Evaluation of Efficacy and Safety of Symbicort® as an add-on Treatment to Spiriva® in Patients With Severe COPD.
- Conditions
- Chronic Obstructive Pulmonary Disease, COPD
- Interventions
- Registration Number
- NCT00496470
- Lead Sponsor
- AstraZeneca
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 660
- >=40 years of age, diagnosed COPD with symptoms >=2 years, pre-bronchodilatory FEV1 <=50% of PN
- Current respiratory tract disorder other than COPD, history of asthma or rhinitis, significant or unstable cardiovascular disorder
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Symbicort+TIO Symbicort (budesonide/formoterol turbuhaler 320/9ug) Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily Spiriva® + Placebo Turbuhaler Spiriva (tiotropium bromide 18ug) Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
- Primary Outcome Measures
Name Time Method Forced Expiratory Volume in 1 Second (FEV1) Pre-dose Baseline to 12 weeks 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
Name Time Method Forced Expiratory Volume in 1 Second (FEV1) 5 Min Post-dose Baseline to 12 weeks 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 Baseline to 12 weeks 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 Baseline to 12 weeks 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 Baseline to 12 weeks 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 Baseline to 12 weeks 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 Baseline to 12 weeks 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 Baseline to 12 weeks 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 Baseline and 12 weeks 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 Baseline to 12 weeks Daily diary record. Change in average values from run-in to the full treatment period
Evening Peak Expiratory Flow (PEF) Pre-dose Baseline to 12 weeks Daily diary record. Change in average values from run-in to the full treatment period
Morning Peak Expiratory Flow (PEF) 5 Min Post-dose Baseline to 12 weeks Daily diary record. Change in average values from run-in to the full treatment period
Morning Peak Expiratory Flow (PEF) 15 Min Post-dose Baseline to 12 weeks Daily diary record. Change in average values from run-in to the full treatment period
Morning Diary FEV1 Pre-dose Baseline to 12 weeks Daily diary record. Change in average values from run-in to the full treatment period
Evening Diary FEV1, Pre-dose Baseline to 12 weeks Daily diary record. Change in average values from run-in to the full treatment period
Morning Diary FEV1, 5 Minutes Post-dose Baseline to 12 weeks Daily diary record. Change in average values from run-in to the full treatment period
Morning Diary FEV1, 15 Minutes Post-dose Baseline to 12 weeks Daily diary record. Change in average values from run-in to the full treatment period
Global Chest Symptoms Questionnaire (GCSQ) Score, Pre-dose Baseline to 12 weeks 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 Baseline to 12 weeks 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 Baseline to 12 weeks 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 Baseline to 12 weeks 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 Baseline to 12 weeks 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 Baseline to 12 weeks 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 Baseline to 12 weeks 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 Baseline to 12 weeks 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 Baseline to 12 weeks 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 Baseline to 12 weeks 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 Baseline to 12 weeks 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 Baseline to 12 weeks 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 12 weeks 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) Baseline to 12 weeks Ratio of treatment period mean to run-in value
Serum Interleukin 6 (IL-6) Baseline to 12 weeks Ratio of treatment period mean to run-in value
Serum Interleukin 8 (IL-8) Baseline to 12 weeks Ratio of treatment period mean to run-in value
Serum Monocyte Chemoattractant Protein-1 (MCP-1) Baseline to 12 weeks Ratio of treatment period mean to run-in value
Serum Soluble Tumor Necrosis Factor-alpha (sTNF-alpha) Baseline to 12 weeks Ratio of treatment period mean to run-in value
Serum Tumor Necrosis Factor-alpha (TNF-alpha) Baseline to 12 weeks Ratio of treatment period mean to run-in value
Serum Vascular Cell Adhesion Molecule-1 (VCAM-1) Baseline to 12 weeks Ratio of treatment period mean to run-in value
Trial Locations
- Locations (1)
Research Site
🇸🇪Uppsala, Sweden