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Prospective, randomized, cross-over, multicenter, trial comparing the efficacy and tolerability of nasal irrigation with Respimer® mineral salts solution versus saline solution both administered with Respimer® Netiflow® medical device among patients aged ≥ 11 years and older with cystic fibrosis and suffering from chronic rhinosinusitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Respimer Netiflow mineral salts solution | Experimental | Nasal irrigation with Respimer Netiflow mineral salts solution, 4 times/day during 8 weeks using Respimer Netiflow class I medical device |
|
| Saline solution | Active Comparator | Nasal irrigation with saline solution , 4 times/day during 8 weeks using Respimer Netiflow class I medical device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saline solution | Other | a nasal irrigation care |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in quality of life among subjects undergoing nasal irrigation with Respimer® Netiflow® mineral salts solution compared to saline solution between inclusion and the end of treatment period. | Quality of life to be assessed over an 8 weeks period of nasal wash using SNOT-20 questionnaire | over an 8 weeks period |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical status evolution among subjects undergoing nasal irrigation with Respimer® Netiflow® mineral salts solution to saline solution between inclusion and the end of treatment period. | Clinical status to be assessed after 4 and 8 weeks of nasal wash using Lund-Kennedy Symptomatic Score (LKSS) | over an 8 weeks period |
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Inclusion Criteria:
• Patient with Cystic Fibrosis with or without lung transplant;
Exclusion Criteria:
Patients with significant obstruction of the nasal passages due to:
a mucocele,
polyposis causing nasal obstruction> 90% or
severe malformation of the septum causing a nasal obstruction> 90% in whom surgical treatment is recommended;
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ORL et Chirurgie Cervico-faciale Centre Hospitalier Intercommunal (CHI) de Créteil | Créteil | 94010 | France |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Respimer Netiflow | Other | a nasal irrigation care |
|
|
| Endoscopic status evolution among subjects undergoing nasal irrigation with Respimer® Netiflow® mineral salts solution to saline solution between inclusion and the end of treatment period. |
Endoscopic status to be assessed after 4 and 8 weeks of nasal wash using Lund-Kennedy Endoscopic Score (LKES) |
| over an 8 weeks period |
| Mucociliary transport change among subjects undergoing nasal irrigation with Respimer® Netiflow® mineral salts solution to saline solution between inclusion and the end of treatment period. | Mucociliary transport to be assessed after 4 and 8 weeks of nasal wash using saccharine test | over an 8 weeks period |
| Evolution of nasal bacterial pathogens among subjects undergoing nasal irrigation with Respimer® Netiflow® mineral salts solution to saline solution between inclusion and the end of treatment period. | Evolution of nasal bacterial pathogens to be assessed by bacteriologic swab within ethmoid nasal cavities after 4 and 8 weeks of nasal wash | over an 8 weeks period |
| Patient treatment acceptance of nasal irrigation with Respimer® Netiflow® medical device | Patient treatment acceptance to be assessed by Morisky score after 4 and 8 weeks of nasal wash | over an 8 weeks period |
| Occurrence of adverse events : taste impairment, epistaxis, nasal irritations, nasal burning | Adverse events to be assessed based on vigilance tracking during the whole study period | over an 8 weeks period |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |