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

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ClinicalTrials.gov Identifier: NCT00732680
Recruitment Status : Terminated (Lead investigator moved to a new medical center; study was stopped when he left.)
First Posted : August 12, 2008
Results First Posted : February 13, 2014
Last Update Posted : April 18, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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).


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

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : December 2008
Primary Completion Date : November 2009
Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Mean Score of Sino Nasal Outcome Test 22 (SNOT 22) [ Time Frame: 2 weeks after intervention, 2 months ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00732680     History of Changes
Other Study ID Numbers: 08-005015
First Posted: August 12, 2008    Key Record Dates
Results First Posted: February 13, 2014
Last Update Posted: April 18, 2016
Last Verified: March 2016

Keywords provided by Mayo Clinic:
Empty nose syndrome
Over resection of turbinate
Atrophic rhinitis

Additional relevant MeSH terms:
Syndrome
Rhinitis
Atrophy
Rhinitis, Atrophic
Disease
Pathologic Processes
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Pathological Conditions, Anatomical
Botulinum Toxins
onabotulinumtoxinA
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents