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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00837629
First received: February 4, 2009
Last updated: January 21, 2011
Last verified: January 2011
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Reduction in overall Clinical COPD Questionnaire (CCQ) score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient satisfaction [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Physicians' global clinical impression of the treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Evaluation of smoking habits [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00837629

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

No publications provided

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
Study First Received: February 4, 2009
Last Updated: January 21, 2011
Health Authority: Slovenia: Agency for Medicinal Products - Ministry of Health

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

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