Empty Nose SyndromePhase 1/2NCT00732680
Benefits of the Use of Botox in the Treatment of Empty Nose Syndrome Syndrome
A Phase 1/2 study testing Botulinum Toxin Type A in people with Empty Nose Syndrome and Atrophic Rhinitis, run by Mayo Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Empty Nose Syndrome, Atrophic Rhinitis
- What is being tested?
- Botulinum Toxin Type A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Nov 2009
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any patient aged 18-65 years of age presenting with a known diagnosis of ENS who has no known allergies to Botox.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Empty Nose Syndrome, Atrophic Rhinitis
- Being tested
- Botulinum Toxin Type A
- Keywords
- Empty nose syndrome, Over resection of turbinate, Atrophic rhinitis
- Medical subject headings
- Rhinitis, Atrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Botox
10 Units of Botulinum Toxin Type A injected into the dilator nasalis muscle on each side of the nose.
| Study group | Role | What they receive |
|---|---|---|
| Botulinum Toxin Type A | Experimental | 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. Receives: Drug: Botulinum Toxin Type A |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks after intervention, 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2008 (estimated)
- Study startDec 2008
- Primary completionNov 2009
- Study completionNov 2009
Why it stopped: Lead investigator moved to a new medical center; study was stopped when he left.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Empty Nose SyndromeStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oren Friedman, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00732680
- Sponsor's protocol ID
- 08-005015
- Status last verified
- Mar 2016
- First submitted
- 8 Aug 2008
- Last updated
- 18 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Case Series Evaluating Short and Long Term Benefits of the Use of Botox in the Treatment of Empty Nose Syndrome
- ClinicalTrials.gov ID
- NCT00732680
- Acronym / sponsor ID
- 08-005015
- Conditions
- Empty Nose Syndrome, Atrophic Rhinitis
- Keywords
- Empty nose syndrome, Over resection of turbinate, Atrophic rhinitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lead investigator moved to a new medical center; study was stopped when he left.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 12 Aug 2008 (estimated)
- Results
- Posted 13 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Botulinum Toxin Type A | Experimental | Drug: Botulinum Toxin Type ATreatment 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any patient aged 18-65 years of age presenting with a known diagnosis of ENS who has no known allergies to Botox.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum Toxin Type AAlso: Botox10 Units of Botulinum Toxin Type A injected into the dilator nasalis muscle on each side of the nose. | Drug | Botulinum Toxin Type A |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Online listing of the study with study details and contact information.Link provided by the sponsor.
- FDA website. Great website for information on Botox.Link provided by the sponsor.
- online blog of people with empty nose syndrome.Link provided by the sponsor.
Related trials for Empty Nose Syndrome
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Not yet recruiting
Acoustic Resonance Therapy for Treating Empty Nose Syndrome
Empty Nose Syndrome, Nasal Obstruction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oren Friedman, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Botulinum Toxin Type A in people with Empty Nose Syndrome and Atrophic Rhinitis, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Score of Sino Nasal Outcome Test 22 (SNOT 22) (time frame: 2 weeks after intervention, 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2016.