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

Primary Purpose

Rhinitis

Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
triamcinolone acetonide
placebo
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rhinitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sanofi-Aventis

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Mean global score obtained on the basis of 5 evaluations : nasal obstruction, rhinorrhea, disturbed sense of smell, sneezing, facial heaviness.

Secondary Outcome Measures

list of undesirable events

Full Information

First Posted
June 26, 2006
Last Updated
December 4, 2009
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00344942
Brief Title
Efficacy and Safety Study of Nasacort in Chronic Non Allergic and Non Infectious Rhinitis in Adults
Acronym
RhiCNANI
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 Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Terminated
Why Stopped
patient's recruitment too difficult
Study Start Date
April 2006 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
triamcinolone acetonide
Intervention Description
220µg/day or a double spray into each nostril once daily for 12 weeks'treatment
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
a double spray into each nostril once daily
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
list of undesirable events
Time Frame
during the treatment period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M SEBILLE, Dr
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis
City
Paris
Country
France

12. IPD Sharing Statement

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

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