint [27]
0
0
Baseline to 12 weeks
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Secondary outcome [28]
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0
COPD Symptoms, Cough Score
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Assessment method [28]
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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
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Timepoint [28]
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0
Baseline to 12 weeks
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Secondary outcome [29]
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0
Severe COPD Exacerbations
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Assessment method [29]
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0
Patients with worsening of COPD leading to treatment with systemic steroids (oral or parenteral), emergency room treatment or hospitalisation
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Timepoint [29]
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0
12 weeks
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Secondary outcome [30]
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0
Serum High-sensitivity C-reactive Protein (hsCRP)
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Assessment method [30]
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0
Ratio of treatment period mean to run-in value
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Timepoint [30]
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Baseline to 12 weeks
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Secondary outcome [31]
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0
Serum Interleukin 6 (IL-6)
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Assessment method [31]
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0
Ratio of treatment period mean to run-in value
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Timepoint [31]
0
0
Baseline to 12 weeks
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Secondary outcome [32]
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0
Serum Interleukin 8 (IL-8)
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Assessment method [32]
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0
Ratio of treatment period mean to run-in value
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Timepoint [32]
0
0
Baseline to 12 weeks
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Secondary outcome [33]
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0
Serum Monocyte Chemoattractant Protein-1 (MCP-1)
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Assessment method [33]
0
0
Ratio of treatment period mean to run-in value
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Timepoint [33]
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0
Baseline to 12 weeks
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Secondary outcome [34]
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Serum Soluble Tumor Necrosis Factor-alpha (sTNF-alpha)
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Assessment method [34]
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Ratio of treatment period mean to run-in value
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Timepoint [34]
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0
Baseline to 12 weeks
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Secondary outcome [35]
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Serum Tumor Necrosis Factor-alpha (TNF-alpha)
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Assessment method [35]
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Ratio of treatment period mean to run-in value
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Timepoint [35]
0
0
Baseline to 12 weeks
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Secondary outcome [36]
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Serum Vascular Cell Adhesion Molecule-1 (VCAM-1)
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Assessment method [36]
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Ratio of treatment period mean to run-in value
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Timepoint [36]
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Baseline to 12 weeks
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Eligibility
Key inclusion criteria
- >=40 years of age, diagnosed COPD with symptoms >=2 years, pre-bronchodilatory FEV1
<=50% of PN
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Minimum age
40
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Current respiratory tract disorder other than COPD, history of asthma or rhinitis,
significant or unstable cardiovascular disorder
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/06/2008
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Sample size
Target
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Accrual to date
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Final
660
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Research Site - Concord
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Recruitment hospital [2]
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Research Site - Sydney
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Recruitment hospital [3]
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Research Site - Auchenflower
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Recruitment hospital [4]
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Research Site - Carina Heights
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Recruitment hospital [5]
0
0
Research Site - North Mackay
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Recruitment hospital [6]
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Research Site - Adelaide
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Recruitment hospital [7]
0
0
Research Site - Daw Park
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Recruitment hospital [8]
0
0
Research Site - Clayton
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Recruitment hospital [9]
0
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Research Site - Malvern
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Recruitment hospital [10]
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Research Site - Nedlands
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Recruitment postcode(s) [1]
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0
- Concord
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Recruitment postcode(s) [2]
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0
- Sydney
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Recruitment postcode(s) [3]
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- Auchenflower
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Recruitment postcode(s) [4]
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- Carina Heights
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Recruitment postcode(s) [5]
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0
- North Mackay
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Recruitment postcode(s) [6]
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0
- Adelaide
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Recruitment postcode(s) [7]
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0
- Daw Park
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Recruitment postcode(s) [8]
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0
- Clayton
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Recruitment postcode(s) [9]
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0
- Malvern
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Recruitment postcode(s) [10]
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- Nedlands
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Recruitment outside Australia
Country [1]
0
0
Canada
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State/province [1]
0
0
Alberta
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Country [2]
0
0
Canada
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State/province [2]
0
0
British Columbia
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Country [3]
0
0
Canada
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State/province [3]
0
0
Manitoba
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Country [4]
0
0
Canada
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State/province [4]
0
0
Newfoundland and Labrador
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Country [5]
0
0
Canada
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State/province [5]
0
0
Nova Scotia
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Country [6]
0
0
Canada
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State/province [6]
0
0
Ontario
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Country [7]
0
0
Canada
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State/province [7]
0
0
Quebec
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Country [8]
0
0
Canada
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State/province [8]
0
0
Saskatchewan
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Country [9]
0
0
France
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State/province [9]
0
0
Chamalieres
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Country [10]
0
0
France
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State/province [10]
0
0
Creil
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Country [11]
0
0
France
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State/province [11]
