Official Title: “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 pressenting with Chronic Non Allergic and Non Infectious Rhinitis

Study Type: Interventional

Study Design: Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: triamcinolone acetonide

Primary Measures

• Mean global score obtained on the basis of 5 evaluations : nasal obstruction, rhinorrheoa, disturbed sense of smell, sneezing, facial heaviness.

Inclusion Criteria:

• patient pressenting 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 pressenting a mean global score for the 5 symptoms >= 5 (nasal obstruction, rhinorrheoa, disturbance of sense of smell, sneezing, facial heaviness), or mean score for the 3 main symptoms (nasal obstruction, rhinorrheoa, disturbance of sense of smell) >= 5 (mean for 7 days prior to visit V0).
• patient pressenting 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 tumour
• 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 programme 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 pressenting 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Sanofi-Aventis

Overall Clinical Trial Officials and Contacts

M COUDERC, Dr Study Director Sanofi-Aventis  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00344942

Study ID Number: TRICA-L-00872

ClinicalTrials.gov Identifier: NCT00344942

Health Authority: France: Afssaps - French Health Products Safety Agency