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

NCT02877485 | Completed Phase 4 Results FDA Drug

• 1 other identifier: IRB-36535
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasal Obstruction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Nasal Obstruction Symptom Evaluation (NOSE) Score Following Surgery in Subset of Patients Who Elect to Undergo Surgery.

  Postoperative time interval (months): 1-2 , 3-5 , 6-9, 9-12, >12.

Study Arms (2)

Triamcinolone acetonide then Ayr spray

ACTIVE COMPARATOR

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; Drug: Ayr saline nasal mist

Ayr spray then triamcinolone acetonide

ACTIVE COMPARATOR

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; Drug: Ayr saline nasal mist

Interventions

Triamcinolone Acetonide DRUG

2 sprays sprayed to both nostrils daily for 42 days.

Also known as: Nasacort

Ayr spray then triamcinolone acetonide; Triamcinolone acetonide then Ayr spray

Ayr saline nasal mist DRUG

110mcg (2 sprays) sprayed to both nostrils daily for 42 days.

Ayr spray then triamcinolone acetonide; Triamcinolone acetonide then Ayr spray

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Intranasal steroid use within the last three months
• Current systemic steroid use
• Prior septal surgery
• Individuals who are pregnant or actively breastfeeding

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Hospital and Clinics

Stanford, California, 94305, United States

Location

Related Publications (4)

• 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.

  PMID: 23169536 BACKGROUND

• 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.

  PMID: 14990910 BACKGROUND

• 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.

  PMID: 23846399 BACKGROUND

• 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.

  PMID: 26747790 BACKGROUND

MeSH Terms

Conditions

Nasal Obstruction

Interventions

Triamcinolone Acetonide; Triamcinolone

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Limitations and Caveats

The presence and degree of inferior turbinate hypertrophy, the presence of allergic rhinitis, chronic sinusitis, and other forms of nasal mucosal edema, were not assessed or included in analysis.

Results Point of Contact

• Title: Sam P. Most MD
• Organization: Stanford Facial Plastic and Reconstructive Surgery

smost@stanford.edu

650-736-3223

Study Officials

• Sam P Most, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of Facial Plastic and Reconstructive Surgery

Study Record Dates

• First Submitted: August 19, 2016
• First Posted: August 24, 2016
• Study Start: August 1, 2016
• Primary Completion: August 15, 2019
• Study Completion: August 15, 2019
• Last Updated: August 13, 2020
• Results First Posted: August 13, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)