NCT00732680

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2008

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 12, 2008

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
4.3 years until next milestone

Results Posted

Study results publicly available

February 13, 2014

Completed
Last Updated

April 18, 2016

Status Verified

March 1, 2016

Enrollment Period

11 months

First QC Date

August 8, 2008

Results QC Date

November 13, 2013

Last Update Submit

March 18, 2016

Conditions

Empty Nose SyndromeAtrophic Rhinitis

Keywords

Empty nose syndromeOver resection of turbinateAtrophic rhinitis

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 weeks after intervention, 2 months

Study Arms (1)

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.

Drug: Botulinum Toxin Type A

Interventions

Botulinum Toxin Type ADRUG

10 Units of Botulinum Toxin Type A injected into the dilator nasalis muscle on each side of the nose.

Also known as: Botox
Botulinum Toxin Type A

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any patient aged 18-65 years of age presenting with a known diagnosis of ENS who has no known allergies to Botox.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55904, United States

Location

Related Links

MeSH Terms

Conditions

Rhinitis, Atrophic

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Limitations and Caveats

No study data was collected in the study. The Lead investigator moved to a new medical center; the study was stopped when he left.

Results Point of Contact

Title
Rizwan Siwani, MBBS
Organization
Mayo Clinic
siwani.rizwan@mayo.edu
507-284-9155

Study Officials

  • Oren Friedman, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2008

First Posted

August 12, 2008

Study Start

December 1, 2008

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

April 18, 2016

Results First Posted

February 13, 2014

Record last verified: 2016-03

Locations

US(1)