E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic obstructive pulmonary disease, heart failure |
|
E.1.1.1 | Medical condition in easily understood language |
Pulmonary disease, Cardiac disease |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
|
E.2.2 | Secondary objectives of the trial |
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. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
|
E.4 | Principal 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. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Reduction of hospitalizations due to COPD exacerbations |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
every 3 months for at least 12 months |
|
E.5.2 | 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. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
every 3 months for at least 12 months |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 7 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |