Efficacy and Safety Study of Symbicort® Turbuhaler® Versus Oxis® Turbuhaler® in Chronic Obstructive Pulmonary Disease (COPD) Patients

Study Overview
=================
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.

Official Title
-----------------
A Phase III, 12-week, Double-blind, Randomised, Parallel-group, Active-controlled, Multinational, Efficacy and Safety Study of Symbicort® Turbuhaler® 160/4.5 μg 2 Inhalations Twice Daily (Bid) Compared to Oxis® Turbuhaler® 4.5 μg 2 Inhalations Twice Daily (Bid) in Patients With Chronic Obstructive Pulmonary Disease

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Drug: Budesonide/formoterol (Symbicort Turbuhaler)
* Drug: Formoterol (Oxis Turbuhaler)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: History and/or current clinical diagnosis of asthma History and/or current clinical diagnosis of atopic diseases such as allergic rhinitis

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Symbicort Turbuhaler 160/4.5 microgram, 2 inhalations twice daily | Drug: Budesonide/formoterol (Symbicort Turbuhaler)<br>* 2x160/4.5 microgram, inhalation, twice daily, 12 weeks<br>* Other names: Symbicort Turbuhaler;|
| Active Comparator: 2<br>Oxis Turbuhaler 4.5 microgram, 2 inhalations twice daily | Drug: Formoterol (Oxis Turbuhaler)<br>* 2 X 4.5 microgram, inhalation, twice daily, 12 weeks<br>* Other names: Oxis Turbuhaler;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-dose Forced Expiratory Volume in One Second (FEV1) | 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 | Before randomization, 0, 4, 8 and 12 weeks after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1 Hour Post Dose Forced Expiratory Volume in One Second (FEV1) | 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 | Before randomization, 0, 4, 8 and 12 weeks after randomization | 
| Pre-dose Forced Vital Capacity (FVC) | 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 | Before randomization, 0, 4, 8 and 12 weeks after randomization | 
| 1 Hour Post-dose Forced Vital Capacity (FVC) | 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 | Before randomization, 0, 4, 8 and 12 weeks after randomization | 
| Percentage of Participants With Exacerbations | 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. | Daily during 12-week randomization treatment | 
| Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation | 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 | Daily during 12-week randomization treatment | 
| Morning Peak Expiratory Flow(PEF) | The change from Run-in period average to Treatment period average for each treatment group | Daily during run-in period and daily during 12-week randomization treatment | 
| Evening Peak Expiratory Flow (PEF) | The change from Run-in period average to Treatment period average for each treatment group | Daily during run-in period and daily during 12-week randomization treatment | 
| Total Number of Day With Exacerbation | Total number of days with COPD exacerbation for each treatment group | Daily during 12-week randomization treatment | 
| Morning Forced Expiratory Volume in One Second (FEV1) | The change from Run-in period average to Treatment period average for each treatment group | Daily during run-in period and daily during 12-week randomization treatment | 
| Evening Forced Expiratory Volume in One Second (FEV1) | The change from Run-in period average to Treatment period average for each treatment group | Daily during run-in period and daily during 12-week randomization treatment | 
| Night-time Awakening Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms | 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 | Daily during run-in period and daily during 12-week randomization treatment | 
| Breathlessness Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms | 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 | Daily during run-in period and daily during 12-week randomization treatment | 
| Cough Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms | 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 | Daily during run-in period and daily during 12-week randomization treatment | 
| Total Chronic Obstructive Pulmonary Disease (COPD) Symptom Score | 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. | Daily during run-in period and daily during 12-week randomization treatment | 
| Use of Rescue Medication | The change from Run-in period average to Treatment period average for each treatment group. | Daily during run-in period and daily during 12-week randomization treatment | 
| St George's Respiratory Questionnaire (SGRQ) Total Score | 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). | Daily during run-in period and daily during 12-week randomization treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Symbicort, Oxis, Chronic Obstructive Pulmonary Disease, COPD, Efficacy