Benefits of the Use of Botox in the Treatment of Empty Nose Syndrome Syndrome
Information source: Mayo Clinic
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Empty Nose Syndrome; Atrophic Rhinitis
Intervention: Botox (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Mayo Clinic Official(s) and/or principal investigator(s):
Oren Friedman, M.D., Principal Investigator, Affiliation: Mayo Clinic
Overall contact:
Nicole Tombers, Phone: 507-538-1392, Email: tombers.nicole@mayo.edu
Summary
Empty Nose Syndrome patients suffer from disabling physical symptoms and considerable
distress. To date there is no definitive cure for these symptoms. Established treatment
modalities include saline irrigation, surgical implantation of materials or simply use of
cotton wads/ silicon cones to simulate the resistive action to airflow of the resected
turbinates.
With this study, we will determine the effectiveness of a new treatment modality in the
treatment of Empty Nose Syndrome. This novel treatment method involves the use of Botox.
Clinical Details
Official title: Prospective Case Series Evaluating Short and Long Term Benefits of the Use of Botox in the Treatment of Empty Nose Syndrome
Study design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: The endpoints will include the patient questionnaire scores 2 months post-intervention (Snot 22 score, SF36, and IES R scores) and rhinomanometry measurements.
Detailed description:
Background:
Empty Nose Syndrome (ENS) is the term used to describe the condition resulting from over
resection of nasal turbinate. Symptoms include depression, dysosmia, bleeding, discharge,
crusting, dryness, dysosmia, and pain.
Treatment modalities include adjunctive comfort measures (primarily irrigation), mechanical
measures (Silicon cones, cotton wads) and surgical treatment (alloderm implants, plasti-pore
cartilage grafts etc.) We will investigate a new method of treatment for ENS. This will
involve injection of Botox Type A into the dilator nasalis muscle thus collapsing the
internal nasal valve to provide added resistance to air flow.
Objective:
To evaluate effectiveness of Botox in improving overall QoL in patients.
Methods:
42 subjects will undergo treatment with Botox and adjunctive measures that will involve the
use of saline irrigation alongwith sesame oil amongst other measures.
Before and after treatment data will be obtained in the form of a breathing test and patient
questionnaires that will help us measure changes in physical and mental health (using the
sinonasal outcome test questionnaire or SNOT 22, the short form health survey 36 item
questionnaire, and the Impact of events revised scale).
Conclusion:
We anticipate that Botox application in ENS patients improve overall QoL in these subjects.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Any patient aged 18-65 years of age presenting with a known diagnosis of ENS who has
no known allergies to Botox.
Exclusion Criteria:
- Patients younger than 18 years or older than 65 years of age.
- Patients with neuromuscular disorders or neuropathic diseases.
- Patients with infection and or swelling at the site where Botox is to be injected.
- Patients with known hypersensitivity to any ingredient in the drug formulation
(botulinum toxin, human albumin)
- Patients who are or plan to become pregnant within the time period in which the study
will be conducted.
- Patients who are nursing
Locations and Contacts
Nicole Tombers, Phone: 507-538-1392, Email: tombers.nicole@mayo.edu
Mayo Clinic, Rochester, Minnesota 55904, United States; Recruiting
Nicole Tombers, Sub-Investigator
Rizwan Siwani, MBBS, Sub-Investigator
Ahmed Younes, MD, Sub-Investigator
Additional Information
Online listing of the study with study details and contact information. FDA website. Great website for information on Botox. Information on Botox from the US Food and Drug Administration. online blog of people with empty nose syndrome. Mayo Clinic Clinical Trials
Related publications: Moore EJ, Kern EB. Atrophic rhinitis: a review of 242 cases. Am J Rhinol. 2001 Nov-Dec;15(6):355-61. Review.
Starting date: December 2008
Ending date: December 2009
Last updated: June 5, 2009
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