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
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
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
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Locations and Contacts
Sanofi-Aventis, Paris, France
Additional Information
Starting date: April 2006
Last updated: December 4, 2009
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