Benefits of the Use of Botox in the Treatment of Empty Nose Syndrome Syndrome - Full Text View

Sponsor:	Mayo Clinic
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00732680

Purpose

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.

Condition	Intervention
Empty Nose Syndrome Atrophic Rhinitis	Drug: Botox

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Prospective Case Series Evaluating Short and Long Term Benefits of the Use of Botox in the Treatment of Empty Nose Syndrome

Resource links provided by NLM:

MedlinePlus related topics: Botox

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

The endpoints will include the patient questionnaire scores 2 months post-intervention (Snot 22 score, SF36, and IES R scores) and rhinomanometry measurements. [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	42
Study Start Date:	December 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Botox: Experimental Treatment will be in the form of 10 Units of Botox type A injected into the dilator nasalis muscle on each side of the nose along with adjunctive measures used in the control phase.	Drug: Botox Treatment will be in the form of 10 Units of Botox type A injected into the dilator nasalis muscle on each side of the nose along with adjunctive measures used in the control phase.

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

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00732680

Contacts

Contact: Nicole Tombers	507-538-1392	tombers.nicole@mayo.edu
Contact: Ahmed Younes, MD	507-538-1392	younes.ahmed@mayo.edu

Locations

United States, Minnesota
Mayo Clinic	Recruiting
Rochester, Minnesota, United States, 55904
Sub-Investigator: Nicole Tombers
Sub-Investigator: Rizwan Siwani, MBBS
Sub-Investigator: Ahmed Younes, MD

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator:

Oren Friedman, M.D.

Mayo Clinic

More Information

Additional Information:

Online listing of the study with study details and contact information. This link exits the ClinicalTrials.gov site

FDA website. Great website for information on Botox. This link exits the ClinicalTrials.gov site

Information on Botox from the US Food and Drug Administration. This link exits the ClinicalTrials.gov site

online blog of people with empty nose syndrome. This link exits the ClinicalTrials.gov site

Mayo Clinic Clinical Trials This link exits the ClinicalTrials.gov site

Publications:

Moore EJ, Kern EB. Atrophic rhinitis: a review of 242 cases. Am J Rhinol. 2001 Nov-Dec;15(6):355-61. Review.

Responsible Party:	Mayo Clinic ( Oren Friedman M.D. )
Study ID Numbers:	08-005015
Study First Received:	August 8, 2008
Last Updated:	December 4, 2009
ClinicalTrials.gov Identifier:	NCT00732680 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Mayo Clinic:

Empty nose syndrome
Over resection of turbinate
Atrophic rhinitis

Additional relevant MeSH terms:

Rhinitis, Atrophic
Otorhinolaryngologic Diseases
Disease
Physiological Effects of Drugs
Rhinitis
Neuromuscular Agents
Pharmacologic Actions

Nose Diseases
Pathologic Processes
Respiratory Tract Diseases
Respiratory Tract Infections
Syndrome
Peripheral Nervous System Agents
Botulinum Toxin Type A

ClinicalTrials.gov processed this record on February 08, 2010