0
0
Ferolles Attilly
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Country [12]
0
0
France
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State/province [12]
0
0
Grasse
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Country [13]
0
0
France
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State/province [13]
0
0
Lille
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Country [14]
0
0
France
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State/province [14]
0
0
Marseille Cedex 06
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Country [15]
0
0
France
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State/province [15]
0
0
Metz
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Country [16]
0
0
France
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State/province [16]
0
0
Montpellier
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Country [17]
0
0
France
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State/province [17]
0
0
Perpignan
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Country [18]
0
0
France
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State/province [18]
0
0
Poitiers Cedex
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Country [19]
0
0
France
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State/province [19]
0
0
Selestat
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Country [20]
0
0
France
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State/province [20]
0
0
St Laurent Du Var
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Country [21]
0
0
France
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State/province [21]
0
0
Strasbourg Cedex
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Country [22]
0
0
France
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State/province [22]
0
0
Toulouse Cedex 9
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Country [23]
0
0
Germany
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State/province [23]
0
0
Berlin
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Country [24]
0
0
Germany
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State/province [24]
0
0
Gelsenkirchen
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Country [25]
0
0
Germany
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State/province [25]
0
0
Hagen
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Country [26]
0
0
Germany
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State/province [26]
0
0
Hannover
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Country [27]
0
0
Germany
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State/province [27]
0
0
Kassel
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Country [28]
0
0
Germany
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State/province [28]
0
0
Koblenz
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Country [29]
0
0
Germany
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State/province [29]
0
0
Leipzig
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Country [30]
0
0
Germany
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State/province [30]
0
0
Marburg
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Country [31]
0
0
Germany
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State/province [31]
0
0
Potsdam
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Country [32]
0
0
Hungary
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State/province [32]
0
0
Aszod
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Country [33]
0
0
Hungary
Query!
State/province [33]
0
0
Baja
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Country [34]
0
0
Hungary
Query!
State/province [34]
0
0
Balassagyarmat
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Country [35]
0
0
Hungary
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State/province [35]
0
0
Budapest
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Country [36]
0
0
Hungary
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State/province [36]
0
0
Cegled
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Country [37]
0
0
Hungary
Query!
State/province [37]
0
0
Debrecen
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Country [38]
0
0
Hungary
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State/province [38]
0
0
Fuzesabony
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Country [39]
0
0
Hungary
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State/province [39]
0
0
Jaszbereny
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Country [40]
0
0
Hungary
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State/province [40]
0
0
Komlo
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Country [41]
0
0
Hungary
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State/province [41]
0
0
Nyiregyhaza
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Country [42]
0
0
Hungary
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State/province [42]
0
0
Torokbalint
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Country [43]
0
0
Hungary
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State/province [43]
0
0
Vásárosnamény
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Country [44]
0
0
Poland
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State/province [44]
0
0
Bydgoszcz
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Country [45]
0
0
Poland
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State/province [45]
0
0
Chrzanów
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Country [46]
0
0
Poland
Query!
State/province [46]
0
0
Ilawa
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Country [47]
0
0
Poland
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State/province [47]
0
0
Krakow
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Country [48]
0
0
Poland
Query!
State/province [48]
0
0
Lomza
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Country [49]
0
0
Poland
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State/province [49]
0
0
Piekary Slaskie
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Country [50]
0
0
Poland
Query!
State/province [50]
0
0
Tarnow
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Country [51]
0
0
Poland
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Turek
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Poland
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Zawadzkie
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Kosice
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Slovakia
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Liptovsky Hradok
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Lucenec
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Slovakia
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Nove Mesto Nad Vahom
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Nove Zamky
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Piestany
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Poprad
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Slovakia
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Povazska Bystrica
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Slovakia
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Presov
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Prievidza
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Revuca
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Slovakia
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Trnava
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Zilina
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Spain
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Cataluna
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Spain
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Comunidad de Madrid
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Spain
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Comunidad Valenciana
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Spain
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Galicia
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Sweden
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Orebro Lan
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Atvidaberg
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Hollviken
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Sweden
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Limhamn
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Sweden
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Lund
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Malmo
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Sweden
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Motala
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Stockholm
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Sweden
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Uppsala
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Funding & Sponsors
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Commercial sector/Industry
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Name
AstraZeneca
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00496470
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Public notes
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Contacts
Principal investigator
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Tomas Andersson, MD
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Address
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AstraZeneca R&D Lund
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00496470
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