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

Phase 3

Completed

• Conditions: Chronic Obstructive Pulmonary Disease

• Registration Number: NCT00419744
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-01-05
• Study First Submitted QC: 2007-01-05
• Study First Posted: 2007-01-09
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Status Verified: 2010-08
• Results First Submitted: 2010-08-18
• Results First Submitted QC: 2010-08-18
• Last Update Submitted: 2010-08-18
• Results First Posted: 2010-09-16
• Last Update Posted: 2010-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1200

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Rate of Exacerbations Per Subject-year	12 months	Rate of exacerbations per subject-year
Total Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Patient-treatment Year	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.

Secondary Outcome Measures

Name	Time	Method
Pre-dose Forced Expiratory Volume in 1 Second (FEV1)	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)	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	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	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	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	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.

Trial Locations

Locations (1)

Research Site; 🇻🇪 Distrito Capital, Caracas, Venezuela