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

NCT ID: NCT00732680

Last Updated: 2016-04-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2009-11-30

Brief 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).

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, 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.

Conditions

Empty Nose Syndrome; Atrophic Rhinitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Botulinum Toxin Type A

Treatment will be in the form of 10 Units of Botulinum Toxin Type A injected into the dilator nasalis muscle on each side of the nose.

Group Type: EXPERIMENTAL

Botulinum Toxin Type A

Intervention Type: DRUG

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

Interventions

Botulinum Toxin Type A

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

Intervention Type: DRUG

Other Intervention Names

Botox

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Oren Friedman, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Related Links

http://www.clinicaltrials.gov

Online listing of the study with study details and contact information.

http://www.fda.gov/

FDA website. Great website for information on Botox.

http://www.emptynosesyndrome.org/

online blog of people with empty nose syndrome.

Other Identifiers

08-005015

Identifier Type: -

Identifier Source: org_study_id