ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Efficacy and Safety Study of Nasacort in Chronic Non Allergic and Non Infectious Rhinitis in Adults (RhiCNANI)

This study has been terminated.
Study NCT00344942.   Last updated on October 22, 2008.   Information provided by Sanofi-Aventis

This Tabular View shows the required WHO registration data elements as marked by

Descriptive Information Fields
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
Study Phase Phase III
Study Type  Interventional
Study Design  Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure  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 ] [ Designated as safety issue: No ]
Secondary Outcome Measure  list of undesirable events [ Time Frame: during the treatment period ] [ Designated as safety issue: No ]
Condition  Rhinitis
Intervention  Drug: triamcinolone acetonide
Drug: placebo
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Terminated
Enrollment  77
Start Date  April 2006
Completion Date
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.

Gender Both
Ages 18 Years to 65 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries  France
Administrative Information Fields
NCT ID  NCT00344942
Organization ID TRICA-L-00872
Secondary IDs †† EudraCT #: 2006-000059-16
Study Sponsor  Sanofi-Aventis
Collaborators ††
Investigators 
Study Director:     M SEBILLE, Dr     Sanofi-Aventis    
Information Provided By Sanofi-Aventis
Verification Date October 2008
First Received Date  June 26, 2006
Last Updated Date October 22, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




Links to all studies - primarily for crawlers