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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
This study has been completed.
First Received: September 13, 2005   Last Updated: March 26, 2009   History of Changes
Sponsor: AstraZeneca
Information provided by: AstraZeneca
ClinicalTrials.gov Identifier: NCT00206154
  Purpose

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 Intervention Phase
Chronic Obstructive Pulmonary Disease
 Drug: Budesonide/formoterol pMDI
Drug: Budesonide pMDI
Drug: Formoterol Turbuhaler
 Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)
Drug Information available for: Phenylpropanolamine Formoterol fumarate Budesonide Arformoterol Formoterol Triaminic Guaifenesin Symbicort Arformoterol Tartrate Phenylpropanolamine hydrochloride Naphazoline hydrochloride Naphazoline
U.S. FDA Resources

Further study details as provided by AstraZeneca:

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

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

Estimated Enrollment: 1500
Study Start Date: April 2005
Study Completion Date: December 2006
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00206154

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Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Symbicort Medical Science Director, MD AstraZeneca
  More Information

No publications provided

Study ID Numbers: D5899C00002, EurodraCT No: 2004-001183-41
Study First Received: September 13, 2005
Last Updated: March 26, 2009
ClinicalTrials.gov Identifier: NCT00206154     History of Changes
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic beta-Agonists
Symbicort
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Budesonide
Anti-Asthmatic Agents
Hormones
 Glucocorticoids
Adrenergic Agonists
Pharmacologic Actions
Lung Diseases, Obstructive
Respiratory Tract Diseases
Autonomic Agents
Therapeutic Uses
Lung Diseases
Formoterol
Peripheral Nervous System Agents
Bronchodilator Agents
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on November 27, 2009



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