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

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

Detailed Description
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Participants were identified at their initial visit to the Stanford Facial Plastic and Reconstructive Surgery Clinic, an academic referral center, in consultation for nasal obstruction. If eligible and interested in participating, patients provided written informed consent prior to randomization. Eligible participants were patients over the age of 18 years of age with the presence of nasal septal deviation as identified by physical examination, as well as a baseline NOSE score of 35 or greater. Exclusion criteria included a history of nasal or septal surgery, use of intranasal steroids in the three months preceding enrollment, use of systemic steroids in the six months preceding enrollment, and pregnancy or active breastfeeding at the time of enrollment. In order to maximize generalizability of the study, no medications other than systemic and intranasal steroids were used as exclusion criteria. All study participants received 6 weeks of therapy with an intranasal steroid spray, Nasacort (Chattem Inc), which consists of the steroid triamcinolone acetonide, as well as 6 weeks of placebo with Ayr saline spray (B.F. Ascher). These two study drugs were packaged identically by a local pharmacist and labelled Drug A and Drug B. Nasacort was selected as the intranasal steroid following pharmacist consultation, as this intranasal steroid is less scented than others and therefore was less likely to be distinguishable from the placebo to participants. Participants were instructed to use both drugs as follows: 1 spray per nostril twice a day. Researchers, statistical analysts, and study participants were blinded to the identity of the two drugs until the conclusion of the study. A duration of 6 weeks per drug was selected based on the most commonly observed insurance requirements seen in our practice. Following unblinding, it was determined that Drug A was the placebo, the saline spray, and Drug B was the test drug, the nasal steroid. Following completion of both study drugs, patients were offered surgical intervention. If interested and medically cleared for surgery, patients underwent surgery. All surgeries were performed by the senior author and included open septorhinoplasty to address septal deviation, with repair of nasal valve stenosis and inferior turbinate reduction performed in some patients as deemed necessary by the senior author.

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

Conditions
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Nasal Obstruction

Intervention / Treatment
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* Drug: Triamcinolone Acetonide
* Drug: Ayr saline nasal mist


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Triamcinolone acetonide then Ayr spray<br>This study arm will start with 6 weeks of therapy with the intranasal steroid, followed by 6 weeks of therapy with a placebo, with a two week washout period in between treatments. | Drug: Triamcinolone Acetonide<br>* 2 sprays sprayed to both nostrils daily for 42 days.<br>* Other names: Nasacort;Drug: Ayr saline nasal mist<br>* 110mcg (2 sprays) sprayed to both nostrils daily for 42 days.<br>|
| Active Comparator: Ayr spray then triamcinolone acetonide<br>This study arm will start with 6 weeks of placebo, followed by 6 weeks of therapy with the intranasal steroid, with a two week washout period in between treatments. | Drug: Triamcinolone Acetonide<br>* 2 sprays sprayed to both nostrils daily for 42 days.<br>* Other names: Nasacort;Drug: Ayr saline nasal mist<br>* 110mcg (2 sprays) sprayed to both nostrils daily for 42 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nasal Obstruction as Measured by Nasal Obstruction Symptom Evaluation (NOSE) Scores Following Therapy With Treatment (Triamcinolone Acetonide) and Placebo (Ayr Saline Spray) | Nasal Obstruction Symptom Evaluation (NOSE) scale: A quality of life (QOL) instrument developed to assess nasal obstruction symptoms in patients undergoing septoplasty. It consists of a 5-item questionnaire, scored on a 5-point (0-4) Likert scale. The raw score ranges from 0-20, which is scaled to a score of 0-100 by multiplying the raw score by 5, where '0' represents 'no problem' and, and '100' represent 'worst problem.' | Pre-spray NOSE score - 6 weeks Post spray NOSE score- 2 weeks washout - Pre spray Pre-spray NOSE score - 6 weeks Post spray NOSE score | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nasal Obstruction Symptom Evaluation (NOSE) Score Following Surgery in Subset of Patients Who Elect to Undergo Surgery. | Nasal Obstruction Symptom Evaluation (NOSE) scale: A quality of life (QOL) instrument developed to assess nasal obstruction symptoms in patients undergoing septoplasty. It consists of a 5-item questionnaire, scored on a 5-point (0-4) Likert scale. The raw score ranges from 0-20, which is scaled to a score of 0-100 by multiplying the raw score by 5, where '0' represents 'no problem' and, and '100' represent 'worst problem.' | Postoperative time interval (months): 1-2 , 3-5 , 6-9, 9-12, >12. |