| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Chronic Obstructive Pulmonary Disease (COPD) |
| Broncopneumopatia cronica ostruttiva (BPCO) |
|
| E.1.1.1 | Medical condition in easily understood language |
| COPD is a chronic condition of the lungs which causes people to suffer symptoms such as shortness of breath and coughing. |
| La BPCO è una condizione cronica dei polmoni che fa sì che le persone soffrano di sintomi come respiro corto e tosse. |
|
| E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 20.0 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10010952 |
| E.1.2 | Term | COPD |
| E.1.2 | System Organ Class | 100000004855 |
|
| 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 |
| Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 |
| Volume respiratorio forzato in 1 secondo (FEV1) alla Settimana 12. |
|
| E.2.2 | Secondary objectives of the trial |
Standardized Area Under The Curve (AUC) for Forced Expiratory Volume
in one second (FEV1) for different time spans(0-24h, 0-12h, 12-24h)
post dosing at Week 12
●Health Status Assessment by St. George's Respiratory Questionnaire
(SGRQ) after 12-and 26-week treatment
●Breathlessness assessed by Transition Dyspnea Index (TDI) after 12
and 26 weeks treatment
●Trough Forced Expiratory Volume in one second (FEV1) at Day 1 and
Week 26
●Standardized Area Under the Curve (AUC) for Forced Expiratory Volume
in one second (FEV1) post dosing at Week 26
●Forced Vital Capacity (FVC) at individual timepoints throughout
treatment period
●Forced Expiratory Volume in one second (FEV1) at all individual
timepoints throughout treatment period
●Inspiratory Capacity (IC) at individual timepoints throughout treatment
period
●Rescue medication use
●Daily Symptom Score
●Safety and Tolerability
●Standardized AUC for Forced Expiratory Volume in one second (FEV1) post dosing on Day 1 |
●Area standardizzata sotto la curva (AUC) per Volume espiratorio forzato in 1 secondo (FEV1) per diversi intervalli di tempo (0-24h, 0-12h, 12-24h)
post-dosaggio a Sett 12.●Valutaz stato di salute mediante Questionario sulla respirazione di St. George (SGRQ) dopo trattamento alla Sett 12 e 26.●Affanno valutato mediante Transition Dyspnea Index (TDI) dopo il trattamento di 12 e 26 sett.
● Volume espiratorio forzato in 1 secondo (FEV1) al Giorno 1 e alla Sett 26.● Area standardizzata sotto la curva (AUC) per il Volume espiratorio forzato in 1 secondo (FEV1) post-dosaggio alla Sett 26.●Capacità vitale forzata (FVC) in singoli punti temporali durante tutto il periodo di trattamento.● FEV1 in tutti i singoli punti temporali durante tutto il periodo di trattamento.●Capacità inspiratoria (IC) in singoli punti temporali durante tutto il periodo di trattamento.●Uso di un farmaco di soccorso.●Punteggio relativo ai sintomi quotidiani●AUC per FEV1 post-dosaggio Giorno1 |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
•Written informed consent must be obtained before any assessment is performed.
•Male and female adults aged ≥40 years
•Patients with stable COPD according to the current GOLD strategy (GOLD 2014).
•Current or ex-smokers who have a smoking history of at least 10 pack years. An ex-smoker may be defined as a subject who has not smoked for ≥ 6 months at screening.
•mMRC grade of at least 2 at Visit 101.
•Patients with airflow limitation indicated by a post-bronchodilator FEV1 ≥ 30 % and <80 % of the predicted normal, and a post-bronchodilator
FEV1/FVC < 0.70 at Visit 101. |
• Deve essere ottenuto un consenso informato scritto prima di eseguire qualsiasi valutazione.
• Uomini e donne adulti di età ≥40 anni
• Pazienti con BPCO stabile secondo la strategia GOLD corrente (GOLD 2014).
• Fumatori attuali o ex fumatori che hanno una storia di tabagismo di almeno 10 pacchetti-anno. Un ex-fumatore è definito come un soggetto che non fuma da ≥6 mesi al momento dello screening.
• Grado mMRC almeno pari a 2 alla Visita 101.
• Pazienti con limitazione del flusso d’aria indicato da una FEV1 post-broncodilatatore ≥30% e <80% del valore normale previsto e un rapporto FEV1/FVC post-broncodilatatore <0,70 alla Visita 101.
|
|
| E.4 | Principal exclusion criteria |
•Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
•Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods
of contraception during dosing of study treatment.
•Patients with Type I or uncontrolled Type II diabetes.
•Patients with a history of long QT syndrome or whose QTc measured at run-in (Fridericia method) is prolonged (>450 ms for males and >460 for
females) and confirmed by a central assessor.
•Patients requiring long term oxygen therapy prescribed for >12 h per day.
•Patients with any history of asthma. |
• Donne incinte o che allattano, in cui la gravidanza è definita come lo stato di una donna dopo il concepimento e fino al termine della gestazione, confermata da un test di laboratorio hCG positivo.
• Donne in età fertile, definite come tutte le donne fisiologicamente in grado di iniziare una gravidanza, a meno che non stiano usando metodi contraccettivi efficaci durante l'assunzione del trattamento sperimentale.
• Pazienti con diabete di tipo I o II non controllato.
• Pazienti con una storia di sindrome del QT lungo o il cui QTc misurato all'inserimento (metodo Fridericia) è prolungato (>450 ms per gli uomini e >460 per le donne) e confermato da un valutatore centrale. (Questi pazienti non devono essere sottoposti a nuovo screening).
• Pazienti che necessitano di ossigenoterapia a lungo termine prescritta per >12 ore al giorno.
• Pazienti con una storia di asma.
|
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| Trough Forced Expiratory Volume in 1 second (FEV1) (defined as mean evaluation at 23 h 15 min and 23 h 45 min post dose) |
| Volume espiratorio forzato in 1 secondo (FEV1) (definito come valutazione media dei valori alle 23h e 15 min e 23h e 45 min dopo la somministrazione della dose) |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
| E.5.2 | Secondary end point(s) |
As secondary endpoints, the degree of bronchodilation produced by the
once and twice daily therapies over 24 hours will be measured in terms
of post dose FEV1 AUC0-24h at week 12 and week 26; differences
between the therapies in the level of bronchodilation produced in the
morning and evening/ overnight will be assessed in terms of FEV1 AUC0-
12h and FEV1 AUC12-24h. In addition, to determine the impact of dosing
regimen on the degree of bronchodilation immediately prior to dosing in
the morning, assessments of pre dose trough FEV1 will be performed at
Day 1, Week 12 and Week 26. |
| Come endpoint secondari si misurerà il grado di broncodilatazione prodotto dalle terapie che prevedono una somministrazione quotidiana della dose una e due volte al giorno nelle 24 ore; tale misurazione avverrà in termini di FEV1 AUC0-24h post-dose alla Settimana 12 e 26; differenze tra le terapie nel livello di broncodilatazione prodotto al mattino e alla sera/notte saranno valutate in termini di FEV1 AUC0-12h e FEV1 AUC12-24h. Inoltre, per determinare l’impatto del regime di dosaggio sul grado della broncodilatazione immediatamente prima della dose del mattino, saranno eseguite delle valutazioni di pre-dose mediante FEV1 al Giorno 1, alla Settimana 12 e alla Settimana 26. |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
| day 1, week 12 and week 26 |
| Giorno 1, Settimana 12 e Settimana 26 |
|
| 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 | 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 | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | Yes |
| 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 | Yes |
| E.8.2.3.1 | Comparator description |
Glicopirronio bromuro 22 microgrammi (di frazione attiva distribuita) due volte al giorno
|
| Glycopyrronium bromide 22 micrograms (of active moiety delivered) b.i.d |
|
| 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
| Yes |
| E.8.4 | The trial involves multiple sites in the Member State concerned | No |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 65 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
| Belgium |
| Bulgaria |
| Czech Republic |
| Finland |
| France |
| Germany |
| Hungary |
| Israel |
| Italy |
| Poland |
| Romania |
| Russian Federation |
| Sweden |
| United Kingdom |
|
| 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 | 2 |
| E.8.9.1 | In the Member State concerned months | 4 |
| E.8.9.1 | In the Member State concerned days | 0 |
| 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 | 5 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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