Clinical trial NCT00344942: Efficacy and Safety Study of Nasacort in Chronic Non Allergic and Non Infectious Rhinitis in Adults
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Rhinitis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-06-27
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Mean global score obtained on the basis of 5 evaluations : nasal obstruction, rhinorrhea, disturbed sense of smell, sneezing, facial heaviness.
timeFrame: 7 days prior to each visit
Secondary outcomes:
measure: list of undesirable events
timeFrame: during the treatment period
Other outcomes:
Locations:
city: Paris
country: France
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: M SEBILLE, Dr
role: STUDY_DIRECTOR
References: