Polyp of Ethmoidal SinusNETIFLOWNCT02559284
RESPIMER® Netiflow® vs. Saline Solutions During Nasal Irrigation Following Bilateral Ethmoidectomy (Nasal Polyposis)
A study testing A postoperative care after ethmoid sinus surgery in people with Polyp of Ethmoidal Sinus and Surgery, run by Laboratoire de la Mer at 8 sites in France.
Trial summary
The main objective of this study is to compare the effects of RESPIMER® NetiFlow® solution and device versus saline solution (0.9% NaCl), the standard treatment, used with RESPIMER® NetiFlow® device, both used postoperative care, in the context of ethmoid sinus surgery, at 14 days post-surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Polyp of Ethmoidal Sinus, Surgery
- What is being tested?
- A postoperative care after ethmoid sinus surgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 8 sitesFrance
- Study dates
- Apr 2015to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females between 18 and 65 years of age
- Subject in need of sinus surgery as bilateral total ethmoidectomy using an endoscopic endonasal approach whose pathology is the result of a:
- Sinonasal polyposis alone
- Sinonasal polyposis associated with asthma and / or intolerance to NSAIDs
- Free and informed written consent
- Member or beneficiary of a social security program
Who cannot join
- Oral corticosteroid treatment since less than 2 months
- Premenopausal women not using effective contraception (oral or intrauterine device)
- Pregnant or nursing women
- Uncontrolled diabetes (not treated or stabilized by treatment)
- HIV-positive status
- Autoimmune diseases affecting the nose and/or sinuses, immune dysfunctions (Wegener's granulomatosis, Churg-Strauss syndrome, Common Variable Immunodeficiency, sarcoidosis...), or malignant diseases (unclear histology)
Show all 14Show fewer
- All contraindication of RESPIMER® NetiFlow®
- All diseases resulting in difficulty coughing or swallowing
- Ongoing or past radiation treatment to the head and neck
- Ongoing or recent chemotherapy (within a three-month period)
- Subjects using anticoagulants
- Subjects taking part in another study that includes an exclusion period coinciding with that of the run-in period of this study
- Subjects placed under judicial protection
- Subjects who suffer from severe physical or psychological problems and whose condition can, according to the investigator, affect compliance with the study
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
Service d'Oto-rhino-laryngologie - Clinique Saint-Augustin
Bordeaux, Gironde, 33074
Service d'Oto-rhino-laryngologie et Chirurgie cervico-faciale - Hôpital Pellegrin
Bordeaux, Gironde, 33076
ORL et Chirurgie Cervico-faciale - Centre Hospitalier Intercommunal (CHI) de Créteil
Créteil, Val-de-Marne, 94010
Service ORL et Chirurgie cervico-faciale - CHRU Lille
Lille, Nord, 59037
Service ORL et Chirurgie Cervico-faciale - CHRU Nancy
Nancy, Meurthe-et-Moselle
Service d'oto-rhino-laryngologie - CHU de Nantes
Nantes, Loire-Atlantique, 44093
ORL et Chirurgie Cervico-faciale - Pôle Voies Respiratoires - CHU Toulouse
Toulouse, Haute-Garonne, 31059
Service d'ORL et Chirurgie cervico faciale - CHRU Tours
Tours, Indre-et-Loire, 37044
About this study
Official title: A Comparative, Multicenter and Randomized Study Evaluating the Safety and Efficacy of RESPIMER® Netiflow® Versus Saline Solutions During Nasal Irrigation Following Bilateral Ethmoidectomy in the Treatment of Nasal Polyposis.
The main objective of this study is to compare the effects of RESPIMER® NetiFlow® solution and device versus saline solution (0.9% NaCl), the standard treatment, used with RESPIMER® NetiFlow® device, both used postoperative care, in the context of ethmoid sinus surgery, at 14 days post-surgery.
Read the detailed description
This is a comparative study between two postoperative treatments following ethmoid sinus surgery. The purpose of this study is to compare the effect of RESPIMER® NetiFlow® solution on nasal tissue repair versus saline solution (0.9% NaCl), the standard treatment.
The type of surgery selected for this study is total endoscopic ethmoidectomy. This is a frequently used standard surgery that requires nasal cleansing for an average of 28 days. This process allows the regeneration of the nasal epithelial lining of the wound (areas of exposed bone), as well as the healing of swelling and scarring due to the surgery.
The follow up last 28 days with 4 visits (D7, D14, D21 and D28).
RESPIMER® NetiFlow® : device of class I, with CE mark, in the indication of sinus postoperative care.
- Conditions
- Polyp of Ethmoidal Sinus, Surgery
- Being tested
- A postoperative care after ethmoid sinus surgery
- Keywords
- Saline Solution, Isotonic / Administration & dosage, Therapeutic Irrigation / methods, Postoperative Care / methods, Quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A postoperative care after ethmoid sinus surgeryOther
A comparison of two products used for nasal cavity cleansing, at the rate of 4 washes/day (240mL per wash), as local postoperative care following endoscopic sinus surgery. This surgery, known as an ethmoidectomy, aims to improve sinus ventilation, treat the chronically infected area, and remove polyps that cause nasal obstruction.
Detailed information concerning the purpose of nasal irrigation, as well as how to use and clean the device, will be given to patients upon inclusion.
The nasal washing procedure will be as follow:
- Washing both nostrils using 180mL of solution distributed equally on each side to remove crusting and clotting
- Gentle blowing of the nose
- Rinsing both nostrils with the remaining 60mL of solution distributed equally on each side (no nose-blowing).
| Study group | Role | What they receive |
|---|---|---|
| A - Experimental | Experimental | Treatment Arm: 100 patients using Respimer® NetiFlow® solution as standard treatment for healing of nasal surgery wounds following an endoscopic ethmoidectomy as a postoperative care after ethmoid sinus surgery Receives: Other: A postoperative care after ethmoid sinus surgery |
| B - Comparator | Active comparator | Control Arm: 100 patients using saline solution (0.9% NaCl) as standard treatment for healing of nasal surgery wounds following an endoscopic ethmoidectomy as a postoperative care after ethmoid sinus surgery Receives: Other: A postoperative care after ethmoid sinus surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Superior healing of nasal mucosa repair 14 days following endoscopic sinus surgery, between the RESPIMER® NetiFlow® solution and the saline solution arms
Based on a ≥8 points difference in the total RHINO QoL score between the two groups.
Measured: D14 meaning 14 days (plus or minus 3 days) after surgery
Secondary outcomes (8)
Efficacy in optimizing airway clearance and restoring respiratory health, as well as overall quality of life
Compare the efficacy of RESPIMER® NetiFlow® versus saline solutions in optimizing airway clearance and restoring respiratory health, as well as overall quality of life using:
- RHINO QoL scores (a self-report of nasal congestion, facial pain, anterior and posterior rhinorrhea).
- NOSE nasal obstruction scores.
Measured: Pre-inclusion, D7, D14, D21 and D28
Assess and compare the crusting
Assess and compare the crusting with :
- The number of patients with (whether or not obstruction exists) and without crusting.
- How many days it takes for the crusting to disappear and/or the difference in the total number of care days
Measured: Pre-inclusion, D7, D14, D21 and D28
Assess and compare the tolerability
Assess and compare the tolerability of RESPIMER® NetiFlow® versus saline solutions using a Visual Analog Scale (VAS) (burning sensation in the nose, alterations in taste and smell and epistaxis) (patient record).
Measured: Pre-inclusion, D7, D14, D21 and D28
Additional details on duration of nasal washes
Provide additional details on the duration of nasal washes according to the approved indication (patient record).
Measured: D7, D14, D21 and D28 after surgery
Satisfaction and perceived efficacy of the nasal solution
VAS numerical values assessing the level of patient satisfaction and perceived efficacy in regard to the nasal solution that was used by each group (patient's Case report Form).
Measured: D7, D14, D21 and D28 after surgery
Satisfaction, convenience, ease of administration and ease of cleaning of the RESPIMER® NetiFlow® device
VAS numerical values assessing the RESPIMER® NetiFlow® device in terms of satisfaction, convenience, ease of administration and ease of cleaning (patient's Case report Form).
Measured: D7, D14, D21 and D28 after surgery
Assess functionality of nasal lining
Assess functionality of nasal lining by evaluating mucociliary clearance by rhinoscintigraphy for all patients in the 2 Bordeaux centers' (Bordeaux University Hospital and Saint-Augustin Private Hospital):
- D-1 only for center's Bordeaux, 10 patients in each group (20 patients in total)
- D14 and D21 for all Bordeaux patients', estimated at 50 patients (15 in each group and in addition the same 10 patients of the D-1 visit, in each group).
Measured: D-1, D14, and D21
Efficacy in improving the trophicity of the nasal mucosa within the operated area
Assess the efficacy of RESPIMER® NetiFlow® versus saline solutions in improving the trophicity of the nasal mucosa within the operated area, using a Lund-Kennedy endoscopic score (20 points).
Measured: D14, D21 and D28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2015 (estimated)
- Study startApr 2015
- Primary completionFeb 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (95)Papers the sponsor has linked to this study.
- Other trials for Polyp of Ethmoidal SinusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoire de la Mer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ludovic LE TAILLANDIER de GABORY, MD, PhD, Principal investigator, Coordinator Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02559284
- Sponsor's protocol ID
- P0013
- Acronym
- NETIFLOW
- Status last verified
- Aug 2017
- First submitted
- 22 Sep 2015
- Last updated
- 1 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Homer JJ, England RJ, Wilde AD, Harwood GR, Stafford ND. The effect of pH of douching solutions on mucociliary clearance. Clin Otolaryngol Allied Sci. 1999 Aug;24(4):312-5. doi: 10.1046/j.1365-2273.1999.00265.x.
PubMed 10472466Aarbiou J, Verhoosel RM, Van Wetering S, De Boer WI, Van Krieken JH, Litvinov SV, Rabe KF, Hiemstra PS. Neutrophil defensins enhance lung epithelial wound closure and mucin gene expression in vitro. Am J Respir Cell Mol Biol. 2004 Feb;30(2):193-201. doi: 10.1165/rcmb.2002-0267OC. Epub 2003 Jul 18.
PubMed 12871849Adam P, Stiffman M, Blake RL Jr. A clinical trial of hypertonic saline nasal spray in subjects with the common cold or rhinosinusitis. Arch Fam Med. 1998 Jan-Feb;7(1):39-43. doi: 10.1001/archfami.7.1.39.
PubMed 9443697Bardou O, Trinh NT, Brochiero E. Molecular diversity and function of K+ channels in airway and alveolar epithelial cells. Am J Physiol Lung Cell Mol Physiol. 2009 Feb;296(2):L145-55. doi: 10.1152/ajplung.90525.2008. Epub 2008 Dec 5.
PubMed 19060226Bernstein IL. Is the use of benzalkonium chloride as a preservative for nasal formulations a safety concern? A cautionary note based on compromised mucociliary transport. J Allergy Clin Immunol. 2000 Jan;105(1 Pt 1):39-44. doi: 10.1016/s0091-6749(00)90175-1.
PubMed 10629450Bieger-Farhan AK, Nichani J, Willatt DJ. Nasal septal mucosal contact points: associated symptoms and sinus CT scan scoring. Clin Otolaryngol Allied Sci. 2004 Apr;29(2):165-8. doi: 10.1111/j.0307-7772.2004.00774.x.
PubMed 15113304Boek WM, Keles N, Graamans K, Huizing EH. Physiologic and hypertonic saline solutions impair ciliary activity in vitro. Laryngoscope. 1999 Mar;109(3):396-9. doi: 10.1097/00005537-199903000-00010.
