We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of Symbicort® Turbuhaler® (Budesonide/Formoterol) in Chronic Obstructive Pulmonary Disease (COPD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00837629
First Posted: February 5, 2009
Last Update Posted: January 24, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  Purpose
This non-interventional study is to analyse the therapeutic effectiveness in patients with severe COPD following a generally accepted 12-week treatment period with Symbicort Turbuhaler, which could anyhow be shortened or extended at physician's discretion.

Condition
Chronic Obstructive Pulmonary Disease

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: An Open-label Non-interventional Evaluation of Efficacy of Symbicort® Forte Turbuhaler 320/9 µg (Budesonide / Formoterol) and Symbicort® Turbuhaler® 160/4,5 µg (Budesonide / Formoterol)in Functional Status Improvement of Patients With Chronic Obstructive Pulmonary Disease (COPD)

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Reduction in overall Clinical COPD Questionnaire (CCQ) score [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • Patient satisfaction [ Time Frame: 12 weeks ]
  • Physicians' global clinical impression of the treatment [ Time Frame: 12 weeks ]
  • Evaluation of smoking habits [ Time Frame: 12 weeks ]

Enrollment: 743
Study Start Date: February 2007
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients (outpatient or hospitalised) in whom Symbicort Turbuhaler is indicated according to the current Summary of product characteristics (SPC)
Criteria

Inclusion Criteria:

  • non pregnant female
  • COPD with persistent symptoms in spite of regular bronchodilator therapy
  • Naive or fixed combination treated patients including patients already on Symbicort Turbuhaler

Exclusion Criteria:

  • Hypersensitivity to budesonide, formoterol or inhaled lactose
  Contacts and Locations
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): NCT00837629


Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Matjaz Flezar, MD Golnik Hospital
  More Information

Responsible Party: Meta Jeras, Mr Ph, Regulatory and Medical Affairs Manager, AstraZeneca
ClinicalTrials.gov Identifier: NCT00837629     History of Changes
Other Study ID Numbers: NIS-RSI-SYM-2006/1
First Submitted: February 4, 2009
First Posted: February 5, 2009
Last Update Posted: January 24, 2011
Last Verified: January 2011

Keywords provided by AstraZeneca:
chronic obstructive pulmonary disease
COPD
Symbicort Turbuhaler

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Formoterol Fumarate
Budesonide
Budesonide, Formoterol Fumarate Drug Combination
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists