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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 )

Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00344942
  Purpose

To demonstrate the superiority of the clinical efficacy of 12 weeks' treatment with Nasacort versus placebo in adult patients pressenting with Chronic Non Allergic and Non Infectious Rhinitis


Condition Intervention Phase
Chronic Non Allergic and Non Infectious Rhinitis
Drug: triamcinolone acetonide
Phase III

ChemIDplus related topics:   Triamcinolone acetonide    Triamcinolone    Triamcinolone diacetate    Triamcinolone hexacetonide   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • Mean global score obtained on the basis of 5 evaluations : nasal obstruction, rhinorrheoa, disturbed sense of smell, sneezing, facial heaviness.

Estimated Enrollment:   270
Study Start Date:   April 2006
Study Completion Date:   August 2007

  Eligibility
Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • patient pressenting 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 pressenting a mean global score for the 5 symptoms >= 5 (nasal obstruction, rhinorrheoa, disturbance of sense of smell, sneezing, facial heaviness), or mean score for the 3 main symptoms (nasal obstruction, rhinorrheoa, disturbance of sense of smell) >= 5 (mean for 7 days prior to visit V0).
  • patient pressenting 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 tumour
  • 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 programme 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 pressenting 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00344942

Locations
France
Sanofi-Aventis    
      Paris, France

Sponsors and Collaborators
Sanofi-Aventis

Investigators
Study Director:     M COUDERC, Dr     Sanofi-Aventis    
  More Information


Study ID Numbers:   TRICA-L-00872, EudraCT #: 2006-000059-16
First Received:   June 26, 2006
Last Updated:   July 18, 2008
ClinicalTrials.gov Identifier:   NCT00344942
Health Authority:   France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:
Triamcinolone Acetonide
Otorhinolaryngologic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Triamcinolone
Triamcinolone diacetate
Rhinitis
Triamcinolone hexacetonide

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Therapeutic Uses
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Enzyme Inhibitors
Immunosuppressive Agents
Hormones
Glucocorticoids
Pharmacologic Actions
Nose Diseases

ClinicalTrials.gov processed this record on October 10, 2008




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