A Comparison of SYMBICORT® pMDI With Formoterol Turbuhaler® in Subjects With COPD
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|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|
|Actual Primary Completion Date :||August 2009|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00419744
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|Study Director:||Christer Hultquist, MD||AstraZeneca|