[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sinusitis-chronic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sinusitis-chronic":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100451375","phase-3-evaluation-of-the-efficacy-of-azithromycin-in-idiopathic-purulent-oedematous-sinusitis-in-adults-100451375",false,"NCT05157685","Evaluation of the Efficacy of Azithromycin in Idiopathic Purulent Oedematous Sinusitis in Adults","Evaluation of the Efficacy of 3-month Continuous Extended Treatment With Azithromycin in Idiopathic Purulent Oedematous Sinusitis in Adults: a Multicentre Randomised Controlled Trial","SOPAZITHRO","Inclusion Criteria:\n\n* Patient older than 18 years and less than 70 years of age\n* Chronic rhinosinusitis (\\> 12 weeks of evolution) meeting the definition published in the European Paper Position2012 (1) and corresponding exclusively to the following endoscopic and CT criteria:\n\n  * Nasal endoscopy showing bilateral and diffuse involvement associating edema of the mucosa of the nasal cavities and meatus with the presence of mucopurulent secretions in these areas\n  * Nasosinus CT scan showing diffuse and bilateral pansinus opacities involving at least the maxillary sinuses and the anterior and posterior ethmoids\n* Persistent intractable purulent rhinosinusitis despite at least 2 antibiotic therapies\n* Signed informed consent of the patient\n* Membership in a health insurance plan or beneficiary\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding\n* PCOS of identified primary cause (identified immune deficiency, cystic fibrosis, HIV)\n* Chronic non-purulent rhinosinusitis (nasosinusal polyposis, allergic rhinosinusitis)\n* Localized chronic suppurative rhinosinusitis (single sinus, unilateral, frontal or maxillary or sphenoidal)\n* Severe hepatic insufficiency (factor V level \\\u003C 50%)\n* Severe renal insufficiency (stage 4 (GFR \\\u003C 30 ml\u002Fmin\u002F1.73 m2) and\u002For creatinine \\\u003C 40 ml\u002Fmin)\n* Severe heart failure (old age, ischemic heart disease, episode of recurrent cardiac arrest; hypotension, NYHA functional stage III-IV; widened QRS, complex ventricular arrhythmias; hyponatremia (Na \\\u003C135mmol\u002Fl); stage 4 renal failure (GFR \\\u003C 30 ml\u002Fmin\u002F1.73 m2); severely depressed LVEF (\\\u003C 30%)\n* Documented moderate pre-existing sensorineural hearing loss with a mean pure tone threshold in the poorer ear in bone conduction \\>30 dB across all 3 frequencies (500, 1000 and 2000 Hz) or in only one ear (unilateral deafness).\n* Major cognitive impairment or lack of French language skills preventing completion of SNOT-22 and SF-36 questionnaires\n* Patient with galactose intolerance, total lactase deficiency or glucose-galactose malabsorption syndrome (rare hereditary diseases)\n* Patient with peanut or soy allergy\n* Patient allergic to macrolides\n* Patients who are intolerant or allergic to any of the excipients of azithromycin or placebo\n* Treatment with azithromycin in the previous 3 months\n* Long QT on ECG ((\\>440ms for male and \\>450ms for female) or cardiac arrhythmia or bradycardia (\\\u003C60btm).The calculation of the corrected QT should be carried out using the Bazett formula.\n* Hypokalemia or hypomagnesemia on blood ionogram\n* Confirmed or suspected atypical mycobacteriosis\n* Contraindicated drug combinations with macrolides (K-vitamins or drugs containing cisapride, colchicine, ergotamine or dihydroergotamine)\n* Cautionary drug combinations (non-inclusion criteria)\n\n  * Atorvastatin (Increased risk of concentration-dependent rhabdomyolysis-type adverse events due to decreased hepatic metabolism of the cholesterol-lowering drug.\n  * Ciclosporin (risk of increased ciclosporin blood levels and creatinine levels)\n  * Digoxin (increase in digoxemia due to increased absorption of digoxin), Drugs likely to cause torsades de pointes, in particular class IA (e.g. quinidine) and class III (e.g. amiodarone, sotalol) antiarrhythmics, antipsychotics (e.g. phenothiazines, pimozide), tricyclic antidepressants (e.g. citalopram), certain fluoroquinolones (e.g. moxifloxacin, levofloxacin) (increased risk of ventricular rhythm disturbances)\n  * Simvastatin (increased risk of rhabdomyolysis-type adverse effects (concentration-dependent), due to decreased hepatic metabolism of the cholesterol-lowering agent)\n  * Ivabradine (increased risk of ventricular rhythm disorders),\n  * Hypokalemic drugs\n  * Bradycardia drugs\n* Patients with severe cholestasis\n* Patients under guardianship or curatorship\n* Patients with hematologic malignancies who have undergone hematopoietic stem cell transplantation\n* History of facial radiotherapy\n* History of rhinosinus cancer\n* Participation in other category 1 research at the time of inclusion or in the month prior to inclusion","ALL","18 Years","70 Years",{"count":21,"type":22},230,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","Purulent Oedematous Sinusitis (POS) is a particular form of chronic rhinosinusitis observed in 2% of the general population. In spite of its heavy impact on the quality of life, There is no established recommendation for the treatment of primary POS. Long-term low-dose macrolides are currently proposed for these forms of chronic rhinosinusitis when conventional treatments (local corticosteroids, saline rinsing, iterative short courses of antibiotics targeted on pathogens, and surgical opening and drainage) have failed. This treatment with macrolides is currently applied off-label.\n\nThis study aims to assess the efficacy of macrolides in POS. An extensive workup is fulfilled to exclude other forms of chronic rhinosinusitis (Th2 biased inflammatory diseases, allergic diseases) (allergy, nasosinusal polyposis) or those due to cystic fibrosis or immune deficiency.",[28,29],"Sinusitis, Chronic","Sinus Infection Chronic","RECRUITING","2025-08-28",{"date":33,"type":34},"2025-08-29","ACTUAL",{"date":36,"type":34},"2022-11-21",{"date":38,"type":22},"2027-11-21",{"name":40,"class":41},"Centre Hospitalier Intercommunal Creteil","OTHER",13,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":55,"conditions":56,"keywords":60,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":71},"100412050","balloon-sinuplasty-efficiency-in-maxillary-rhinosinusitis-100412050","NCT04645511","Balloon Sinuplasty Efficiency in Maxillary Rhinosinusitis.","A Placebo Controlled Randomised Study of the Balloon Sinuplasty Efficiency in Chronic or Recurrent Maxillary Rhinosinusitis.","Inclusion Criteria:\n\n* Patients at least 18 years old and younger than 70 years old\n* Patients willing to participate in the study\n* Patients whose diseases fill the definitions of chronic or acute recurrent maxillary rhinosinusitis\n* Patients with chronic maxillary rhinosinusitis has not responded to a 3-month trial of topical corticosteroid treatment\n* SNOT-22 points 8 or more in chronic maxillary rhinosinusitis\n* In recurrent acute maxillary rhinosinusitis, no SNOT-22 point limits are used\n* Modified Lund-Mackay inclusion criteria in chronic rhinosinusitis group:\n\n  1. Maxillar 0-2\n  2. Anterior Ethmoid 0-2\n  3. Posterior Ethmoid 0-1\n  4. Sphenoid 0-1\n  5. Frontal 0-1\n  6. Ostiomeatal complex 0 or 2\n\nExclusion Criteria:\n\n* Chronic rhinosinusitis with nasal polyps\n* Notable inflammation in the ethmoidal, sphenoidal or frontal sinuses along with maxillary sinusitis\n* Previous nasal surgery\n* Sinonasal tumor\n* Maxillary rhinosinusitis caused by a dental problem\n* Facial pain caused by other etiologies\n* Cystic fibrosis\n* Gross immunodeficiency\n* Congenital mucociliary problems\n* Non-invasive fungal balls and invasive fungal disease\n* Systemic vasculitis and granulomatous disease\n* Severe systemic diseases\n* Malignancies\n* Pregnancy\n\nDefinitions:\n\nRecurrent acute maxillary rhinosinusitis:\n\n* 4 or more episodes (\\\u003C 12 weeks) of acute rhinosinusitis with typical symptoms per year and no persistent symptoms between the rhinosinusitis episodes (Chan and Kuhn 2009)\n* The diagnosis of the recurrent episodes of acute rhinosinusitis have been made with the following criteria:\n\n  * Increase of symptoms after 5 days or persistent symptoms after 10 days and\n  * During the episode, 2 or more symptoms, one of which should be either nasal blockage\u002Fobstruction or nasal discharge (anterior\u002Fposterior nasal drip)\n  * +\u002F- facial pain\u002Fpressure\n  * +\u002F- reduction