Evaluation of the Safety of the Medical Device Simeox®

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the medical device simeox is safe in the treatment of respiratory diseases, in comparison with traditional physiotherapy.

Official Title
-----------------
Prospective Trial for the Evaluation of Safety, Tolerability and Efficacy of the Medical Device Simeox ® Compared to Traditional Respiratory Physiotherapy Techniques for Airway Secretion Clearance

Conditions
-----------------
Broncho-degenerative Disease, Chronic Obstructive Airway Disease, Cystic Fibrosis, Idiopathic Bronchiectasis, Ciliary Dyskinesia, Chronic Bronchitis

Intervention / Treatment
-----------------
* Device: Simeox
* Procedure: Physiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient over 18, male or female. Patient affected by broncho-degenerative disease, chronic obstructive airway disease, cystic fibrosis, idiopathic bronchiectasis, ciliary dyskinesia and/or chronic bronchitis. Hospitalization for a minimum of five days or a maximum of 8 days. Bronchial clearance is usually productive. FVC and / or FEV <85% predicted, with stable lung function. Agreement to participate to the study and signature of the informed consent form Social security coverage. Exclusion Criteria: Patient infected with bacteria resistant to antibiotics. Bronchial clearance is not usually productive. Patient with contra-indication for physiotherapy bronchial clearance. Patient who received a lung transplant. Care requires more than 2 sessions of chest physiotherapy daily. Duration of mechanical ventilation > 8h/day. Patient with an episode of hemoptysis during the month before inclusion. Patient with an episode of pneumothorax during the last month. Pregnant or lactating women. Patient with a disability and/or unwillingness to follow protocol requirements. Patient participating in another clinical study or having tested an experimental drug within 30 days prior to his inclusion in the study. Patient ( s) with another condition which, according to the investigator , may interfere with the result or conduct of the trial and thus justify their non- inclusion in the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Physiotherapy<br>Traditional techniques | Device: Simeox<br> <br> Procedure: Physiotherapy<br> <br> |
| Experimental: simeox<br>Medical device | Device: Simeox<br> <br> Procedure: Physiotherapy<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of the simeox® | Adverse events related or not to the simeox® | Day 8 |