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

August 11, 2020 updated by: Sam P. Most, Stanford University
The purpose of this project is to determine if intranasal corticosteroids have an effect on nasal obstruction in patients with nasal septal deviation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford Hospital and Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 98 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Nasacort
Drug: Ayr saline nasal mist
110mcg (2 sprays) sprayed to both nostrils daily for 42 days.

What is the study measuring?

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: SAM P Most, MD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2016

Primary Completion (Actual)

August 15, 2019

Study Completion (Actual)

August 15, 2019

Study Registration Dates

First Submitted

August 19, 2016

First Submitted That Met QC Criteria

August 23, 2016

First Posted (Estimate)

August 24, 2016

Study Record Updates

Last Update Posted (Actual)

August 13, 2020

Last Update Submitted That Met QC Criteria

August 11, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-36535

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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