A Comparison of SYMBICORT® pMDI With Formoterol Turbuhaler® in Subjects With COPD

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Drug: Budesonide/formoterol (SYMBICORT) pMDI
* Drug: Formoterol Turbuhaler


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A current clinical diagnosis of COPD with COPD symptoms for more than 2 years Current smoker or smoking history of 10 or more pack years (1 pack year = 20 cigarettes smoked per day for one year) A history of at least 1 COPD exacerbations requiring a course of steroids and/or antibiotics within 1-12 months before the first visit Exclusion Criteria: A history of asthma at or after 18 years of age A history of allergic rhinitis at or after 18 years of age Subjects taking oral steroids Any significant disease or disorder that may jeopardize a subject's safety

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Budesonide/formoterol (SYMBICORT) pMDI|nan|
|Drug: Formoterol Turbuhaler|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 months | 
| Rate of Exacerbations Per Subject-year | Rate of exacerbations per subject-year | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD