Chronic obstructive pulmonary disease, heart failure
Conditions
Interventions
Product Name: Bisoprololo
Pharmaceutical Form: Capsule
CAS Number: 66722-45-0
Other descriptive name: BISOPROLOL HEMIFUMARATE
Concentration unit: mg/g milligram(s)/gram
Concentration type: range
Conce
Sponsors
Università di Napoli Federico II
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age > 75 years 2. Diagnosis of HF according to AHA/ACC (J Am Coll Cardiol 2006;47:1503-1505) made at least 3 months previously. At enrollment, patients must be on stage B-C or NYHA II-III. 3. Diagnosis of COPD according to the ATS/ERS criteria (Eur Respir J. 2004 ;23:932-46), made at least 3 months previously, in GOLD stage II-III. All the enrolled patients must be clinically stable during the preceding 3 weeks and in standard therapeutic regimen, according to the guidelines for HF and COPD, before being randomized either to treatment or to placebo groups. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 823
Exclusion criteria
Exclusion criteria: 2. Inability to perform spirometry. 3. Any type of neoplasm. 4. Any non-neoplastic disease limiting life expectance to less than one year. 5. Cognitive or sensorial impairment preventing all the study planned evaluations 6. Critical social and enviromental status preventing an adequate drug compliance. 7. Contraindications to ß-blocker therapy 8. Previous evidence of adverse drug reactions to ß-blockers 9. Decompensated liver cirrhosis, renal failure (serum creatinine >3 mg/dl). 10. Decompensated diabetes. 11. Acute myocardial infarction and cerebrovascular events occurred in the last 3 months 12. Logistic issues preventing follow-up completion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of efficacy in elderly patients aged more than 75 years with concomitant diagnosis of HF and COPD, both clinically stable with standard therapy, of add-on of beta1-selective antagonist bisoprolol in term of incidence of COPD exacerbations requiring hospitalization.;Secondary Objective: Evaluation of the effects - neutral or favorable - of chronic treatment with bisoprolol on bronchobstructive indexes and on bronchodilating effects of rapidly acting ß2-agonists in elderly COPD patients.;Primary end point(s): Reduction of hospitalizations due to COPD exacerbations;Timepoint(s) of evaluation of this end point: every 3 months for at least 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Evaluation of the effects - neutral or favorable - of chronic treatment with bisoprolol on bronchobstructive indexes and on bronchodilating effects of rapidly acting ß2-agonists in elderly COPD patients.;Timepoint(s) of evaluation of this end point: every 3 months for at least 12 months | — |
Countries
Italy
Contacts
Public ContactDivision of Geriatrics
Università di Napoli Federico II
Outcome results
None listed