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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by University of North Carolina, Chapel Hill
Sponsor:
Information provided by (Responsible Party):
Adam Zanation, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01814618
First received: March 18, 2013
Last updated: NA
Last verified: March 2013
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Olfaction Disorders
Sinusitis
Paranasal Sinus Diseases
Drug: Budesonide Respules
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Trial of Directed High-dose Nasal Steroids on Residual Olfactory Dysfunction in Patients With Chronic Rhinosinusitis Following Endoscopic Sinus Surgery

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Change in Degree of Olfactory Function [ Time Frame: 4-6 week post-operative visit ] [ Designated as safety issue: No ]
    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.

  • Change in Degree of Olfactory Function [ Time Frame: 3-4 month post-operative visit ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change in Head CT Grade [ Time Frame: 4-6 week post-operative visit ] [ Designated as safety issue: No ]
    A head CT will be performed at the initial preoperative visit and at the 4-6 week post-operative visit. The head CT will be assessed using the Lund-Mackay scoring system, in which physician graders will analyze the CT for abnormalities in the patient's sinuses and nasal cavity.

  • Change in Head CT Grade [ Time Frame: 3-4 month post-operative visit ] [ Designated as safety issue: No ]
    Subjects in the "non-improved" arm (regardless of whether they were randomized to receive nasal steroids) will receive a head CT at this time point. The CT will be assessed using the Lund-Mackay scoring system, in which physician graders will analyze the CT for abnormalities in the patient's sinuses and nasal cavity.

  • Change in Nasal Endoscopy Grade [ Time Frame: 4-6 week post-operative visit ] [ Designated as safety issue: No ]
    Nasal endoscopy will be performed at the initial preoperative visit and again at the 4-6 week postoperative visit. The nasal cavity and sinuses will be assessed using the Lund-Kennedy scoring method which addresses crusting, scarring, edema, discharge, and presence of polyps.

  • Change in Nasal Endoscopy Grade [ Time Frame: 3-4 month post-operative visit ] [ Designated as safety issue: No ]
    Nasal endoscopy will be performed at the initial preoperative visit and at the 3-4 month postoperative visit. The nasal cavity and sinuses will be assessed using the Lund-Kennedy scoring method which addresses crusting, scarring, edema, discharge, and presence of polyps.

  • Change in Quality of Life [ Time Frame: 4-6 week post-operative visit ] [ Designated as safety issue: No ]
    Quality of life will be assessed at the initial preoperative visit as well as the 4-6 week postoperative visit using the Sinonasal Outcome Test 22(SNOT-22) and the Rhinosinusitis Outcome Measure 31 (RSOM-31). The Snot-22 and RSOM-31 are questionnaires used to measure disease related quality of life and symptoms.

  • Change in Quality of Life [ Time Frame: 3-4 month post-operative visit ] [ Designated as safety issue: No ]
    Quality of life will be assessed at the initial preoperative visit as well as the 3-4 month postoperative visit using the Sinonasal Outcome Test 22(SNOT-22) and the Rhinosinusitis Outcome Measure 31 (RSOM-31). The Snot-22 and RSOM-31 are questionnaires used to measure disease related quality of life and symptoms.

  • Number of patients with steroid side effects after a 1-2 week course of steroids [ Time Frame: 5-8 weeks post-operatively ] [ Designated as safety issue: Yes ]
    Subjects who were randomized to the treatment arm will be contacted by phone 1-2 weeks after starting steroids and will review a pre-constructed medication safety and side effect questionnaire with the caller. Patients will also be asked to review their medication diary with the caller.

  • Number of patients with steroid side effects after a 8 week course of steroids [ Time Frame: 3-4 month post-operative visit ] [ Designated as safety issue: Yes ]
    Subjects who were randomized to the treatment arm will return to clinic 3-4 months postoperatively and medication diaries will be reviewed and assessed for compliance and concerning side effects. These diaries will be collected for future review by the independent data safety reviewer.


Estimated Enrollment: 70
Study Start Date: March 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Observation
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.
Experimental: Treatment

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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 84 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • If the patient is a premenopausal woman, she will be asked if she is pregnant or breastfeeding. If she is either of these, she will be excluded from the study. All remaining women will receive a urine pregnancy test. If this urine pregnancy test is positive, the patient will be excluded from the study. Thus, for premenopausal female patients, a negative urine pregnancy test is necessary for inclusion in the study because of the need for repeat CTs and the possible systemic manifestations due to steroid irrigation. Further exclusion criteria will include the following: hypersensitivity to cortisol, history of pituitary disease, and allergic disease with subsequent anaphylaxis or breathing difficulties. Additionally, patients with a history of immunodeficiency, autoimmune disease, cystic fibrosis, or previous sinus surgery will be excluded as these co-morbidities might cloud the relationship between the treatment and the outcome.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01814618

Contacts
Contact: Emily Cohn, BSPH 919-843-7157 emily_cohn@med.unc.edu
Contact: Justin Miller, BSPH 910-695-8179 justin_miller@med.unc.edu

Locations
United States, North Carolina
UNC Chapel Hill Department of Otolaryngology/Head and Neck Surgery Recruiting
Chapel Hill, North Carolina, United States, 27514
Principal Investigator: Adam Zanation, MD         
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Adam M Zanation, MD University of North Carolina, Chapel Hill
  More Information

No publications provided

Responsible Party: Adam Zanation, MD, Assistant Professor of Otolaryngology/Head and Neck Surgery, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01814618     History of Changes
Other Study ID Numbers: 12-1567
Study First Received: March 18, 2013
Last Updated: March 18, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Olfaction Disorders
Paranasal Sinus Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Budesonide
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 18, 2014