A Comparison of SYMBICORT® pMDI With Formoterol Turbuhaler® in Subjects With COPD
|ClinicalTrials.gov Identifier: NCT00419744|
Recruitment Status : Completed
First Posted : January 9, 2007
Results First Posted : September 16, 2010
Last Update Posted : September 16, 2010
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease||Drug: Budesonide/formoterol (SYMBICORT) pMDI Drug: Formoterol Turbuhaler||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1200 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Phase IIIB, 12-Month, Double-blind, Double-dummy,Randomised, Parallel-group, Multicentre Exacerbation Study of SYMBICORT® pMDI 160/4.5 μg x 2 Actuations Twice-daily and 80/4.5 μg x 2 Actuations Twice-daily Compared to Formoterol Turbuhaler® 4.5 μg x 2 Inhalations Twice-daily in COPD Subjects|
|Study Start Date :||January 2007|
|Primary Completion Date :||August 2009|
|Study Completion Date :||August 2009|
- Total Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Patient-treatment Year [ Time Frame: 12 months ]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.
- Rate of Exacerbations Per Subject-year [ Time Frame: 12 months ]Rate of exacerbations per subject-year
- Pre-dose Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: 12 months ]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.
- Morning Peak Expiratory Flow (PEF) [ Time Frame: 12 months ]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.
- Evening PEF [ Time Frame: 12 months ]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.
- Dyspnea Symptom Scores [ Time Frame: 12 months ]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.
- Use of Rescue Medication [ Time Frame: 12 months ]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.
- St. George's Respiratory Questionnaire (SGRQ) Score [ Time Frame: 12 months ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00419744
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|Study Director:||Christer Hultquist, MD||AstraZeneca|