PubMed 10089964Braiman A, Priel Z. Efficient mucociliary transport relies on efficient regulation of ciliary beating. Respir Physiol Neurobiol. 2008 Nov 30;163(1-3):202-7. doi: 10.1016/j.resp.2008.05.010. Epub 2008 May 22.
PubMed 18586580Britton J, Pavord I, Richards K, Wisniewski A, Knox A, Lewis S, Tattersfield A, Weiss S. Dietary magnesium, lung function, wheezing, and airway hyperreactivity in a random adult population sample. Lancet. 1994 Aug 6;344(8919):357-62. doi: 10.1016/s0140-6736(94)91399-4.
PubMed 7914305Buchanan PJ, McNally P, Harvey BJ, Urbach V. Lipoxin A(4)-mediated KATP potassium channel activation results in cystic fibrosis airway epithelial repair. Am J Physiol Lung Cell Mol Physiol. 2013 Jul 15;305(2):L193-201. doi: 10.1152/ajplung.00058.2013. Epub 2013 May 17.
PubMed 23686859Burgel PR, Nadel JA. Roles of epidermal growth factor receptor activation in epithelial cell repair and mucin production in airway epithelium. Thorax. 2004 Nov;59(11):992-6. doi: 10.1136/thx.2003.018879.
PubMed 15516478Campos J, Heppt W, Weber R. Nasal douches for diseases of the nose and the paranasal sinuses--a comparative in vitro investigation. Eur Arch Otorhinolaryngol. 2013 Nov;270(11):2891-9. doi: 10.1007/s00405-013-2398-z. Epub 2013 Feb 28.
PubMed 23455580Chen EY, Yang N, Quinton PM, Chin WC. A new role for bicarbonate in mucus formation. Am J Physiol Lung Cell Mol Physiol. 2010 Oct;299(4):L542-9. doi: 10.1152/ajplung.00180.2010. Epub 2010 Aug 6.
PubMed 20693315Christopher K, Chang J, Goldberg J. Stimulation of cilia beat frequency by serotonin is mediated by a Ca2+ influx in ciliated cells of Helisoma trivolvis embryos. J Exp Biol. 1996;199(Pt 5):1105-13. doi: 10.1242/jeb.199.5.1105.
PubMed 9318930Ciarallo L, Sauer AH, Shannon MW. Intravenous magnesium therapy for moderate to severe pediatric asthma: results of a randomized, placebo-controlled trial. J Pediatr. 1996 Dec;129(6):809-14. doi: 10.1016/s0022-3476(96)70023-9.
PubMed 8969721
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative, Multicenter and Randomized Study Evaluating the Safety and Efficacy of RESPIMER® Netiflow® Versus Saline Solutions During Nasal Irrigation Following Bilateral Ethmoidectomy in the Treatment of Nasal Polyposis.
- ClinicalTrials.gov ID
- NCT02559284
- Acronym / sponsor ID
- NETIFLOW / P0013
- Conditions
- Polyp of Ethmoidal Sinus, Surgery
- Keywords
- Saline Solution, Isotonic / Administration & dosage, Therapeutic Irrigation / methods, Postoperative Care / methods, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Laboratoire de la MerIndustry (pharma, biotech, devices)
- Study start
- Apr 2015 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 24 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this study is to compare the effects of RESPIMER® NetiFlow® solution and device versus saline solution (0.9% NaCl), the standard treatment, used with RESPIMER® NetiFlow® device, both used postoperative care, in the context of ethmoid sinus surgery, at 14 days post-surgery.
Detailed description
This is a comparative study between two postoperative treatments following ethmoid sinus surgery. The purpose of this study is to compare the effect of RESPIMER® NetiFlow® solution on nasal tissue repair versus saline solution (0.9% NaCl), the standard treatment.
The type of surgery selected for this study is total endoscopic ethmoidectomy. This is a frequently used standard surgery that requires nasal cleansing for an average of 28 days. This process allows the regeneration of the nasal epithelial lining of the wound (areas of exposed bone), as well as the healing of swelling and scarring due to the surgery.
