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A Comparison of Symbicort® pMDI 2 x 160/4.5 μg Bid and Symbicort® pMDI 2 x 80/4.5 μg Bid With Formoterol Turbuhaler®, Budesonide pMDI, the Combination of Formoterol Turbuhaler® and Budesonide pMDI, and Placebo in COPD Patients

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ClinicalTrials.gov Identifier: NCT00206154
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : March 27, 2009
Sponsor:
Information provided by:
AstraZeneca

Study Description
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Brief Summary:
The purpose of this study is to compare a combination asthma drug (Symbicort) with its two components, budesonide and formoterol, taken individually or in combination, and with placebo in the long-term maintenance treatment of patients with chronic obstructive pulmonary disease (COPD)

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A 6-Month Double-Blind, Double-Dummy, Randomized, Parallel Group, Multicenter Efficacy & Safety Study of SYMBICORT® pMDI 2 x 160/4.5 µg & 80/4.5 µg Bid Compared to Formoterol TBH, Budesonide pMDI (& the Combination) & Placebo in COPD Patients
Study Start Date : April 2005
Actual Study Completion Date : December 2006

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Pre-dose and 1-hour post-dose FEV1 over the 6 months treatment period

Secondary Outcome Measures :
  1. Patient-reported outcome variables regarding disease status (incl. PEF), collected via questionnaires and diaries
  2. Health care utilization
  3. Pharmacokinetics (subgroup)
  4. Safety variables, including adverse events, vital signs, ECG, physical examination, hematology, and clinical chemistry.
  5. - all variables assessed over the 6 months treatment period

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 clinical diagnosis of COPD with symptoms for more than 2 years
  • Smoking history of 10 or more pack years
  • A history of at least one COPD exacerbation requiring a course of oral steroids and/or antibiotics within 1-12 months before first visit.

Exclusion Criteria:

  • A history of asthma
  • Patients taking oral steroids.
  • Any significant disease or disorder that may jeopardize the safety of the patient
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): NCT00206154


Locations
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Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: AstraZeneca Symbicort Medical Science Director, MD AstraZeneca
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00206154    
Other Study ID Numbers: D5899C00002
EurodraCT No: 2004-001183-41
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: March 27, 2009
Last Verified: March 2009
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
Budesonide
Formoterol Fumarate
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