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

Sponsor:	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	Drug: budesonide/formoterol, 2x 200/6 microgram. 4 times daily Drug: prednisolone, 30 mg once daily and placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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:

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

Intervention Details:

Other Name: Symbicort

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 ClinicalTrials.gov Identifier (NCT Number):

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.

ClinicalTrials.gov Identifier:	NCT00239278 History of Changes
Other Study ID Numbers:	SD-039-0698, D5892C00698
Study First Received:	October 13, 2005
Last Updated:	January 21, 2011
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:

Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Budesonide
Prednisolone phosphate
Formoterol
Symbicort
Anti-Inflammatory Agents

Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on February 12, 2012