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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00344942
• Date of registration: 26/06/2006
• Prospective Registration: No
• Primary sponsor: Sanofi
• Public title: Efficacy and Safety Study of Nasacort in Chronic Non Allergic and Non Infectious Rhinitis in Adults RhiCNANI
• Scientific 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
• Date of first enrolment: April 2006
• Target sample size: 77
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00344942
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

France

Contacts

• Name: M SEBILLE, Dr
• Affiliation: Sanofi

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Rhinitis

Intervention(s)

Drug: placebo

Drug: triamcinolone acetonide

Primary Outcome(s)

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]

Secondary Outcome(s)

list of undesirable events [Time Frame: during the treatment period]

Secondary ID(s)

EudraCT #: 2006-000059-16

TRICA_L_00872

Source(s) of Monetary Support

Please refer to primary and secondary sponsors