Phase 3
Completed N=260
A Safety and Efficacy Study of Symbicort Turbuhaler Compared With Standard Chronic Obstructive Pulmonary Disease (COPD) Treatment in Japan
Source: ClinicalTrials.gov NCT01070784 ↗Enrolled (actual)
260
Serious AEs
22.7%
Results posted
Dec 2013
Primary outcomePrimary: Clinical Laboratory Test: Haematology -Erythrocytes — -7.6; -0.1 *10000/μl
Summary
The purpose of this study is to evaluate the safety and efficacy of Symbicort Turbuhaler compared to standard COPD treatment during one year in Japanese patients with COPD.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Laboratory Test: Haematology -Erythrocytes |
-7.6; -0.1 | — |
| PRIMARY Clinical Laboratory Test: Haematology -Haemoglobin |
-0.22; -0.05 | — |
| PRIMARY Clinical Laboratory Test: Haematology -Leucocytes |
160.8; -184.8 | — |
| PRIMARY Clinical Laboratory Test: Haematology -Platelet Count |
0.86; 0.12 | — |
| PRIMARY Clinical Laboratory Test: Haematology -Eosinophils |
-0.52; 0.14 | — |
| PRIMARY Clinical Laboratory Test: Haematology -Basophils |
-0.06; -0.06 | — |
| PRIMARY Clinical Laboratory Test: Haematology -Lymphocytes |
-5.47; -3.24 | — |
| PRIMARY Clinical Laboratory Test: Haematology -Monocytes |
0.29; -0.03 | — |
| PRIMARY Clinical Laboratory Test: Haematology -Neutrophils |
5.78; 2.92 | — |
| PRIMARY Clinical Laboratory Test: Clinical Chemistry- S-Alanine Aminotransferase |
0.5; 1.5 | — |
| PRIMARY Clinical Laboratory Test: Clinical Chemistry- S-Aspartate Aminotransferase |
0.0; 1.1 | — |
| PRIMARY Clinical Laboratory Test: Clinical Chemistry- S-Alkaline Phosphatase (ALP) |
1.3; 8.2 | — |
| PRIMARY Clinical Laboratory Test: Clinical Chemistry- S-Creatinine |
0.003; -0.017 | — |
| PRIMARY Clinical Laboratory Test: Clinical Chemistry- S-Total Bilirubin |
0.05; 0.00 | — |
| PRIMARY Clinical Laboratory Test: Clinical Chemistry- S-Sodium |
-0.8; -0.6 | — |
| PRIMARY Clinical Laboratory Test: Clinical Chemistry- S-Potassium |
-0.11; -0.08 | — |
| PRIMARY Clinical Laboratory Test: Clinical Chemistry- S- Calcium |
0.02; 0.01 | — |
| PRIMARY Clinical Laboratory Test: Clinical Chemistry- S-Albumin |
0.03; 0.04 | — |
| PRIMARY Clinical Laboratory Test: Clinical Chemistry- S-Protein, Total |
0.01; 0.02 | — |
| PRIMARY Clinical Laboratory Test: Clinical Chemistry- S-C-Reactive Protein |
0.243; 0.224 | — |
| PRIMARY Clinical Laboratory Test: Clinical Chemistry- S-Urea Nitrogen |
-0.51; -0.64 | — |
| PRIMARY Vital Signs- Sitting Systolic Blood Pressure(SBP) |
-0.8; -3.2 | — |
| PRIMARY Vital Signs- Sitting Diastolic Blood Pressure(DBP) |
-0.8; -1.3 | — |
| PRIMARY Vital Signs- Pulse Rate |
3.2; 3.1 | — |
| PRIMARY ECG Variables - Heart Rate |
3.6; 3.4 | — |
| PRIMARY ECG Variables - QT Interval |
-4.5; -7.5 | — |
| PRIMARY ECG Variables - QTcB Interval |
3.6; 2.4 | — |
| PRIMARY ECG Variables - QTcF Interval |
0.7; -1.1 | — |
| PRIMARY ECG Variables - RR Interval |
-30.9; -43.8 | — |
| SECONDARY Chronic Obstructive Pulmonary Disease (COPD) symptoms_Night-time Awakening |
0.0; -0.1 | — |
| SECONDARY Chronic Obstructive Pulmonary Disease (COPD) symptoms_Breathlessness |
-0.2; -0.1 | — |
| SECONDARY Chronic Obstructive Pulmonary Disease (COPD) symptoms_cough |
-0.2; -0.2 | — |
| SECONDARY Forced Expiratory Volume in 1 Second (FEV1) Measured With the Spirometer at the Clinic |
104.25; 98.43 | — |
| SECONDARY Forced Vital Capacity (FVC) Measured With the Spirometer at the Clinic |
102.51; 100.04 | — |
| SECONDARY Time to First COPD Exacerbation |
20.0; 31.5 | — |
| SECONDARY Number of COPD Exacerbations Over the Study Treatment Period |
41; 105 | — |
| SECONDARY Rescue Medication Use |
-0.2; 0.0 | — |
| SECONDARY Health Related Quality of Life (HRQL) Based on the St. George's Respiratory Questionnaire (SGRQ) |
-2.03; -0.42 | — |
| SECONDARY Morning Peak Expiratory Flow (PEF) Measured at Home |
5.9; 5.7 | — |
| SECONDARY Evening Peak Expiratory Flow (PEF) Measured at Home |
2.7; 5.2 | — |
| SECONDARY Morning FEV1 Measured by the Subjects at Home |
0.017; 0.006 | — |
| SECONDARY Evening FEV1 Measured by the Subjects at Home |
0.006; 0.010 | — |
Eligibility Criteria
Inclusion Criteria
- A current clinical diagnosis of COPD according to the guidelines (GOLD, JPS)
- Documented COPD symptoms for more than 2 years
- Pre-bronchodilator FEV1≦50% of predicted normal value, and post-bronchodilator FEV1/FVC<70%
Exclusion Criteria
- History and/or current clinical diagnosis of asthma and atopic diseases such as allergic rhinitis
- Subjects with significant or unstable ischemic heart disease, arrhythmia, cardiomyopathy, heart failure, uncontrolled hypertension as defined by the investigator, or any other relevant cardiovascular disorder as judged by the investigator
- COPD exacerbation during the run-in period or within 4 weeks prior to registration, requiring hospitalization and/or treatment with systemic steroids.
Data sourced from ClinicalTrials.gov (NCT01070784). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.