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Phase 4 N=42 Randomized Quadruple-blind Treatment

The Effectiveness of Nasal Corticosteroids Versus Placebo in Nasal Obstruction in Patients With Nasal Septal Deviation

Nasal Obstruction

Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcome: Primary: Nasal Obstruction as Measured by Nasal Obstruction Symptom Evaluation (NOSE) Scores Following Therapy With Treatment (Triamcinolone Acetonide) and Placebo (Ayr Saline Spray) — 69.1; 68.5; 65.2; 65.8 score on a scale — p=0.7

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Triamcinolone Acetonide (Drug); Ayr saline nasal mist (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Stanford University
Primary completion
Aug 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
Nasal Obstruction as Measured by Nasal Obstruction Symptom Evaluation (NOSE) Scores Following Therapy With Treatment (Triamcinolone Acetonide) and Placebo (Ayr Saline Spray)
69.1; 68.5; 65.2; 65.8; 64.1; 61.5 0.7
SECONDARY
Nasal Obstruction Symptom Evaluation (NOSE) Score Following Surgery in Subset of Patients Who Elect to Undergo Surgery.
70; 16.2; 17.6; 17.2; 22.2; 20 <0.001 sig

Summary

The purpose of this project is to determine if intranasal corticosteroids have an effect on nasal obstruction in patients with nasal septal deviation.

Eligibility Criteria

Inclusion Criteria

  • Age greater than 18
  • NOSE score greater than 55
  • Nasal septal deviation on exam

Exclusion Criteria

  • Intranasal steroid use within the last three months
  • Current systemic steroid use
  • Prior septal surgery
  • Individuals who are pregnant or actively breastfeeding
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02877485). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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