Efficacy and Safety Study of Nasacort in Chronic Non Allergic and Non Infectious Rhinitis in Adults

Study Overview
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Brief Summary
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To demonstrate the superiority of the clinical efficacy of 12 weeks' treatment with Nasacort versus placebo in adult patients presenting with Chronic Non Allergic and Non Infectious Rhinitis

Official Title
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A Randomised, Double-blind, French Multi-centre Study, to Evaluate the Efficacy and Tolerance, in Comparison With Placebo, of Nasacort in Chronic Non Allergic and Non Infectious Rhinitis in Adults

Conditions
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Rhinitis

Intervention / Treatment
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* Drug: triamcinolone acetonide
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient presenting with Chronic Non Allergic and Non Infectious Rhinitis capable of benefiting from corticosteroid therapy administered via the nasal route. patient with chronic rhinitis of minimum duration 12 weeks, whether or not consecutive, per year. patient with Non Allergic Rhinitis confirmed by negative phadiatop test. patient presenting a mean global score for the 5 symptoms >= 5 (nasal obstruction, rhinorrhea, disturbance of sense of smell, sneezing, facial heaviness), or mean score for the 3 main symptoms (nasal obstruction, rhinorrhea, disturbance of sense of smell) >= 5 (mean for 7 days prior to visit V0). patient presenting an inflammation score at anterior rhinoscopy or nasal endoscopy >= 4. Exclusion Criteria: patient presenting a nasal polyp patient presenting a severe septal deviation which would interfere with insertion of the nasal spray patient presenting a nasal cavity tumor patient presenting a sinus infection patient presenting a history of endonasal surgery patient presenting a chronic rhinitis of extrinsic origin (drug-related or food-related rhinitis) or intrinsic origin (hormonal rhinitis, positional rhinitis,atrophic rhinitis, ...) patient on a program of intensive sports training patient presenting with : cystic fibrosis, pulmonary mycosis, necrotising vascularitis, immotile cilia syndrome, .... patient presenting with known immunosuppression, lymphoma patient presenting with a known cardiovascular, neurological or other medically significant illness patient presenting with known renal failure, with known glaucoma, with known drug addiction current antibiotic therapy corticosteroids administered in the two months prior to admission patient presenting problems of haemostasis (epistaxis), ophthalmic and/or oro-bucco-nasal herpetic infection. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: triamcinolone acetonide<br>* 220µg/day or a double spray into each nostril once daily for 12 weeks'treatment<br>|
| Placebo Comparator: 2<br> | Drug: placebo<br>* a double spray into each nostril once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean global score obtained on the basis of 5 evaluations : nasal obstruction, rhinorrhea, disturbed sense of smell, sneezing, facial heaviness. |  | 7 days prior to each visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| list of undesirable events |  | during the treatment period |