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

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ClinicalTrials.gov Identifier: NCT00344942
Recruitment Status : Terminated (patient's recruitment too difficult)
First Posted : June 27, 2006
Last Update Posted : December 7, 2009
Sponsor:
Information provided by:
Sanofi

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

Condition or disease Intervention/treatment Phase
Rhinitis Drug: triamcinolone acetonide Drug: placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : April 2006
Actual Primary Completion Date : April 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: triamcinolone acetonide
220µg/day or a double spray into each nostril once daily for 12 weeks'treatment
Placebo Comparator: 2 Drug: placebo
a double spray into each nostril once daily



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. list of undesirable events [ Time Frame: during the treatment period ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00344942


Locations
France
Sanofi-Aventis
Paris, France
Sponsors and Collaborators
Sanofi
Investigators
Study Director: M SEBILLE, Dr Sanofi

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00344942     History of Changes
Other Study ID Numbers: TRICA_L_00872
EudraCT #: 2006-000059-16
First Posted: June 27, 2006    Key Record Dates
Last Update Posted: December 7, 2009
Last Verified: December 2009

Additional relevant MeSH terms:
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action