EUCTR2015-000982-30-IT
Active, not recruiting
Phase 1
Personalized pharmacological treatment of chronic obstructive pulmonary disease based on phenotyping: interventional study - na
FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE0 sites168 target enrollmentJune 8, 2021
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
- Enrollment
- 168
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Male or female, \>60 and \<85 years of age.
- •2\. COPD (stage II\-IV) based on GOLD guidelines with a FEV1/FVC \< 70% and FEV1 \<60% of the predicted value (6\).
- •3\. Reversibility to 400 µg equivalent of salbutamol \<200 ml and \<12% predicted value FEV1(6\).
- •4\. At least one COPD exacerbation in the previous year.
- •5\. No acute exacerbations or upper respiratory tract infection in the previous 4 weeks.
- •6\. No history of systemic disease or other pulmonary disease.
- •7\. No ICS or systemic glucocorticoids in the previous 4 weeks.
- •8\. No history of asthma or atopic disease.
- •9\. Allowed treatment for COPD at visit 1: short\-acting beta2\-agonists alone as needed and LAMA and/or LABA on regular basis. If on different LAMA and/or LABA, at visit 1, patients will be shifted to study bronchodilators as described above.
- •10\. Patients able to complete the study.
Exclusion Criteria
- •1\. Inability to provide informed consent
- •2\. Patient is hospitalized
- •3\. Major surgical procedure in the previous four weeks
- •4\. Participation in a clinical trial in the previous four weeks
- •5\. Patient is current smoker
- •6\. No COPD exacerbation in the previous year.
- •7\. Patient has been hospitalized for COPD in the previous two months.
- •8\. Other respiratory diseases in addition to COPD
- •9\. Glaucoma
- •10\. Any illness that could be immediately life threatening.
Outcomes
Primary Outcomes
Not specified
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