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

Phase 3

Terminated

• Conditions: Rhinitis
• Interventions: Drug: triamcinolone acetonide; Drug: placebo

• Registration Number: NCT00344942
• Lead Sponsor: Sanofi

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2006-06-26
• Study First Submitted QC: 2006-06-26
• Study First Posted: 2006-06-27
• Primary Completion: 2007-04
• Status Verified: 2009-12
• Last Update Submitted: 2009-12-04
• Last Update Posted: 2009-12-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 77

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	triamcinolone acetonide	-
2	placebo	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
list of undesirable events	during the treatment period

Trial Locations

Locations (1)

Sanofi-Aventis; 🇫🇷 Paris, France