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

Rhinitis Clinical Trial

— RhiCNANI  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00344942
• Other study ID #: TRICA_L_00872
• Secondary ID: EudraCT #: 2006-
• Status: Terminated
• Phase: Phase 3
• First received: June 26, 2006
• Last updated: December 4, 2009
• Start date: April 2006

Study information

• Verified date: December 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 77
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Rhinitis

Intervention

Drug:
• triamcinolone acetonide
220µg/day or a double spray into each nostril once daily for 12 weeks'treatment
• placebo
a double spray into each nostril once daily

Locations

Country	Name	City	State
France	Sanofi-Aventis	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	list of undesirable events		during the treatment period	No