A Comparison of SYMBICORT® pMDI With Formoterol Turbuhaler® in Subjects With COPD
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00419744
First received: January 5, 2007
Last updated: August 18, 2010
Last verified: August 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Obstructive Pulmonary Disease |
Drug: Budesonide/formoterol (SYMBICORT) pMDI Drug: Formoterol Turbuhaler |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Total Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Patient-treatment Year [ Time Frame: 12 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Rate of exacerbations per subject-year
Secondary Outcome Measures:
- Pre-dose Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: 12 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
| Enrollment: | 1200 |
| Study Start Date: | January 2007 |
| Study Completion Date: | August 2009 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00419744
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Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | Christer Hultquist, MD | AstraZeneca |
More Information
No publications provided by AstraZeneca
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00419744 History of Changes |
| Other Study ID Numbers: | D589CC00003 |
| Study First Received: | January 5, 2007 |
| Results First Received: | August 18, 2010 |
| Last Updated: | August 18, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by AstraZeneca:
|
COPD |
Additional relevant MeSH terms:
|
Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases Budesonide Formoterol Symbicort Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions |
Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Inflammatory Agents Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013