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Phase 1

• Conditions: Chronic obstructive pulmonary disease (COPD); MedDRA version: 21.0Level: LLTClassification code 10070975Term: Chronic obstructive bronchopneumopathySystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2015-000982-30-IT
• Lead Sponsor: FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-08
• Last Update Posted: 26 July 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 168

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.
11. Ability to perform reproducible spirometry.
12. Patient is an ex smoker and has stopped smoking for at least 6 months.
13. Ability of patient to provide informed consent

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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 118

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.
11. Upper respiratory infections or exacerbations in the previous 4 weeks.

Study & Design

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