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

• ClinicalTrials.gov Identifier: NCT00344942
• Recruitment Status: Terminated
• First Posted: June 27, 2006
• Last Update Posted: December 7, 2009
• Sponsor: Sanofi
• Information provided by: Sanofi

Study Description

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

Condition or disease	Intervention/treatment	Phase
Rhinitis	Drug: triamcinolone acetonide; Drug: placebo	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 77 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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 Start Date: April 2006
• Actual Primary Completion Date: April 2007

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1	Drug: triamcinolone acetonide; 220µg/day or a double spray into each nostril once daily for 12 weeks'treatment
Placebo Comparator: 2	Drug: placebo; a double spray into each nostril once daily

Outcome Measures

Primary Outcome Measures :

1. 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 Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

France

Sanofi-Aventis

Paris, France

Sponsors and Collaborators

Sanofi

Investigators

• Study Director: M SEBILLE, Dr; Sanofi

More Information

• Responsible Party: Medical Affairs Study Director, sanofi-aventis
• ClinicalTrials.gov Identifier: NCT00344942
• Other Study ID Numbers: TRICA_L_00872; EudraCT #: 2006-000059-16
• First Posted: June 27, 2006
• Last Update Posted: December 7, 2009
• Last Verified: December 2009

Additional relevant MeSH terms:

Rhinitis; Respiratory Tract Infections; Infections; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Immunosuppressive Agents; Immunologic Factors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action