Trial of Directed High-dose Nasal Steroids on Residual Smell Loss in Sinus Patients After Sinus Surgery

NCT01814618 | Withdrawn Phase 2

• 1 other identifier: 12-1567
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if a trial of directed high-dose nasal steroids improves residual smell loss in patients with chronic rhinosinusitis following sinus surgery. Other outcomes of this study include: identifying the differences in sinus airflow between patients who improve following nasal steroid treatment and those who do not, and to see if, in patients who improve following surgery, the improvement remains throughout follow-up.

Conditions

Olfaction Disorders; Sinusitis; Paranasal Sinus Diseases

Outcome Measures

Primary Outcomes (2)

• Change in Degree of Olfactory Function

  Measurements of smell will be taken at the initial preoperative visit and again at the 4-6 week postoperative visit using the University of Pennsylvania Smell Identification Test (UPSIT) and the Phenyl Ethyl Alcohol (PEA) Threshold test, in which smell is assessed by smelling different concentrations of PEA. The UPSIT is a scratch and sniff test and the PEA threshold testing is a process by which the subject smells vials of different concentrations of odorant (PEA) to determine lowest detectable concentration of odorant.

  4-6 week post-operative visit

• Change in Degree of Olfactory Function

  Measurements of smell will be taken at the initial preoperative visit and again at the 3-4 month postoperative visit using the University of Pennsylvania Smell Identification Test (UPSIT) and the Phenyl Ethyl Alcohol (PEA) Threshold test, in which smell is assessed by smelling different concentrations of PEA. The UPSIT is a scratch and sniff test and the PEA threshold testing is a process by which the subject smells vials of different concentrations of odorant (PEA) to determine lowest detectable concentration of odorant.

  3-4 month post-operative visit

Secondary Outcomes (8)

• Change in Head CT Grade

  4-6 week post-operative visit

• Change in Head CT Grade

  3-4 month post-operative visit

• Change in Nasal Endoscopy Grade

  4-6 week post-operative visit

• Change in Nasal Endoscopy Grade

  3-4 month post-operative visit

• Change in Quality of Life

  4-6 week post-operative visit

Study Arms (2)

Observation

NO INTERVENTION

These subjects did not have improved sense of smell after surgery and were randomized to this observation group or treatment group. These patients will be observed post-operatively but will not receive the trial medication.

Treatment

EXPERIMENTAL

These subjects did not have improved sense of smell after surgery and were randomized to this treatment group or the observation. These patients will be observed post-operatively and will receive a 3-month course of topical nasal steroids(budesonide respules). Drug: Budesonide Respules Other Names: Pulmicort respules Subjects irrigate their noses with budesonide respules. They will use one respule per nostril twice daily for three months.

Drug: Budesonide Respules

Interventions

Budesonide Respules DRUG

Subjects irrigate their noses with budesonide respules. They will use one respule per nostril twice daily for three months.

Also known as: Pulmicort respules

Treatment

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are otherwise healthy undergoing surgery for treatment of chronic rhinosinusitis will be evaluated for olfactory dysfunction, and if present, will be recruited for study participation. The subjects will be included without regard to their gender, race or ethnicity. Subjects will be identified from patients in the clinical practices of the Department of Otolaryngology - Head and Neck Surgery at the University of North Carolina. Only adult patients greater than 18 years old and less than 85 will be approached for this study, as patient treatment algorithms outside this range tend to vary with greater frequency. Due to limited resources, only patients fluent in English will be included, thus minimizing confounding variables and hurdles to patient communication, as some clinics do not have interpreting services. Also, most of the quality of life surveys and olfactory testing do not have non English versions. Only patients with health insurance will be included in the study in order to ensure all participants have access to the study drug.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

UNC Chapel Hill Department of Otolaryngology/Head and Neck Surgery

Chapel Hill, North Carolina, 27514, United States

Location

MeSH Terms

Conditions

Olfaction Disorders; Sinusitis; Paranasal Sinus Diseases

Interventions

Budesonide

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Infections; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Adam M Zanation, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2013
• First Posted: March 20, 2013
• Study Start: March 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: April 6, 2016

Record last verified: 2014-09

Locations

US (1)