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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02877485
Recruitment Status : Completed
First Posted : August 24, 2016
Last Update Posted : November 15, 2019
Sponsor:
Information provided by (Responsible Party):
Sam P. Most, Stanford University

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids

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.




Primary Outcome Measures :
  1. Nasal obstruction as measured by NOSE (Nasal Obstruction Symptom Evaluation) scores following therapy with treatment (triamcinolone acetonide) and placebo (Ayr saline spray) [ Time Frame: 4 months ]

Secondary Outcome Measures :
  1. NOSE score following surgery in subset of patients who elect to undergo, and are medically cleared for, surgery [ Time Frame: 6 months ]


Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02877485


Locations
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United States, California
Stanford Hospital and Clinics
Stanford, California, United States, 94304
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Shannon F Rudy, MD Stanford University
Principal Investigator: Sam P Most, MD Stanford University
Publications:
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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    Key Record Dates
Last Update Posted: November 15, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The investigators plan to analyze and list deidentified patient data, including pre- and post-steroid and placebo NOSE scores, as well as post-surgery NOSE scores, if applicable

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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