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

Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rhinitis

Intervention: triamcinolone acetonide (Drug); placebo (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Sanofi

Official(s) and/or principal investigator(s):
M SEBILLE, Dr, Study Director, Affiliation: Sanofi


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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

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

Secondary outcome: list of undesirable events


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


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


- 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.

Locations and Contacts

Sanofi-Aventis, Paris, France
Additional Information

Starting date: April 2006
Last updated: December 4, 2009

Page last updated: August 23, 2015

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