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)
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00344942
First received: June 26, 2006
Last updated: December 4, 2009
Last verified: December 2009
  Purpose

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 Intervention Phase
Rhinitis
Drug: triamcinolone acetonide
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 Measures:
  • list of undesirable events [ Time Frame: during the treatment period ] [ Designated as safety issue: No ]

Enrollment: 77
Study Start Date: April 2006
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

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
Study First Received: June 26, 2006
Last Updated: December 4, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014