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Efficacy and Safety Study of Nasacort in Chronic Non Allergic and Non Infectious Rhinitis in Adults (RhiCNANI)
This study has been terminated.
( patient's recruitment too difficult )
Study NCT00344942   Information provided by Sanofi-Aventis
First Received: June 26, 2006   Last Updated: December 30, 2008   History of Changes

June 26, 2006
December 30, 2008
April 2006
April 2007   (final data collection date for 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 ]
Mean global score obtained on the basis of 5 evaluations : nasal obstruction, rhinorrheoa, disturbed sense of smell, sneezing, facial heaviness.
Complete list of historical versions of study NCT00344942 on ClinicalTrials.gov Archive Site
list of undesirable events [ Time Frame: during the treatment period ] [ Designated as safety issue: No ]
Same as current
 
Efficacy and Safety Study of Nasacort in Chronic Non Allergic and Non Infectious Rhinitis in Adults
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

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

 
Phase III
Interventional
Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Rhinitis
  • Drug: triamcinolone acetonide
  • Drug: placebo
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Terminated
77
 
April 2007   (final data collection date for primary outcome measure)

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.

Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00344942
Medical Affairs Study Director, sanofi-aventis
TRICA-L-00872, EudraCT #: 2006-000059-16
Sanofi-Aventis
 
Study Director: M SEBILLE, Dr Sanofi-Aventis
Sanofi-Aventis
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP