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

This study has been terminated.
(Lead investigator moved to a new medical center; study was stopped when he left.)
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00732680
First received: August 8, 2008
Last updated: December 30, 2013
Last verified: December 2013
  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.

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).


Condition Intervention Phase
Empty Nose Syndrome
Atrophic Rhinitis
Drug: Botulinum Toxin Type A
Phase 1
Phase 2

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


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Mean Score of Sino Nasal Outcome Test 22 (SNOT 22) [ Time Frame: 2 weeks after intervention, 2 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 9
Study Start Date: December 2008
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: Botulinum Toxin Type A
10 Units of Botulinum Toxin Type A injected into the dilator nasalis muscle on each side of the nose.
Other Name: 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.

  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
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: NCT00732680

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55904
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Oren Friedman, M.D. Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Oren Friedman M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00732680     History of Changes
Other Study ID Numbers: 08-005015
Study First Received: August 8, 2008
Results First Received: November 13, 2013
Last Updated: December 30, 2013
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
Rhinitis, Atrophic
Atrophy
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Pathological Conditions, Anatomical
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 26, 2014