E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated | |
E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
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 | 10010953 |
E.1.2 | Term | COPD exacerbation |
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 |
To evaluate the efficacy of nebulization of β2-mimetics by a vibrating membrane device under HDN during the decompensation of COPD. |
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E.2.2 | Secondary objectives of the trial |
- Evaluate the efficacy of nebulization of β2-mimetics by a vibrating membrane device (DEP, CV, Rint and P0.1) and the clinic (Borg scale, dyspnea score, respiratory rate, SpO2) Under HDN during the decompensation of COPD - To evaluate the feasibility, tolerance and evolution of hematosis after nebulization of β2-mimetics administered by high-flow nasal. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
All patients in the Poitiers University Hospital admitted for acute decompensation of chronic obstructive pulmonary disease (COPD, continuous dyspnea asthma) admitted to the medical resuscitation department and Continuing Care Units will be included in the study, They have the following inclusion criteria: - Age ≥ 18 years - Respiratory decompensation with respiratory acidosis (pH> 7.25, FR <35, Glasgow 15), - Indication to a treatment with β2-mimetic in nebulization, - Patient capable of answering simple questions despite dyspnea, - Information given to the patient and collection of consent. - Free subject, without guardianship or curatorship or subordination - Patients benefiting from a Social Security scheme or benefiting from it through a third party
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E.4 | Principal exclusion criteria |
All patients will be excluded from the study if one of the following criteria - Age <18 years - Indication to an urgent intubation, - Contra-indication to β2-mimetics, - Existence of non-respiratory organ failure (hemodynamic failure, neurological failure) - Patients with non-cardio-selective beta-blockers during the study, - Patients not benefiting from a Social Security scheme or not benefiting from it through a third party - Persons benefiting from enhanced protection, ie minors, pregnant women, nursing mothers, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social institution, adults under legal protection, and Patients in emergencies. - Pregnant or nursing women, women of childbearing age who do not have effective contraception (hormonal / mechanical: oral, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total ovariectomy ) |
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E.5 End points |
E.5.1 | Primary end point(s) |
Evolution of the Maximum Expiratory Volume to the First Second (FEV) between the different times of the study. |
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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) |
- Evolution of the clinical data measured during the clinical examination at the different times of the study. - Evolution of hematosis data collected according to a non-invasive transcutaneous method, as performed during the standard monitoring of patients hospitalized in continuing care units or intensive care units. -Evolution of the spirometric data measured at the different times of the study. |
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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 | Yes |
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 | 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) | Yes |
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 | 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 | No |
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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LVLS + 6 months for analysis |
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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 | |
E.8.9.1 | In the Member State concerned months | 18 |
E.8.9.1 | In the Member State concerned days | |