Inhaled long-acting bronchodilators with or without inhaled glucocorticosteroids for preventing hospitalizations and death in elderly patients with chronic obstructive pulmonary disease.
- Conditions
- chronic obstructive pulmonary disease (COPD)MedDRA version: 21.1Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 100000004855Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2018-000739-28-IT
- Lead Sponsor
- AZIENDA OSPEDALIERO UNIVERSITARIA DI FERRARA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1032
1.Participant must be older than 60 years of age, at the time of signing the informed consent.
2.Recently (within 6 months) discharged from hospital with a diagnosis of acute exacerbation of COPD (usually coded as DRG 087 or DRG 088).
3.Participants with a clinical diagnosis of COPD (i.e. previous diagnosis of COPD and/or treatment with short acting bronchodilators (SABD), LABD or LABD+ICS)
4.Spirometry confirmed diagnosis of COPD, post-bronchodilator (30 minutes after 400 µg salbutamol) FEV1/FVC ratio <0.7. The diagnostic spirometry test can have been performed up to three years prior to randomization, or if never performed before, should be performed not earlier than 4 weeks since last exacerbation
5.Smokers or ex-smokers with a smoking history of >10 pack years (a pack year is defined as 20 cigarettes smoked every day for a year)
6.Clinical diagnosis documented in the patient’s medical records of one or more major chronic cardiac disease (heart failure, ischemic heart disease or atrial fibrillation).
7.Currently receiving at least one of the specified treatments (either alone or in combination, see Appendix 10.5) for heart failure, ischemic heart disease or atrial fibrillation.
8.Participant must be willing and able to perform pulmonary function tests
9.Male or female. Contraception is not considered necessary in this cohort of elderly (> 60 years) patients receiving treatment with commercially available licensed products.
10.Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
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 105
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 927
1.Patients with a primary discharge diagnosis of DRG 087 or DRG 088 but clearly judged by the clinical investigator to be due to other causes, i.e. patients presenting to the hospital with symptoms of AECOPD but due mainly to other conditions (pulmonary embolism, pneumonia, pneumothorax, anemia, acute kidney failure, decompensated heart failure, acute ischemic heart disease, new onset atrial fibrillation, stroke, etc.)
2.Patients who required invasive mechanical ventilation during hospitalization
3.Patients with Asthma as primary and principal diagnosis
4.Patients with severe cardiovascular (CV) disease who in the opinion of the investigator are unlikely to survive the 15 month study period
5.Patients considered unable to comply with the study procedures and follow-up in the opinion of the investigator (eg, evidence of alcohol or drug abuse, psychiatric disorder, physical disability, social or geographical obstacles)
6.Patients in whom spirometry is contraindicated (eg, hemoptysis, detached retina, active tuberculosis, last trimester of pregnancy)
7.Patients with other mechanical or overt causes of respiratory symptoms, particularly dyspnea (such as pneumothorax, chest wall trauma, lung fibrosis, lung cancer, anemia, severe obesity (BMI >40) or cachexia (BMI <18))
8.Patients with any major disease which in the opinion of the investigator would prevent study participation, such as dementia, end-stage disease, cachexia, chronically bedridden patient and life expectancy <15 months.
9.Participation in any other interventional study within the last 3 months or concurrent participation in an observational clinical study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method