Clinical trial NCT00732680: Benefits of the Use of Botox in the Treatment of Empty Nose Syndrome Syndrome
Official title: Prospective Case Series Evaluating Short and Long Term Benefits of the Use of Botox in the Treatment of Empty Nose Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Empty Nose Syndrome
Atrophic Rhinitis
Keywords: Empty nose syndrome
Over resection of turbinate
Atrophic rhinitis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2008-08-12
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Mean Score of Sino Nasal Outcome Test 22 (SNOT 22)
timeFrame: 2 weeks after intervention, 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Oren Friedman, M.D.
role: PRINCIPAL_INVESTIGATOR
References: