Budesonide / Formoterol in Treatment of Exacerbations of COPD

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.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00239278

Enrollment

120

Registered

2005-10-17

Start date

2001-01-31

Completion date

2005-01-31

Last updated

2011-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Brief summary

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

Interventions

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

DRUGprednisolone, 30 mg once daily and placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026