Clinical trial NCT04010253: Impact of Bronchial Drainage Technique by the Medical Device Simeox® on Respiratory Function and Symptoms in Adult Patients With Cystic Fibrosis
Official title: Impact of Bronchial Drainage by the Medical Device Simeox® on Function and Respiratory Symptoms Compared to Manual Autogenous Drainage Physiotherapy in Adult Cystic Fibrosis Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cystic Fibrosis
Keywords: Cystic Fibrosis
Physiotherapy
Drainage
Lead sponsor: Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
Sponsor class: OTHER
First posted: 2019-07-08
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The main objective of the study is to evaluate the short-term effects of the airway clearance technique by the medical device Simeox (Physio Assist, France) versus Autogenic Drainage, on the pulmonary function of adult patients with stable cystic fibrosis. To analyse these effects, the investigators used forced oscillation technique measured by TremoFlo™ C-100 Airwave Oscillometry System™ (THORASYS Thoracic Medical Systems Inc. Montreal, Quebec, Canada) with an evaluation of the perceived clinical benefits.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of cystic fibrosis confirmed
* Age ≥18 years
* 30% \<FEV1 \<70% predicted
* Presence of bronchial congestion reported by the patient or the investigator

Exclusion Criteria:

* Uncontrolled asthma
* Pneumothorax \<6 weeks
* Recent severe hemoptysis \<6 weeks
* Patient registered on the transplant list
* Exacerbation within 4 weeks (3 months if hospitalization) before screening
* Cardiovascular disorders, electrocardiogram (ECG) parameters or clinically significant respiratory (non-cystic fibrosis) conditions
* Patients unable to perform measurements of ROF, spirometry, plethysmography.
* Any contraindication to manual or instrumental physiotherapy.
* Pregnancy, breastfeeding.
* Patient under tutorship or curatorship
* No affiliation to the French social security
* Patient using Simeox at home
* Patient under Trikafta for less than 6 weeks.
* Patient using Simeox more than twice a week during physiotherapy sessions, not wanting a washout period of 7 days before inclusion

Primary outcomes:
measure: Low frequency resistance R5
timeFrame: 1 month
Secondary outcomes:
measure: Comparison of the impact of Simeox® bronchial drainage compared to autogenous drainage on respiratory symptoms: dyspnea, congestion and fatigue
timeFrame: 1 month
measure: Evaluation of the distal and / or proximal decluttering by the two techniques, according to the improvement profile of the forced oscillations
timeFrame: 1 month
measure: Evaluation of the impact of Simeox® bronchial drainage vs autogenous drainage by spirometry and plethysmography (distension and resistance)
timeFrame: 1 month
measure: Evaluation of correlations between clinical benefit and changes in functional respiratory investigations (forced oscillations, spirometry, plethysmography)
timeFrame: 1 month
Other outcomes:
Locations:
city: Amiens
country: France
facility: CH Amiens
city: Dijon
country: France
facility: Hôpital la Bocage CHRU de Dijon
city: Lille
country: France
facility: CHRU Lille - Hopital Calmette
city: Lyon
country: France
facility: GH Sud - Hospices Civils de Lyon
city: Nice
country: France
facility: CH Nice
city: Roscoff
country: France
facility: Soins de Suite Nutritionnels et Respiratoires -Fondation IDLYS
city: Rouen
country: France
facility: CHU de Rouen
city: Toulouse
country: France
facility: Hopital Larrey
Study officials:
affiliation: CHRU LILLE
name: Thierry PEREZ, MD
role: PRINCIPAL_INVESTIGATOR
References: