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

• ClinicalTrials.gov Identifier: NCT02877485
• Recruitment Status: Completed
• First Posted: August 24, 2016
• Results First Posted: August 13, 2020
• Last Update Posted: August 13, 2020
• Sponsor: Stanford University
• Information provided by (Responsible Party): Sam P. Most, Stanford University

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Nasal Obstruction	Drug: Triamcinolone Acetonide; Drug: Ayr saline nasal mist	Phase 4

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Effectiveness of Nasal Corticosteroids Versus Placebo in Nasal Obstruction in Patients With Nasal Septal Deviation
• Actual Study Start Date: August 2016
• Actual Primary Completion Date: August 15, 2019
• Actual Study Completion Date: August 15, 2019

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Triamcinolone acetonide then Ayr spray; 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; 2 sprays sprayed to both nostrils daily for 42 days.; Other Name: Nasacort; Drug: Ayr saline nasal mist; 110mcg (2 sprays) sprayed to both nostrils daily for 42 days.
Active Comparator: Ayr spray then triamcinolone acetonide; 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; 2 sprays sprayed to both nostrils daily for 42 days.; Other Name: Nasacort; Drug: Ayr saline nasal mist; 110mcg (2 sprays) sprayed to both nostrils daily for 42 days.

Outcome Measures

Primary Outcome Measures :

1. Nasal Obstruction as Measured by Nasal Obstruction Symptom Evaluation (NOSE) Scores Following Therapy With Treatment (Triamcinolone Acetonide) and Placebo (Ayr Saline Spray) [ Time Frame: 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 ]

   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.'

Secondary Outcome Measures :

1. Nasal Obstruction Symptom Evaluation (NOSE) Score Following Surgery in Subset of Patients Who Elect to Undergo Surgery. [ Time Frame: Postoperative time interval (months): 1-2 , 3-5 , 6-9, 9-12, >12. ]

   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.'

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 100 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, California

Stanford Hospital and Clinics

Stanford, California, United States, 94305

Sponsors and Collaborators

Stanford University

Investigators

• Principal Investigator: Sam P Most, MD; Stanford University

  Study Documents (Full-Text)

Documents provided by Sam P. Most, Stanford University:

Informed Consent Form  [PDF] May 24, 2019

Study Protocol and Statistical Analysis Plan  [PDF] April 13, 2016

More Information

Publications:

Sedaghat AR, Busaba NY, Cunningham MJ, Kieff DA. Clinical assessment is an accurate predictor of which patients will need septoplasty. Laryngoscope. 2013 Jan;123(1):48-52. doi: 10.1002/lary.23683. Epub 2012 Nov 20.

Stewart MG, Witsell DL, Smith TL, Weaver EM, Yueh B, Hannley MT. Development and validation of the Nasal Obstruction Symptom Evaluation (NOSE) scale. Otolaryngol Head Neck Surg. 2004 Feb;130(2):157-63. doi: 10.1016/j.otohns.2003.09.016.

Lipan MJ, Most SP. Development of a severity classification system for subjective nasal obstruction. JAMA Facial Plast Surg. 2013 Sep-Oct;15(5):358-61. doi: 10.1001/jamafacial.2013.344.

Teti VP, Akdagli S, Most SP. Cost-effectiveness of Corticosteroid Nasal Spray vs Surgical Therapy in Patients With Severe to Extreme Anatomical Nasal Obstruction. JAMA Facial Plast Surg. 2016 May 1;18(3):165-70. doi: 10.1001/jamafacial.2015.2039.

• Responsible Party: Sam P. Most, Chief, Division of Facial Plastic and Reconstructive Surgery, Stanford University
• ClinicalTrials.gov Identifier: NCT02877485
• Other Study ID Numbers: IRB-36535
• First Posted: August 24, 2016
• Results First Posted: August 13, 2020
• Last Update Posted: August 13, 2020
• Last Verified: August 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Nasal Obstruction; Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Immunosuppressive Agents; Immunologic Factors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action