The Effectiveness of Nasal Corticosteroids Versus Placebo in Nasal Obstruction in Patients With Nasal Septal Deviation
Phase: PHASE4
Conditions: Nasal Obstruction
Sponsor: Stanford University

The Effectiveness of Nasal Corticosteroids versus 
Placebo in Nasal Obstruction in Patients with Severe 
Nasal Septal Deviation 
 
 
 
 
 
NCT02877485 
 
 
 
April 13, 2016 
 
 
 
 
 
 
 
 
 
 

Study Protocol  
 
Background:  Nasal septal deviation is a common cause of nasal obstruction, a symptom that 
can have a significant effect on a patient's quality of life. Insurance companies often require 
patients to try a >/=6 weeks treatment course with nasal steroids prior to covering nasal surgery. 
This is true even in cases of physician-documented severe or extreme anatomic nasal obstruction 
that have low likelihood of responding to medical therapy.  
 
Purpose: This study will seek to determine if there is any benefit of intranasal steroids in 
decreasing nasal obstruction in patients with severe or extreme septal deviation compared to 
placebo therapy with intranasal saline spray. 
 
Study Population: Individuals who are over the age of 18 with severe or extreme nasal septal 
deviation. 
Exclusion Criteria: Intranasal steroid use within the last three months; current systemic steroid 
use; prior septal surgery; individuals who are pregnant or actively breastfeeding 
 
Study Design: Randomized, double blind controlled crossover trial 
 
Sample size : To detect a 20% difference in NOSE scores with 80% power and a  2-sided alpha 
level of 0.05 required 20 participants per study group, for a total of 40 participants. 
 
Statistical Analysis: Statistical analyses were performed using IBM SPSS version 26 (IBM 
Corp., Armonk, NY, USA).  
1) Independent t-tests will be used to assess differences in mean NOSE scores when comparing 
the two study groups, p<0.05 deemed statistically significant.  
2) Paired t-tests were used to assess differences in mean NOSE scores after saline use, steroid 
use, and at various post-operative time points compared to the patient’s own baseline NOSE 
score. 
Methods: Please see attached page for flow chart of the study protocol 
 
STUDY DESIGN FLOWCHART: 
  
   
Nasal Obstruction Symptom Evaluation (NOSE) Questionnaire and 
Physical Exam  

 
  
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Group 1:  
Start with 6 weeks 
of Nasacort  
Group 2:  
Start with 6 weeks  
Placebo 
NOSE Questionnaire 
+  2 weeks washout w/ 
no therapy  
  6 weeks of Placebo 
 6 weeks of 
Nasacort  
NOSE Questionnaire 
NOSE Questionnaire 
+  2 weeks washout w/ 
no therapy  
NOSE Questionnaire 
  Option to Undergo Nasal 
Septal Surgery (based on 
participant preference and 
medical clearance for 
surgery) 
If Yes, NOSE Questionnaires 
at 5 postoperative periods. 
This marks the end of the 
study  
If No, final NOSE 
Questionnaire one month 
following completion of 
medial therapy. This marks 
the end of the study