NCT05114083

Brief Summary

Dr. Russell Traister, et al, describes a symptom scoring system based on retrospective chart review to help identify subjects with VCD. Dr. Traister assigned the following symptom scores: dysphonia (2), throat tightness (4), sensitivity to odors (3) and absence of wheezing (2). Patients scoring 4 or more points have a positive predictive value of 96% and a negative predictive value of 77% for VCD. This prospective study will look at a population of patients presenting to a large tertiary care referral center for symptoms of cough. Patients seen at the "Cough Clinic" are evaluated by a Pulmonologist and an Otolaryngologist. Each patient undergoes pulmonary function testing and VLS testing as part of the diagnostic workup. For this study the history would be expanded to include the 4 specific symptoms: dysphonia, throat tightness, sensitivity to odors and absence of wheezing. The symptoms will be scored and compared against the results of diagnostic testing to determine if these symptoms help predict those with vocal cord dysfunction (VCD).

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2017

Longer than P75 for all trials

Status
withdrawn

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

September 24, 2015

Completed
1.3 years until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 9, 2021

Completed
Last Updated

November 9, 2021

Status Verified

October 1, 2021

Enrollment Period

4.8 years

First QC Date

September 24, 2015

Last Update Submit

October 28, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Determine if symptom scoring can accurately predict vocal cord dysfunction

    We will score each patient according to their symptoms of vocal cord dysfunction including; throat tightness (4 points), dysphonia (2 points), absence of wheezing (2 points), symptoms triggered by strong odors (3 points). A positive response will be assigned the score as indicated in parentheses behind each symptom. A negative response will be assigned zero points.

    1 year

Interventions

symptom assessment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All participants male and female, age 18 years and older presenting as new patients to the Cough Clinic will be asked to participate if they are not attended by a guardian or an interpreter. Everyone (regardless if they choose to participate or not) will receive current standard practice/care of the Cough Clinic for evaluation, testing and treatment.

You may qualify if:

  • All participants male and female,
  • age 18 years and older
  • presenting as new patients to the Cough Clinic

You may not qualify if:

  • Participants less than 18 years of age and those attended by a guardian or an interpreter

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Parsons JP, Benninger C, Hawley MP, Philips G, Forrest LA, Mastronarde JG. Vocal cord dysfunction: beyond severe asthma. Respir Med. 2010 Apr;104(4):504-9. doi: 10.1016/j.rmed.2009.11.004. Epub 2009 Dec 4.

    PMID: 19962874BACKGROUND
  • Wilson JJ, Theis SM, Wilson EM. Evaluation and management of vocal cord dysfunction in the athlete. Curr Sports Med Rep. 2009 Mar-Apr;8(2):65-70. doi: 10.1249/JSR.0b013e31819def3d.

    PMID: 19276905BACKGROUND
  • Sterner JB, Morris MJ, Sill JM, Hayes JA. Inspiratory flow-volume curve evaluation for detecting upper airway disease. Respir Care. 2009 Apr;54(4):461-6.

    PMID: 19327180BACKGROUND
  • Benninger C, Parsons JP, Mastronarde JG. Vocal cord dysfunction and asthma. Curr Opin Pulm Med. 2011 Jan;17(1):45-9. doi: 10.1097/MCP.0b013e32834130ee.

    PMID: 21330824BACKGROUND
  • Traister RS, Fajt ML, Landsittel D, Petrov AA. A novel scoring system to distinguish vocal cord dysfunction from asthma. J Allergy Clin Immunol Pract. 2014 Jan-Feb;2(1):65-9. doi: 10.1016/j.jaip.2013.09.002. Epub 2013 Nov 2.

    PMID: 24565771BACKGROUND

MeSH Terms

Conditions

Vocal Cord Dysfunction

Condition Hierarchy (Ancestors)

Laryngeal DiseasesRespiratory Tract DiseasesRespiration DisordersOtorhinolaryngologic Diseases

Study Officials

  • Jonathan Parsons, MD

    Ohio State University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Internal Medicine

Study Record Dates

First Submitted

September 24, 2015

First Posted

November 9, 2021

Study Start

January 1, 2017

Primary Completion

October 1, 2021

Study Completion

October 1, 2021

Last Updated

November 9, 2021

Record last verified: 2021-10