E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic obstructive pulmonary disease |
Malattia polmonare ostruttiva cronica (COPD) |
|
E.1.1.1 | Medical condition in easily understood language |
COPD |
Malattia polmonare ostruttiva cronica |
|
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 | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10010952 |
E.1.2 | Term | COPD |
E.1.2 | System Organ Class | 10038738 - Respiratory, thoracic and mediastinal disorders |
|
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 |
The primary objective of the study is to evaluate the efficacy of inhaled
AZD5423 300μg lung deposited dose OD compared with placebo in COPD
patients. |
L’obiettivo primario dello studio è valutare l’efficacia di una dose di AZD5423 300 μg (dose depositata nel polmone) una volta al giorno, rispetto al placebo nei pazienti con BPCO. |
|
E.2.2 | Secondary objectives of the trial |
- To evaluate the efficacy of inhaled AZD5423 75μg lung deposited dose
OD versus placebo in COPD patients
- To evaluate the efficacy of inhaled AZD5423 compared with
budesonide in COPD patients
- To evaluate the effect on the HPA-axis of AZD5423
- To evaluate the effect on systemic inflammation
- To assess the systemic exposure of AZD5423 |
•Valutare l’efficacia di una dose AZD5423 di 75 μg (dose depositata nel polmone) una volta al giorno rispetto a placebo nei pazienti con BPCO.
•Valutare l’efficacia di AZD5423 inalato rispetto a budesonide nei pazienti con BPCO
•Valutare l’effetto di AZD5423 sull’asse ipotalamo-ipofisario (HPA)
•Valutare l’effetto di AZD5423 sull’infiammazione sistemica
•Valutare l’esposizione a livello sistemico dell’AZD5423 |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Post-bronchodilator FEV1 ≥40 and ≤ 80% of the predicted normal
value
2. Post-bronchodilator FEV1/FVC <0,7
3. Reversibility of airway obstruction according to reversibility test
performed at visit 2, defined as an increase in FEV1 of ≥10% relative
baseline after inhalation of in total 400 μg salbutamol or 1 mg
terbutaline sulphate
4. Current or ex-smokers with a smoking history equivalent to at least
10 pack years (1 pack year = 20 cigarettes smoked per day for one year)
5. Clinical diagnosis of COPD for more than 1 year at Visit 1, according
to GOLD guidelines |
1. FEV1 post-broncodilatatore ≥ 40 e ≤ 80% del valore normale predetto
2. Rapporto FEV1/FVC post-broncodilatatore ≤ 0.7
3. Reversibilità dell’ostruzione delle vie aeree in accordo al test di reversibilità effettuato alla Visita 2, definita come un aumento del valore di FEV1 ≥ 10% rispetto al valore baseline dopo inalazione di un totale di 400 microg di salbutamolo o 1 mg di terbutalina solfato
4. Fumatori o ex- fumatori con una storia di tabagismo equivalente ad almeno 10 pacchetti per anno (1 pacchetto per anno = 20 sigarette fumate al giorno per 1 anno)
5. Diagnosi clinica di BPCO da ameno 1 anno alla Visita 1, in accordo alle linee guida GOLD |
|
E.4 | Principal exclusion criteria |
1.Significant disease or disorder (eg, cardiovascular, pulmonary other than COPD,gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine,metabolic, malignant, psychiatric, major physical impairment)
2.Any clinically relevant abnormal findings in clinical chemistry, haematology, urinalysis, physical examination, pulse, blood pressure or ECG
3.Requirement for long term oxygen therapy
4.An exacerbation of COPD, defined as use of oral or parenteral glucocorticosteroids or oral/parenteral antibiotics or hospitalization related to COPD
5.Participation in or scheduled for an intensive COPD rehabilitation program |
1. Gravi malattie o disturbi (es. cardiovascolare, polmonare diversa dalla BPCO, gastrointestinale, epatica, renale, neurologia, muscolo-scheletrica, endocrina, metabolica, maligna, psichiatrica, grave menomazione fisica)
2. Qualsiasi risultato anomalo clinicamente rilevante negli esami di chimica clinica, ematologici, delle urine, esame obiettivo, del polso, pressione sanguigna o EGC
3. Necessità di ossigenoterapia per un periodo prolungato
4. Un aggravamento della BPCO, definito dal ricorso all’uso di glucocorticosteroidi orali o parenterali o di antibiotici orali/parenterali o dal ricovero collegato alla BPCO
5.Partecipazione, avvenuta o prevista, ad un programma intensivo di riabilitazione dalla BPCO |
|
E.5 End points |
E.5.1 | Primary end point(s) |
To evaluate the efficacy of inhaled AZD5423 300μg lung deposited dose
OD compared with placebo in COPD patients |
Valutare l’efficacia di una dose di AZD5423 300 μg (dose depositata nel polmone) una volta al giorno, rispetto al placebo nei pazienti con BPCO. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
At weeks 8 to 12 of randomised treatment |
Dalla settimana 8 fino alla 12 del trattamento randomizzato |
|
E.5.2 | Secondary end point(s) |
- To evaluate the efficacy of inhaled AZD5423 75μg lung deposited dose
OD versus placebo in COPD patients
- To evaluate the efficacy of inhaled AZD5423 compared with
budesonide in COPD patients
- To evaluate the effect on the HPA-axis of AZD5423
- To evaluate the effect on systemic inflammation
- To assess the systemic exposure of AZD5423 |
•Valutare l’efficacia di una dose AZD5423 di 75 μg (dose depositata nel polmone) una volta al giorno rispetto a placebo nei pazienti con BPCO.
•Valutare l’efficacia di AZD5423 inalato rispetto a budesonide nei pazienti con BPCO
•Valutare l’effetto di AZD5423 sull’asse ipotalamo-ipofisario (HPA)
•Valutare l’effetto di AZD5423 sull’infiammazione sistemica
•Valutare l’esposizione a livello sistemico dell’AZD5423 |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. The efficacy of inhaled AZD5423 75μg will be assessed at weeks 2 to
4 of randomised treatment
2. The comparison versus budesonide will be assessed at weeks 8 to 12
of randomised treatment
3. The effect on the HPA -axis and on systemic inflammation will be
assessed at week 4 and week 12
4. Systemic exposure will be assessed at week 4 and week 12 |
1. L'efficacia di 75 microg di AZD5423 per via inalatoria saranno valutati alla settimane 2 fino alla 4 del trattamento randomizzato
2. Il confronto rispetto a budesonide sarà valutati alle settimane 8 fino alla 12 del trattamento randomizzato
3. L’effetto di AZD5423 sull’asse ipotalamo-ipofisario (HPA) e sulla infiammazione sistemica sarà valutata alla settimana 4 ed alla settimana 12.
4. L’esposizione a livello sistemico dell’AZD5423 sarà valutata alla settimana 4 ed alla settimana 12. |
|
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 | Yes |
E.6.7 | Pharmacodynamic | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | 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) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
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 | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 29 |
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 | No |
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 |
Russian Federation |
Ukraine |
|
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 | 0 |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |