Evaluation of Efficacy and Safety of Symbicort® as an add-on Treatment to Spiriva® in Patients With Severe COPD.
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| ClinicalTrials.gov Identifier: NCT00496470 |
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Recruitment Status :
Completed
First Posted : July 4, 2007
Results First Posted : November 9, 2012
Last Update Posted : November 9, 2012
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Obstructive Pulmonary Disease, COPD | Drug: Symbicort (budesonide/formoterol turbuhaler 320/9ug) Drug: Spiriva (tiotropium bromide 18ug) | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 660 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 Start Date : | May 2007 |
| Actual Primary Completion Date : | June 2008 |
| Actual Study Completion Date : | June 2008 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Symbicort+TIO
Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
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Drug: Symbicort (budesonide/formoterol turbuhaler 320/9ug)
Symbicort (budesonide/formoterol turbuhaler 320/9ug) |
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Active Comparator: Spiriva® + Placebo Turbuhaler
Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
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Drug: Spiriva (tiotropium bromide 18ug)
Spiriva (tiotropium bromide 18ug) |
- Forced Expiratory Volume in 1 Second (FEV1) Pre-dose [ Time Frame: 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)
- Forced Expiratory Volume in 1 Second (FEV1) 5 Min Post-dose [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline to 12 weeks ]Daily diary record. Change in average values from run-in to the full treatment period
- Morning Diary FEV1 Pre-dose [ Time Frame: Baseline to 12 weeks ]Daily diary record. Change in average values from run-in to the full treatment period
- Evening Diary FEV1, Pre-dose [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: Baseline to 12 weeks ]Ratio of treatment period mean to run-in value
- Serum Interleukin 6 (IL-6) [ Time Frame: Baseline to 12 weeks ]Ratio of treatment period mean to run-in value
- Serum Interleukin 8 (IL-8) [ Time Frame: Baseline to 12 weeks ]Ratio of treatment period mean to run-in value
- Serum Monocyte Chemoattractant Protein-1 (MCP-1) [ Time Frame: Baseline to 12 weeks ]Ratio of treatment period mean to run-in value
- Serum Soluble Tumor Necrosis Factor-alpha (sTNF-alpha) [ Time Frame: Baseline to 12 weeks ]Ratio of treatment period mean to run-in value
- Serum Tumor Necrosis Factor-alpha (TNF-alpha) [ Time Frame: Baseline to 12 weeks ]Ratio of treatment period mean to run-in value
- Serum Vascular Cell Adhesion Molecule-1 (VCAM-1) [ Time Frame: Baseline to 12 weeks ]Ratio of treatment period mean to run-in value
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00496470
Show 93 study locations
| Study Director: | Tomas Andersson, MD | AstraZeneca R&D Lund | |
| Principal Investigator: | Tobias Welte, MD | Hannover Medical School |
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00496470 |
| Other Study ID Numbers: |
D5892C00015 Eudract no:2006-006796-21 |
| First Posted: | July 4, 2007 Key Record Dates |
| Results First Posted: | November 9, 2012 |
| Last Update Posted: | November 9, 2012 |
| Last Verified: | October 2012 |
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Chronic Obstructive Pulmonary Disease, COPD |
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Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Budesonide Bromides Formoterol Fumarate Tiotropium Bromide Budesonide, Formoterol Fumarate Drug Combination Anti-Inflammatory Agents Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents |
Respiratory System Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Parasympatholytics Cholinergic Antagonists Cholinergic Agents Anticonvulsants |