Budesonide / Formoterol in Treatment of Exacerbations of COPD - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00239278

Purpose

The purpose of this study is to determine whether the budesonide+formoterol combination is effective in the treatment of exacerbations of COPD with a main emphasis on investigating the effects on inflammation and a secondary emphasis on clinical efficacy

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease (COPD)	Drug: budesonide/formoterol, 2x 200/6 microgram. 4 times daily Drug: prednisolone, 30 mg once daily and placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Effects of High Dose Inhaled Budesonide+ Formoterol Versus Placebo and Oral Prednisolone on Biomarkers of Airway Inflammation in the Treatment of Exacerbations in Non-Hospitalised Patients With Mild to Moderate COPD.

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Prednisolone Prednisolone acetate Depo-medrol Formoterol fumarate Budesonide Arformoterol Formoterol Medrol veriderm Methylprednisolone Arformoterol Tartrate Prednisolone sodium phosphate Prednisolone Sodium Succinate Methylprednisolone Sodium Succinate Methylprednisolone hemisuccinate 6-Methylprednisolone

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Eosinophils in induced sputum (as % of Total Cell Count), change from the start of the exacerbation to the end of 14 days treatment

Secondary Outcome Measures:

Inflammatory markers in induced sputum, blood/serum and urine
Lung function tests at clinic
Diary cards for PEF and symptoms
Patient Related outcomes
Questioning for Adverse Events and in blood: routine tests and cortisol

Estimated Enrollment:	120
Study Start Date:	January 2001
Study Completion Date:	January 2005

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

smoking-induced COPD according to ATS criteria
FEV1 <85% of predicted at enrolment and <70% of predicted but > 0.7 Liter at Exacerbation
FEV1/IVC ratio <88% of predicted for men and <89% for women

Exclusion Criteria:

history of asthma
known hypersensitivity to the study drugs
serious concomitant diseases
pregnancy or lactating
abnormal Chest X-ray or blood gasses

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00239278

Locations

Netherlands
Research Site
Groningen, Netherlands

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Netherlands Medical Director, MD

AstraZeneca

More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Bathoorn E, Liesker JJ, Postma DS, Boorsma M, Bondesson E, Koëter GH, Kauffman HF, van Oosterhout AJ, Kerstjens HA. Anti-inflammatory effects of combined budesonide/formoterol in COPD exacerbations. COPD. 2008 Oct;5(5):282-90.

Bathoorn E, Liesker J, Postma D, Koeter G, van Oosterhout AJ, Kerstjens HA. Safety of sputum induction during exacerbations of COPD. Chest. 2007 Feb;131(2):432-8.

Study ID Numbers:	SD-039-0698
Study First Received:	October 13, 2005
Last Updated:	March 27, 2009
ClinicalTrials.gov Identifier:	NCT00239278 History of Changes
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study placed in the following topic categories:

Anti-Inflammatory Agents
Neurotransmitter Agents
Symbicort
Adrenergic Agents
Methylprednisolone
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Prednisolone acetate
Hormones
Neuroprotective Agents
Adrenergic Agonists
Lung Diseases, Obstructive
Respiratory Tract Diseases

Formoterol
Methylprednisolone Hemisuccinate
Adrenergic beta-Agonists
Antineoplastic Agents, Hormonal
Budesonide
Methylprednisolone acetate
Anti-Asthmatic Agents
Glucocorticoids
Inflammation
Lung Diseases
Prednisolone
Peripheral Nervous System Agents
Bronchodilator Agents
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Symbicort
Methylprednisolone
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Prednisolone acetate
Neuroprotective Agents
Hormones
Adrenergic Agonists

Lung Diseases, Obstructive
Respiratory Tract Diseases
Therapeutic Uses
Formoterol
Methylprednisolone Hemisuccinate
Adrenergic beta-Agonists
Antineoplastic Agents, Hormonal
Gastrointestinal Agents
Budesonide
Anti-Asthmatic Agents
Methylprednisolone acetate
Protective Agents
Glucocorticoids
Pharmacologic Actions
Autonomic Agents

ClinicalTrials.gov processed this record on September 11, 2009