We want to investigate whether a three day treatment with orally administered systemic corticosteroids is non-inferior to a five day treatment in acute exacerbation of COPD managed in an outpatient setting and if total glucocorticoid exposure can be reduced by shorter therapy.

Phase 1

• Conditions: acute exacerbation of COPD; acute exacerbation (defined solely by clinical parameters accordingto the Anthonisen criteria, meaning =2 of the following: change of baseline dyspnea, change of cough, change ofsputum quantity or purulence) of their previously diagnosed COPD (irreversible obstruction withFEV1/FVC<70%); MedDRA version: 21.1Level: LLTClassification code 10010953Term: COPD exacerbationSystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2017-004872-76-AT
• Lead Sponsor: Medizinische Universtitätsklinik, Kantonsspital Baselland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-28
• Last Update Posted: 29 June 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 470

Inclusion Criteria

- Informed Consent as documented by signature
- Age =40 years
- History of =10 pack-years of smoking (past or present smokers)
- Airway obstruction, defined as FEV1/FVC=70%
- Current acute exacerbation of COPD by clinical criteria, defined by the presence of at least two of the
following:
o Change of baseline dyspnea
o Change of cough
o Change of sputum quantity or purulence
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 314
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 156

Exclusion Criteria

- Asthma/COPD overlap syndrome with a predominant Asthma component
- Initial necessity of hospitalization
- Women who are pregnant or breast feeding
- Premenopausal women with insufficient contraception and anamnestic risk for pregnancy
- Severe coexisting disease with life expectancy <6 months
- Diagnosis of tuberculosis
- Known severe immunosuppression or immunosuppression after solid organ or stem cell transplantation
- Inability to follow study procedures, e.g. due to language problems, psychological disorders, dementia,
etc. of the participant
- Participation in another study involving an investigational drug
- Previous enrolment into the current study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified