Benefits of the Use of Botox in the Treatment of Empty Nose Syndrome Syndrome

Atrophic Rhinitis Clinical Trial

Official title:

Prospective Case Series Evaluating Short and Long Term Benefits of the Use of Botox in the Treatment of Empty Nose Syndrome

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00732680
• Other study ID #: 08-005015
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: August 8, 2008
• Last updated: December 30, 2013
• Start date: December 2008
• Est. completion date: November 2009

Study information

• Verified date: December 2013
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

This study will research the effectiveness of a new treatment modality in the treatment of Empty Nose Syndrome. This novel treatment method involves the use of botulinum toxin type A (Botox).

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, plastipore cartilage grafts etc.) We will investigate a new method of treatment for ENS. This will involve injection of botulinum toxin 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 botulinum toxin type A in improving overall quality of life in ENS patients.

Methods:

ENS patients in this study will receive botulinum toxin type A along with adjunctive treatment which will include several measures. First of all, patients will be given a nasal rinse bottle and will be instructed to irrigate their noses twice a day as follows:

• Irrigate the nose 250cc (about 125cc each side) to clear the mucus.

• Stop and gently clear the nose.

• Irrigate the nose 250cc (about 125cc each side) once again.

• Sit quietly for 10 minutes. No blowing.

• Do not blow the nose for 2 hours.

Patients will be asked to use sesame oil once a day to prevent drying of the nasal mucosa with further administration as needed. In addition they will advised to make certain lifestyle modifications that will include sleeping with a cool mist humidifier, drinking plenty of fluids and engaging in regular physical activity.

Before and after treatment data will be obtained in the form of a breathing test and patient questionnaires that will measure changes in physical and mental health.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrophic Rhinitis
• Empty Nose Syndrome
• Syndrome

Intervention

Drug:
• Botulinum Toxin Type A
10 Units of Botulinum Toxin Type A injected into the dilator nasalis muscle on each side of the nose.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Score of Sino Nasal Outcome Test 22 (SNOT 22)	The SNOT 22 is a validated measure of health related quality of life in sinonasal disease. It is a 22 item questionnaire with each item assigned a score ranging from 0-5. The total score may range from 0-110 and lower scores represent better health related quality of life.	2 weeks after intervention, 2 months	No

External Links

•   FDA website. Great website for information on Botox.
•   Information on Botox from the US Food and Drug Administration.
•   Mayo Clinic Clinical Trials
•   online blog of people with empty nose syndrome.
•   Online listing of the study with study details and contact information.