E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Pazienti affetti da grave broncopneumopatia cronica ostruttiva |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10053420 |
|
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 |
Controllo dlla spesa/paziente attraverso una maggiore aderenza alla terapia da parte del paziente affetto da insufficienza respiratoria cronica in OTLT; il controllo e' ottenuto con un monitoraggio quotidiano del consumo di ossigeno e dei valori di ossimetria utilizzando il monitoraggio domiciliare telemetrico. |
|
E.2.2 | Secondary objectives of the trial |
Riduzione dei giorni di ospedalizzazione/anno
Riduzione numero riacutizzazioni/anno
Miglioramento della qualita' della vita valutata con un specifico questionario
Riduzione delle spese mediche dirette |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Pazienti con diagnosi accertata BPCO
Pazienti in OTLT da almeno 2 anni
Pazienti in OTLT per almeno 18 ore/die
Pazienti in OTLT con almeno 1 ricovero/anno nei due anni precedenti l'arruolamento per riacutizzazioni di BPCO. |
|
E.4 | Principal exclusion criteria |
Asma bronchiale cronica
Bronchiectasie clinicamente documentate
Ossigenoterapia somministrata per neoplasia polmonare o cardiopatia cronica
Ossigenoterapia somministrta al bisogno o per durata <18 ore |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Controllo dlla spesa/paziente attraverso una maggiore aderenza alla terapia da parte del paziente affetto da insufficienza respiratoria cronica in OTLT; il controllo e' ottenuto con un monitoraggio quotidiano del consumo di ossigeno e dei valori di ossimetria utilizzando il monitoraggio domiciliare telemetrico. |
|
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 | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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 | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | Information not present in EudraCT |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | No |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
protocollo di controllo ambulatoria |
|
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |