Atrophic Rhinitis, Empty Nose Syndrome
Conditions
Keywords
Empty nose syndrome, Over resection of turbinate, Atrophic rhinitis
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.
Interventions
DRUGBotulinum Toxin Type A
10 Units of Botulinum Toxin Type A injected into the dilator nasalis muscle on each side of the nose.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Score of Sino Nasal Outcome Test 22 (SNOT 22) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 9 |
| Total | 9 |
Baseline characteristics
| Characteristic | Botulinum Toxin Type A |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Region of Enrollment United States | 9 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 9 |
| serious Total, serious adverse events | 0 / 9 |
Outcome results
Primary
Mean Score of Sino Nasal Outcome Test 22 (SNOT 22)
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.
Time frame: 2 weeks after intervention, 2 months
Population: No study data was collected in the study. The Lead investigator moved to a new medical center; the study was stopped when he left.