or loss of smell (Fokkens et al. 2012) and either\n  * Signs of mucopurulent discharge primarily from the middle meatus seen in anterior rhinoscopy or nasoendoscopy and\u002For\n  * Oedema\u002Fmucosal obstruction primarily seen in the middle meatus in anterior rhinoscopy or nasoendoscopy and\u002For\n  * Signs of mucopurulent discharge seen in the nasopharynx or posterior oropharynx and\u002For\n  * Signs of acute maxillary sinusitis is seen in sinus X-rays or CT\u002FCBCT scans and\u002For\n  * Signs of acute maxillary sinusitis seen in the sinus ultrasound\n* No signs of mucosal disease at nasoendoscopy during the asymptomatic period\n* At most, minor signs of inflammation in the maxillary sinuses and\u002For ostiomeatal complex in CT\u002FCBCT scans during the asymptomatic period\n\n  * Maximum 2-3 mm mucosal thickness in maxillary sinus medial and lateral wall\n\nChronic maxillary rhinosinusitis:\n\n* Presence of typical symptoms of chronic rhinosinusitis for equal or longer than 12 weeks\n\n  * 2 or more symptoms, one of which should be either nasal blockage\u002Fobstruction or nasal discharge (anterior\u002Fposterior nasal drip)\n  * +\u002F- facial pain\u002Fpressure\n  * +\u002F- reduction or loss of smell and either\n  * Endoscopic signs of mucopurulent discharge primarily from middle meatus and\u002For\n  * Endoscopic signs of oedema\u002Fmucosal obstruction primarily in middle meatus and\u002For\n  * Inflammatory mucosal changes within the ostiomeatal complex and\u002For sinus in the CT\u002FCBCT scans and the changes are limited mainly into maxillary sinuses (Fokkens et al. 2012)\n\nThe patients are not recruited in the study while they are having an exacerbation of chronic rhinosinusitis or an ongoing acute rhinosinusitis. Neither are the follow-up visits carried out during these episodes but postponed later. This way it can be ensured that the preoperative evaluation and the follow-up evaluation correspond with each other.","69 Years",{"count":52,"type":22},120,[54],"NA","This study is a prospective, randomized, placebo-controlled, double-blinded clinical study. The balloon sinuplasty treatment is compared to placebo effect in chronic or recurrent maxillary sinusitis. The purpose is to find out the efficacy of balloon sinuplasty of maxillary sinuses and the patients who get the best benefit from balloon sinuplasty. The investigators also want to find out if balloon sinuplasty of maxillary sinuses improves Eustachian tube dysfunction. The study is executed in the Department of Ear and Oral Diseases, Tampere University Hospital. 120 patients who have either recurrent acute or chronic rhinosinusitis without nasal polyposis and whose sinusitis is limited mainly into maxillary sinuses, are recruited in the study. The patients are allocated either into the chronic maxillary sinusitis (60 patients) or the recurrent maxillary sinusitis (60 patients) branch of the study. Then, the patients are consecutively randomized into two treatment groups in the proportion of 1 to 1: A) Balloon sinuplasty group and B) Placebo group. The treatment is performed according to the patient's group status and all the patients are followed 12 months postoperatively.\n\nThe effect of balloon sinuplasty treatment in chronic maxillary rhinosinusitis is going to be measured primarily with the Sino-Nasal Outcome Test (SNOT-22). In recurrent acute maxillary rhinosinusitis, the effect of balloon sinuplasty treatment will be measured primarily with the number of acute rhinosinusitis infections. Besides this, number of antibiotic treatments and sick leaves are inquired, Visual Analog Scale (VAS) and Eustachian Tube Dysfunction Questionnaire (ETDQ-7) are used, rhinomanometry, Cone Beam Computed Tomography (CBCT), tympanometry, tubomanometry, nasal endoscopy and general evaluation of the patients clinical ORL-status are performed. Also pre- and postoperative biopsies are taken from the middle turbinates.",[57,28,58,59],"Maxillary Sinusitis","Sinusitis Recurrent","Eustachian Tube Dysfunction",[61],"Balloon sinuplasty","2022-10-18",{"date":64,"type":34},"2022-10-20",{"date":66,"type":34},"2021-06-01",{"date":68,"type":22},"2027-12-31",{"name":70,"class":41},"Tampere University Hospital",1]