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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
Sponsor:
Information provided by:
AstraZeneca

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: Budesonide/formoterol (SYMBICORT) pMDI Drug: Formoterol Turbuhaler Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : January 2007
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. Rate of Exacerbations Per Subject-year [ Time Frame: 12 months ]
    Rate of exacerbations per subject-year


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.


Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Christer Hultquist, MD AstraZeneca
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00419744    
Other Study ID Numbers: D589CC00003
First Posted: January 9, 2007    Key Record Dates
Results First Posted: September 16, 2010
Last Update Posted: September 16, 2010
Last Verified: August 2010
Keywords provided by AstraZeneca:
COPD
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
Budesonide
Formoterol Fumarate
Budesonide, Formoterol Fumarate Drug Combination
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action