| Efficacy and Safety Study of Nasacort in Chronic Non Allergic and Non Infectious Rhinitis in Adults |
| 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 |
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 |
|
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Mean global score obtained on the basis of 5 evaluations : nasal obstruction, rhinorrhea, disturbed sense of smell, sneezing, facial heaviness. [ Time Frame: 7 days prior to each visit ] [ Designated as safety issue: No ] |
| list of undesirable events [ Time Frame: during the treatment period ] [ Designated as safety issue: No ] |
| Rhinitis |
Drug: triamcinolone acetonide
Drug: placebo |
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|
|
| Terminated |
| 77 |
| April 2006 |
|
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. |
| Both |
| 18 Years to 65 Years |
| No |
|
| France |
|
| NCT00344942 |
| TRICA-L-00872 |
| EudraCT #: 2006-000059-16 |
| Sanofi-Aventis |
|
| Study Director: |
M SEBILLE, Dr |
Sanofi-Aventis |
|
|
| Sanofi-Aventis |
| October 2008 |
| June 26, 2006 |
| October 22, 2008 |