The purpose of this study is to determine if SYMBICORT® delivered via a pressurized metered-dose inhaler, referred to as a pMDI, is effective in preventing COPD exacerbations.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,200
Total Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Patient-treatment Year
Number of COPD-related exacerbations per patient-treatment year. COPD-related exacerbation was defined as worsening COPD that required a course of oral steriods for treatment and/or hospitalization.
Time frame: 12 months
Rate of Exacerbations Per Subject-year
Rate of exacerbations per subject-year
Time frame: 12 months
Pre-dose Forced Expiratory Volume in 1 Second (FEV1)
Change in pre-dose FEV1 from baseline to the average of the randomized treatment period, as calculated by averaging treatment period FEV1 values and subtracting the pre-dose value.
Time frame: 12 months
Morning Peak Expiratory Flow (PEF)
Change in morning PEF from baseline to the average of the randomized treatment period, as calculated by averaging treatment period PEF values and subtracting the baseline morning PEF value.
Time frame: 12 months
Evening PEF
Change in evening PEF from baseline to the average of the randomized treatment period, as calculated by averaging treatment period PEF values and subtracting the baseline evening PEF value.
Time frame: 12 months
Dyspnea Symptom Scores
Change from baseline of Dyspnea symptoms evaluated using the breathlessness diary, a 5-point Likert-type scale, ranging from 0 to 4 with higher scores indicating a more severe manifestation of the Dyspnea symptom. Change from baseline was calculated by averaging treatment period Dyspnea scores and subtracting the baseline Dyspnea scores.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Research Site
Jasper, Alabama, United States
Research Site
Mobile, Alabama, United States
Research Site
Tucson, Arizona, United States
Research Site
Fort Smith, Arkansas, United States
Research Site
Little Rock, Arkansas, United States
Research Site
Anaheim, California, United States
Research Site
Foothill Ranch, California, United States
Research Site
Fullerton, California, United States
Research Site
Long Beach, California, United States
Research Site
Los Angeles, California, United States
...and 130 more locations
Time frame: 12 months
Use of Rescue Medication
Change from baseline in the use of beta-2 agonists, as calculated by averaging treatment period inhalations per day and subtracting the baseline number of inhalations per day.
Time frame: 12 months
St. George's Respiratory Questionnaire (SGRQ) Score
Change from baseline in the SGRQ overall score, as calculated by averaging treatment period SGRQ scores and subtracting the baseline SGRQ scores. The SGRQ contains 3 domains: Symptoms (distress due to respiratory symptoms, 8 questions), Activity (disturbance of physical activity, 16 questions), and Impacts (overall impact on daily life and well-being, 26 questions). Lower scores are associated with less severe symptoms.
Time frame: 12 months