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TerminatedNCT00344942RhiCNANIUpdated Dec 7, 2009

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

A Phase 3 interventional study of triamcinolone acetonide and placebo in Rhinitis, sponsored by Sanofi. Terminated at 1 site in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2009-12-07.

Sponsored by Sanofi · Phase 3, Interventional, and Treatment

Why this study was terminated
patient's recruitment too difficult
Phase
Phase 3
Study type
Interventional
Enrollment
77
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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

02

Conditions studied

  • Rhinitis

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03

In context

Rhinitis

1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.

This study's enrollment of 77 is below the median of 89 across 906 interventional studies indexed under Rhinitis.

Browse Rhinitis studies →

Lead sponsor

Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
77 participants (actual)

Study arms

  • Experimental
    1

    Drug: triamcinolone acetonide

  • Placebo comparator
    2

    Drug: placebo

Interventions

  • Drugtriamcinolone acetonide

    220µg/day or a double spray into each nostril once daily for 12 weeks'treatment

  • Drugplacebo

    a double spray into each nostril once daily

06

What researchers measure

Primary outcomes

  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 outcomes

  1. list of undesirable events

    Time frame: during the treatment period

07

Study locations

1 site
  • Sanofi-Aventis
    Paris, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 7, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00344942
Lead sponsor
Sanofi
First posted
Jun 27, 2006
Start date
Apr 2006
Primary completion
Apr 2007
Last update
Dec 7, 2009

Study contacts

M SEBILLE, Dr
study director · Sanofi

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Dec 2009. You cannot join it, but the record below documents what was studied.

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