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

August 8, 2008
December 30, 2013
December 2008
November 2009   (final data collection date for primary outcome measure)
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.
The endpoints will include the patient questionnaire scores 2 months post-intervention (Snot 22 score, BDI-2 score) and rhinomanometry measurements. [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00732680 on ClinicalTrials.gov Archive Site
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Benefits of the Use of Botox in the Treatment of Empty Nose Syndrome Syndrome
Prospective Case Series Evaluating Short and Long Term Benefits of the Use of Botox in the Treatment of Empty Nose Syndrome

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).

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.

Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Empty Nose Syndrome
  • Atrophic Rhinitis
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
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.
Intervention: Drug: Botulinum Toxin Type A
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
9
November 2009
November 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00732680
08-005015
No
Oren Friedman M.D., Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Oren Friedman, M.D. Mayo Clinic
Mayo Clinic
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP