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

Tracking Information

• First Submitted Date: June 26, 2006
• First Posted Date: June 27, 2006
• Last Update Posted Date: December 7, 2009
• Study Start Date: April 2006
• Actual Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: October 22, 2008): 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 ]
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures (submitted: October 22, 2008): list of undesirable events [ Time Frame: during the treatment period ]
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Rhinitis

Intervention

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

Study Arms

• Experimental: 1
  Intervention: Drug: triamcinolone acetonide
• Placebo Comparator: 2
  Intervention: Drug: placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: October 22, 2008): 77
• Original Enrollment: Not Provided
• Study Completion Date: Not Provided
• Actual Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT00344942
• Other Study ID Numbers: TRICA_L_00872; EudraCT #: 2006-000059-16
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Medical Affairs Study Director, sanofi-aventis
• Original Responsible Party: Not Provided
• Current Study Sponsor: Sanofi
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: M SEBILLE, Dr; Sanofi

• PRS Account: Sanofi
• Verification Date: December 2009