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

Sanofi

Status and phase

Terminated

Phase 3

Conditions

Rhinitis

Treatments

Drug: placebo

Drug: triamcinolone acetonide

Study type

Interventional

Funder types

Industry

Identifiers

NCT00344942

EudraCT #: 2006-000059-16

TRICA_L_00872

Details and patient eligibility

About

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

Enrollment

77 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.