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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
660
Symbicort (budesonide/formoterol turbuhaler 320/9ug)
Spiriva (tiotropium bromide 18ug)
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)
Time frame: Baseline to 12 weeks
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)
Time frame: Baseline to 12 weeks
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)
Time frame: Baseline to 12 weeks
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)
Time frame: Baseline to 12 weeks
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)
Time frame: Baseline to 12 weeks
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
Time frame: Baseline to 12 weeks
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Research Site
Concord, New South Wales, Australia
Research Site
Sydney, New South Wales, Australia
Research Site
Auchenflower, Queensland, Australia
Research Site
Carina Heights, Queensland, Australia
Research Site
North Mackay, Queensland, Australia
Research Site
Adelaide, South Australia, Australia
Research Site
Daw Park, South Australia, Australia
Research Site
Clayton, Victoria, Australia
Research Site
Malvern, Victoria, Australia
Research Site
Nedlands, Western Australia, Australia
...and 83 more locations
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)
Time frame: Baseline to 12 weeks
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)
Time frame: Baseline to 12 weeks
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.
Time frame: Baseline and 12 weeks
Morning Peak Expiratory Flow (PEF) Pre-dose
Daily diary record. Change in average values from run-in to the full treatment period
Time frame: Baseline to 12 weeks
Evening Peak Expiratory Flow (PEF) Pre-dose
Daily diary record. Change in average values from run-in to the full treatment period
Time frame: Baseline to 12 weeks
Morning Peak Expiratory Flow (PEF) 5 Min Post-dose
Daily diary record. Change in average values from run-in to the full treatment period
Time frame: Baseline to 12 weeks
Morning Peak Expiratory Flow (PEF) 15 Min Post-dose
Daily diary record. Change in average values from run-in to the full treatment period
Time frame: Baseline to 12 weeks
Morning Diary FEV1 Pre-dose
Daily diary record. Change in average values from run-in to the full treatment period
Time frame: Baseline to 12 weeks
Evening Diary FEV1, Pre-dose
Daily diary record. Change in average values from run-in to the full treatment period
Time frame: Baseline to 12 weeks
Morning Diary FEV1, 5 Minutes Post-dose
Daily diary record. Change in average values from run-in to the full treatment period
Time frame: Baseline to 12 weeks
Morning Diary FEV1, 15 Minutes Post-dose
Daily diary record. Change in average values from run-in to the full treatment period
Time frame: Baseline to 12 weeks
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.
Time frame: Baseline to 12 weeks
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.
Time frame: Baseline to 12 weeks
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.
Time frame: Baseline to 12 weeks
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.
Time frame: Baseline to 12 weeks
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
Time frame: Baseline to 12 weeks
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
Time frame: Baseline to 12 weeks
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
Time frame: Baseline to 12 weeks
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
Time frame: Baseline to 12 weeks
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
Time frame: Baseline to 12 weeks
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
Time frame: Baseline to 12 weeks
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
Time frame: Baseline to 12 weeks
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
Time frame: Baseline to 12 weeks
Severe COPD Exacerbations
Patients with worsening of COPD leading to treatment with systemic steroids (oral or parenteral), emergency room treatment or hospitalisation
Time frame: 12 weeks
Serum High-sensitivity C-reactive Protein (hsCRP)
Ratio of treatment period mean to run-in value
Time frame: Baseline to 12 weeks
Serum Interleukin 6 (IL-6)
Ratio of treatment period mean to run-in value
Time frame: Baseline to 12 weeks
Serum Interleukin 8 (IL-8)
Ratio of treatment period mean to run-in value
Time frame: Baseline to 12 weeks
Serum Monocyte Chemoattractant Protein-1 (MCP-1)
Ratio of treatment period mean to run-in value
Time frame: Baseline to 12 weeks
Serum Soluble Tumor Necrosis Factor-alpha (sTNF-alpha)
Ratio of treatment period mean to run-in value
Time frame: Baseline to 12 weeks
Serum Tumor Necrosis Factor-alpha (TNF-alpha)
Ratio of treatment period mean to run-in value
Time frame: Baseline to 12 weeks
Serum Vascular Cell Adhesion Molecule-1 (VCAM-1)
Ratio of treatment period mean to run-in value
Time frame: Baseline to 12 weeks