The follow up last 28 days with 4 visits (D7, D14, D21 and D28).
RESPIMER® NetiFlow® : device of class I, with CE mark, in the indication of sinus postoperative care.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A - Experimental | Experimental | Other: A postoperative care after ethmoid sinus surgeryTreatment Arm: 100 patients using Respimer® NetiFlow® solution as standard treatment for healing of nasal surgery wounds following an endoscopic ethmoidectomy as a postoperative care after ethmoid sinus surgery |
| B - Comparator | Active comparator | Other: A postoperative care after ethmoid sinus surgeryControl Arm: 100 patients using saline solution (0.9% NaCl) as standard treatment for healing of nasal surgery wounds following an endoscopic ethmoidectomy as a postoperative care after ethmoid sinus surgery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males or females between 18 and 65 years of age
- Subject in need of sinus surgery as bilateral total ethmoidectomy using an endoscopic endonasal approach whose pathology is the result of a:
- Free and informed written consent
- Member or beneficiary of a social security program
Key exclusion criteria (14 listed)
- Oral corticosteroid treatment since less than 2 months
- Premenopausal women not using effective contraception (oral or intrauterine device)
- Pregnant or nursing women
- Uncontrolled diabetes (not treated or stabilized by treatment)
- HIV-positive status
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A postoperative care after ethmoid sinus surgeryA comparison of two products used for nasal cavity cleansing, at the rate of 4 washes/day (240mL per wash), as local postoperative care following endoscopic sinus surgery. This surgery, known as an ethmoidectomy, aims to improve sinus ventilation, treat the chronically infected area, and remove polyps that cause nasal obstruction. Detailed information concerning the purpose of nasal irrigation, as well as how to use and clean the device, will be given to patients upon inclusion. The nasal washing procedure will be as follow: * Washing both nostrils using 180mL of solution distributed equally on each side to remove crusting and clotting * Gentle blowing of the nose * Rinsing both nostrils with the remaining 60mL of solution distributed equally on each side (no nose-blowing). | Other | A - Experimental, B - Comparator |
Primary outcome
Superior healing of nasal mucosa repair 14 days following endoscopic sinus surgery, between the RESPIMER® NetiFlow® solution and the saline solution arms
Time frame: D14 meaning 14 days (plus or minus 3 days) after surgery
Based on a ≥8 points difference in the total RHINO QoL score between the two groups.
8 secondary outcomes
Efficacy in optimizing airway clearance and restoring respiratory health, as well as overall quality of life
Time frame: Pre-inclusion, D7, D14, D21 and D28
Assess and compare the crusting
Time frame: Pre-inclusion, D7, D14, D21 and D28
Assess and compare the tolerability
Time frame: Pre-inclusion, D7, D14, D21 and D28
Additional details on duration of nasal washes
Time frame: D7, D14, D21 and D28 after surgery
Satisfaction and perceived efficacy of the nasal solution
Time frame: D7, D14, D21 and D28 after surgery
Satisfaction, convenience, ease of administration and ease of cleaning of the RESPIMER® NetiFlow® device
Time frame: D7, D14, D21 and D28 after surgery
Assess functionality of nasal lining
Time frame: D-1, D14, and D21
Efficacy in improving the trophicity of the nasal mucosa within the operated area
Time frame: D14, D21 and D28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2017.
- Background: PubMed 10472466Homer JJ, England RJ, Wilde AD, Harwood GR, Stafford ND. The effect of pH of douching solutions on mucociliary clearance. Clin Otolaryngol Allied Sci. 1999 Aug;24(4):312-5. doi: 10.1046/j.1365-2273.1999.00265.x.
- Results publication: PubMed 12871849Aarbiou J, Verhoosel RM, Van Wetering S, De Boer WI, Van Krieken JH, Litvinov SV, Rabe KF, Hiemstra PS. Neutrophil defensins enhance lung epithelial wound closure and mucin gene expression in vitro. Am J Respir Cell Mol Biol. 2004 Feb;30(2):193-201. doi: 10.1165/rcmb.2002-0267OC. Epub 2003 Jul 18.
