Efficacy and Safety Study of Symbicort® Turbuhaler® Versus Oxis® Turbuhaler® in Chronic Obstructive Pulmonary Disease (COPD) Patients
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Drug: Budesonide/formoterol (Symbicort Turbuhaler)
- Registration Number
- NCT01069289
- Lead Sponsor
- AstraZeneca
- Brief Summary
The primary purpose of the study is to investigate if Symbicort is more effective than Oxis in increasing forced expiratory volume in one second (FEV1), measured at the clinics, in patients with COPD.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1293
- A current clinical diagnosis of Chronic Obstructive Pulmonary Disease
- Documented Chronic Obstructive Pulmonary Disease symptoms for more than 2 years
- A smoking history of at least 10 pack years
- History and/or current clinical diagnosis of asthma
- History and/or current clinical diagnosis of atopic diseases such as allergic rhinitis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Budesonide/formoterol (Symbicort Turbuhaler) Symbicort Turbuhaler 160/4.5 microgram, 2 inhalations twice daily 2 Formoterol (Oxis Turbuhaler) Oxis Turbuhaler 4.5 microgram, 2 inhalations twice daily
- Primary Outcome Measures
Name Time Method Pre-dose Forced Expiratory Volume in One Second (FEV1) Before randomization, 0, 4, 8 and 12 weeks after randomization The ratio, expressed as percentage, of the geometric mean of available data for Weeks 0, 4, 8 and 12 to the baseline for each treatment group
- Secondary Outcome Measures
Name Time Method 1 Hour Post Dose Forced Expiratory Volume in One Second (FEV1) Before randomization, 0, 4, 8 and 12 weeks after randomization The ratio, expressed as percentage, of the geometric mean of available data for Weeks 0, 4, 8 and 12 to the baseline for each treatment group
Pre-dose Forced Vital Capacity (FVC) Before randomization, 0, 4, 8 and 12 weeks after randomization The ratio, expressed as percentage, of the geometric mean of available data for Weeks 0, 4, 8 and 12 to the baseline for each treatment group
1 Hour Post-dose Forced Vital Capacity (FVC) Before randomization, 0, 4, 8 and 12 weeks after randomization The ratio, expressed as percentage, of the geometric mean of available data for Weeks 0, 4, 8 and 12 to the baseline for each treatment group
Percentage of Participants With Exacerbations Daily during 12-week randomization treatment A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as worsening in COPD symptoms requiring treatment with either a course of systemic steroid or hospitalisation. The percentage of participants who had experienced COPD exacerbation at the end of the study for each treatment group.
Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Daily during 12-week randomization treatment A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as worsening in COPD symptoms requiring treatment with either a course of systemic steroid or hospitalisation. Number of COPD exacerbation during 12-week randomization treatment
Morning Peak Expiratory Flow(PEF) Daily during run-in period and daily during 12-week randomization treatment The change from Run-in period average to Treatment period average for each treatment group
Evening Peak Expiratory Flow (PEF) Daily during run-in period and daily during 12-week randomization treatment The change from Run-in period average to Treatment period average for each treatment group
Total Number of Day With Exacerbation Daily during 12-week randomization treatment Total number of days with COPD exacerbation for each treatment group
Morning Forced Expiratory Volume in One Second (FEV1) Daily during run-in period and daily during 12-week randomization treatment The change from Run-in period average to Treatment period average for each treatment group
Evening Forced Expiratory Volume in One Second (FEV1) Daily during run-in period and daily during 12-week randomization treatment The change from Run-in period average to Treatment period average for each treatment group
Night-time Awakening Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms Daily during run-in period and daily during 12-week randomization treatment Scored 0 to 1 (0 = no awakening and 1 = awakening). The change from Run-in period average to Treatment period average for each treatment group
Breathlessness Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms Daily during run-in period and daily during 12-week randomization treatment There are 5 alternatives (scored 0 to 4, with 4 being the most severe condition). The change from Run-in period average to Treatment period average for each treatment group
Cough Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms Daily during run-in period and daily during 12-week randomization treatment There are 5 alternatives (scored 0 to 4, with 4 being the most severe condition). The change from Run-in period average to Treatment period average for each treatment group
Total Chronic Obstructive Pulmonary Disease (COPD) Symptom Score Daily during run-in period and daily during 12-week randomization treatment The Total COPD Symptom score is the sum of the measures night-time awakening, breathlessness and cough, ranges from 0 to 12 with 12 being the most severe. The change from Run-in period average to Treatment period average for each treatment group.
Use of Rescue Medication Daily during run-in period and daily during 12-week randomization treatment The change from Run-in period average to Treatment period average for each treatment group.
St George's Respiratory Questionnaire (SGRQ) Total Score Daily during run-in period and daily during 12-week randomization treatment The change from Run-in period average to Treatment period average for each treatment group. The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life).
Trial Locations
- Locations (2)
Research Site
🇻🇳Ho Chi Minh, Vietnam
Researche Site
🇵🇭San Fernando, Pampanga, Philippines