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

NCT ID: NCT00344942

Last Updated: 2009-12-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30

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

Conditions

Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Group Type: EXPERIMENTAL

triamcinolone acetonide

Intervention Type: DRUG

220µg/day or a double spray into each nostril once daily for 12 weeks'treatment

2

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

a double spray into each nostril once daily

Interventions

triamcinolone acetonide

220µg/day or a double spray into each nostril once daily for 12 weeks'treatment

Intervention Type: DRUG

placebo

a double spray into each nostril once daily

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

sanofi-aventis

Principal Investigators

M SEBILLE, Dr

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis

Paris, , France

Countries

France

Other Identifiers

EudraCT #: 2006-000059-16

Identifier Type: -

Identifier Source: secondary_id

TRICA_L_00872

Identifier Type: -

Identifier Source: org_study_id