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OpenTrials
Completed

NCT Number: NCT00239278

Budesonide / Formoterol in Treatment of Exacerbations of COPD

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

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site

Groningen, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

budesonide/formoterol, 2x 200/6 microgram. 4 times daily

Drug

Other names: Symbicort

prednisolone, 30 mg once daily and placebo

Drug

Primary outcomes

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

Secondary outcomes

  1. Inflammatory markers in induced sputum, blood/serum and urine

  2. Lung function tests at clinic

  3. Diary cards for PEF and symptoms

  4. Patient Related outcomes

  5. Questioning for Adverse Events and in blood: routine tests and cortisol

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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.

Important dates

Study start
2001
Study completion
2005
First posted
Oct 17, 2005
Registry last updated
Jan 24, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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