- Results publication: PubMed 9443697Adam P, Stiffman M, Blake RL Jr. A clinical trial of hypertonic saline nasal spray in subjects with the common cold or rhinosinusitis. Arch Fam Med. 1998 Jan-Feb;7(1):39-43. doi: 10.1001/archfami.7.1.39.
- Results publication: PubMed 19060226Bardou O, Trinh NT, Brochiero E. Molecular diversity and function of K+ channels in airway and alveolar epithelial cells. Am J Physiol Lung Cell Mol Physiol. 2009 Feb;296(2):L145-55. doi: 10.1152/ajplung.90525.2008. Epub 2008 Dec 5.
- Results publication: PubMed 10629450Bernstein IL. Is the use of benzalkonium chloride as a preservative for nasal formulations a safety concern? A cautionary note based on compromised mucociliary transport. J Allergy Clin Immunol. 2000 Jan;105(1 Pt 1):39-44. doi: 10.1016/s0091-6749(00)90175-1.
- Results publication: PubMed 15113304Bieger-Farhan AK, Nichani J, Willatt DJ. Nasal septal mucosal contact points: associated symptoms and sinus CT scan scoring. Clin Otolaryngol Allied Sci. 2004 Apr;29(2):165-8. doi: 10.1111/j.0307-7772.2004.00774.x.
- Results publication: PubMed 10089964Boek WM, Keles N, Graamans K, Huizing EH. Physiologic and hypertonic saline solutions impair ciliary activity in vitro. Laryngoscope. 1999 Mar;109(3):396-9. doi: 10.1097/00005537-199903000-00010.
- Results publication: PubMed 18586580Braiman A, Priel Z. Efficient mucociliary transport relies on efficient regulation of ciliary beating. Respir Physiol Neurobiol. 2008 Nov 30;163(1-3):202-7. doi: 10.1016/j.resp.2008.05.010. Epub 2008 May 22.
- Results publication: PubMed 7914305Britton J, Pavord I, Richards K, Wisniewski A, Knox A, Lewis S, Tattersfield A, Weiss S. Dietary magnesium, lung function, wheezing, and airway hyperreactivity in a random adult population sample. Lancet. 1994 Aug 6;344(8919):357-62. doi: 10.1016/s0140-6736(94)91399-4.
- Results publication: PubMed 23686859Buchanan PJ, McNally P, Harvey BJ, Urbach V. Lipoxin A(4)-mediated KATP potassium channel activation results in cystic fibrosis airway epithelial repair. Am J Physiol Lung Cell Mol Physiol. 2013 Jul 15;305(2):L193-201. doi: 10.1152/ajplung.00058.2013. Epub 2013 May 17.
- Results publication: PubMed 15516478Burgel PR, Nadel JA. Roles of epidermal growth factor receptor activation in epithelial cell repair and mucin production in airway epithelium. Thorax. 2004 Nov;59(11):992-6. doi: 10.1136/thx.2003.018879.
- Results publication: PubMed 23455580Campos J, Heppt W, Weber R. Nasal douches for diseases of the nose and the paranasal sinuses--a comparative in vitro investigation. Eur Arch Otorhinolaryngol. 2013 Nov;270(11):2891-9. doi: 10.1007/s00405-013-2398-z. Epub 2013 Feb 28.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ludovic LE TAILLANDIER de GABORY, MD, PhD principal investigator
Coordinator Investigator
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A postoperative care after ethmoid sinus surgery in people with Polyp of Ethmoidal Sinus and Surgery, run by Laboratoire de la Mer at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Superior healing of nasal mucosa repair 14 days following endoscopic sinus surgery, between the RESPIMER® NetiFlow® solution and the saline solution arms (time frame: D14 meaning 14 days (plus or minus 3 days) after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02559284, which also lists 95 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2017.