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NCT03317015: NASANIF
A Study to Assess Efficacy and Safety of Nasacort® Nasal Spray in Comparison With Flixonase® Nasal Spray in Adults Suffering From Perennial Allergic Rhinitis (PAR)
Phase 3 trial testing triamcinolone XRG5029 in Rhinitis Allergic in 260 participants. Completed in 10 July 2017.
10 July 2017
Quick facts
| Lead sponsor | Sanofi |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 260 |
| Start date | 30 November 2016 |
| Primary completion | 10 July 2017 |
| Estimated completion | 10 July 2017 |
Drugs / interventions tested
- triamcinolone XRG5029 — full drug profile →
- fluticasone
Conditions studied
- Rhinitis Allergic — all drugs for Rhinitis Allergic →
Sponsor
Sanofi — full company profile →
Who can join
Adults 18 to 50, any sex, with Rhinitis Allergic. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Primary Objective: * To assess efficacy of Nasacort® (triamcinolone) nasal spray, 55 µg per dose, in comparison with Flixonase® (fluticasone) nasal spray, 50 µg per dose, by reflective total nasal symptom score (rTNSS) (24 h) after 28 days of treatment compared with baseline (0 day of treatment) in adult patients suffering from PAR (perennial allergic rhinitis). Secondary Objectives: * To evaluate safety of Nasacort® (triamcinolone) nasal spray, in comparison with Flixonase® (fluticasone) administered for 28 days by assessment of adverse events reports. * To evaluate patient and physician satisfaction after 28 days of treatment by 5-point scale. * To estimate improvement of quality of life during the study by mini Rhinoconjunctivitis Quality of Life Questionnaire (miniRQLQ).
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Triamcinolone Acetonide versus Fluticasone Propionate in the Treatment of Perennial Allergic Rhinitis: A Randomized, Parallel-Group Trial.
Karaulov AV, Vylegzhanina T, Ovchinnikov A, Chernikova M, et al · · 2019 · cited 8× · PMID 30879006 · DOI 10.1159/000497160 -
Triamcinolone Acetonide in the Treatment of Perennial Allergic Rhinitis: A post hoc Analysis of Quality of Life during a Phase III Study.
Karaulov AV, Nenasheva N, Smolkin Y, Maslakov A, et al · · 2022 · cited 3× · PMID 34515149 · DOI 10.1159/000518753 -
Triamcinolone Acetonide in the Treatment of Perennial Allergic Rhinitis: A post hoc Efficacy Analysis of a Phase III Study Performed in Russia.
Karaulov AV, Ilina NI, Shartanova N, Maslakov A, et al · · 2022 · cited 2× · PMID 34535609 · DOI 10.1159/000518754
Verify or expand the search:
- PubMed search for NCT03317015
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Rhinitis Allergic
Currently open trials in the same condition.
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Other Sanofi trials
Trials by the same sponsor.
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- NCT07222189 — A Study to Investigate the Long-term Safety, Tolerability and Efficacy of Balinatunfib in Participants With Crohn's Dise · Phase 2 · not yet recruiting
- NCT07484230 — A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Adult Japanese Partic · Phase 3 · not yet recruiting
- NCT07547436 — A Study to Access Activity and Safety With SAR445399 Compared With Placebo in Participants Aged 18 to 80 Years of Age Wi · Phase 2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03317015 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sanofi
- Last refreshed: 25 April 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03317015.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing