E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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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 | 16.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10010952 |
E.1.2 | Term | COPD |
E.1.2 | System Organ Class | 100000004855 |
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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 this study is to assess the inspiration profile through the NEXThaler® device in COPD patients with varying degrees of airflow limitation as per GOLD 2013 (updated) spirometric classification of disease severity. |
L’obiettivo primario di questo studio é di valutare il profilo del flusso inalatorio attraverso l’inalatore a polvere secca NEXThaler® in pazienti BPCO con diversi gradi di limitazione respiratoria secondo la classificazione spirometrica di severità della malattia GOLD 2013 (aggiornata). |
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E.2.2 | Secondary objectives of the trial |
The secondary objective of the study is to evaluate the potential correlation between the lung function parameters measured by spirometry at clinic and the variables measured by acoustic monitoring technology during the inspiratory manoeuvre. |
L’obiettivo secondario di questo studio è di valutare la potenziale correlazione tra i parametri della funzionalità polmonare misurata attraverso la spirometria al centro e le variabili misurate attraverso la tecnologia del monitoraggio acustico durante la manovra inspiratoria. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Written informed consent obtained from the patient and/or the legal representatives
2. Inpatients and outpatients of both sexes, aged ≥ 40 years
3. Documented clinical diagnosis (within the past 6 months) of COPD with varying degrees of airflow limitation based on Spirometric classification of disease severity according to GOLD 2013 (updated) guidelines with a smoking history of at least 10 pack years (pack-years = the number of cigarette packs per day times the number of years). Current smokers and ex-smokers are eligible
4. A cooperative attitude and ability to use DPIs and to be trained in the proper use of the NEXThaler® as confirmed by the activation of the training device BAM |
1. Consenso Informato scritto ottenuto dal paziente
2. Pazienti ricoverati e non, di entrambi i sessi, con età ≥ 40 anni
3. Diagnosi clinica documentata (negli ultimi 6 mesi) di BPCO con vari gradi di limitazione respiratoria secondo la classificazione spirometrica di severità della malattia GOLD 2013 (aggiornata) con un passato da fumatore di almeno 10 pacchetti / anno (un pacchetto / anno = numeri di pacchetti di sigarette fumati al giorno moltiplicato per il numero di anni). Sia fumatori attuali che ex-fumatori sono arruolabili.
4. Attitudine alla collaborazione e abilitá nell’uso del NEXThaler® e ad essere trainati sull’uso corretto del NEXThaler® come confermato dall’attivazione del BAM dell’apparecchio per il training
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E.4 | Principal exclusion criteria |
1. Pregnant women confirmed by a positive pregnancy test or nursing (lactating) women (if applicable)
2. Diagnosis of asthma
3. Diagnosis of restrictive lung disease
4. Allergy to any component of the placebo treatment
5. Inability to comply with study procedures or treatment
6. Significant unstable medical history of and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any previously documented laboratory abnormality indicative of a significant underlying condition, that may interfere with patient’s safety, compliance, or study evaluations, according to the investigator’s opinion. |
1. Donna in gravidanza confermata da un test di gravidanza positivo o donna in fase di allattamento
2. Diagnosi di asma
3. Diagnosi di malattia polmonare restrittiva
4. Allergia ai componenti del placebo
5. Incapacità di aderire alle procedure dello studio o al trattamento
6. Anamnesi positiva per significativa instabilità clinica e/o in trattamento per malattie cardiache, renali, neurologiche, epatiche, endocrine, o ogni anormalità di laboratorio, precedentemente documentata, indicativa di condizione patologica associata significativa che possa interferire con la sicurezza del paziente, adesione allo studio, o con le valutazioni dello studio secondo l’opinione dello sperimentatore
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Explorative study To Assess The Inhalation Profile |
Studio esplorativo per valutare il profilo inalatorio |
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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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
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 | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 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
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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 | 8 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
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 |