Pulmonary Function Test, Bronchial Hyperresponsiveness and Quality of Life in Patients With Vocal Cord Dysfunction (VCD)

Dyspnea Clinical Trial

— VCD  

Official title:

Pulmonary Function Test, Bronchial Hyperresponsiveness and Quality of Life in Patients With Vocal Cord Dysfunction (VCD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00906867
• Other study ID #: KGU-62/09
• Status: Completed
• Phase: N/A
• First received: May 20, 2009
• Last updated: March 2, 2017
• Start date: April 2009
• Est. completion date: March 2010

Study information

• Verified date: March 2017
• Source: Johann Wolfgang Goethe University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Vocal cord dysfunction is a rare clinical picture. It is labeled as a sudden and threatening dyspnea. Patients with VCD may also present cough, hoarseness, wheezing, and chest tightness, but an inspiratory stridor is the most common symptom. For this reason, such patients are often misdiagnosed with refractory asthma, because of poor response to steroids and bronchodilators. Diagnosis is suspected on clinical grounds and is confirmed with laryngoscopy. The therapy consists of education, speech therapy and if necessary psychotherapy. The purpose of the investigators' study is to characterize children, adolescents, and young adults with VCD, and the evaluation of predictors as atopy, bronchial hyperresponsiveness, and psychiatric features.

Description:

VCD appears to be significantly more common among females. The episode of dyspnea underlies the paradoxical, intermittent adduction of the vocal cords during inspiration. Methacholine challenge testing combined with laryngoscopy is useful in differentiating vocal cord dysfunction from asthma during the asymptomatic period.

In one visit patients will be characterized with a questionnaire based on the ISAAC questionnaire. Furthermore, FeNO, eCO, skin prick testing and total serum IgE will be examined. The psychiatric condition of patients will be determined by CBCL/6-18 and YSR/11-18 behavior questionnaires. After initial fiberoptic laryngoscopy and pulmonary function testing, bronchoprovocation is performed using nebulized methacholine at increasing doses, until a 20% decline in the forced expiratory volume in 1 second is achieved (PD20FEV1). Each methacholine testing will be followed by a second laryngoscopy and pulmonary function testing. The visualization of paradoxical vocal cord motion during inspiration will be recorded.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 30 Years

Eligibility

Inclusion Criteria:

• Informed consent

• Age 7 to 30 Years

• Documented VCD or strong suspicion of VCD

• Pulmonary function test: FEV1 (% pred.) = 70%

Exclusion Criteria:

• Age < 7 and > 30 Years

• Pulmonary function test: FEV1 (% pred.) < 70%

• Others chronic diseases or infections (e.g., HIV, tuberculosis, malignancy)

• Pregnancy

• Documented alcohol, substance, and/or drug abuse

• Incapability to perform all study procedure

• Current participation in another clinical trial

Related Conditions & MeSH terms

• Bronchial Hyperreactivity
• Dyspnea
• Vocal Cord Dysfunction

Intervention

Other:
• Methacholine challenge testing
Nebulized methacholine administered at the following doses: 0,1 mg/0,4 mg/0,8 mg/1,6 mg

Procedure:
• Rhino-laryngoscopy
Topical anesthesia (Xylocain Pump spray) followed by transnasal fiberoptic laryngoscopy with a flexible fiberoptic laryngoscope.

Locations

Country	Name	City	State
Germany	Goethe University Hospital	Frankfurt	Hesse

Sponsors (1)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospital

Country where clinical trial is conducted

Germany, 

References & Publications (9)

Asher MI, Keil U, Anderson HR, Beasley R, Crane J, Martinez F, Mitchell EA, Pearce N, Sibbald B, Stewart AW, et al. International Study of Asthma and Allergies in Childhood (ISAAC): rationale and methods. Eur Respir J. 1995 Mar;8(3):483-91. — View Citation

Crapo RO, Casaburi R, Coates AL, Enright PL, Hankinson JL, Irvin CG, MacIntyre NR, McKay RT, Wanger JS, Anderson SD, Cockcroft DW, Fish JE, Sterk PJ. Guidelines for methacholine and exercise challenge testing-1999. This official statement of the American Thoracic Society was adopted by the ATS Board of Directors, July 1999. Am J Respir Crit Care Med. 2000 Jan;161(1):309-29. — View Citation

Guss J, Mirza N. Methacholine challenge testing in the diagnosis of paradoxical vocal fold motion. Laryngoscope. 2006 Sep;116(9):1558-61. — View Citation

Husein OF, Husein TN, Gardner R, Chiang T, Larson DG, Obert K, Thompson J, Trudeau MD, Dell DM, Forrest LA. Formal psychological testing in patients with paradoxical vocal fold dysfunction. Laryngoscope. 2008 Apr;118(4):740-7. doi: 10.1097/MLG.0b013e31815ed13a. — View Citation

Loughlin CJ, Koufman JA. Paroxysmal laryngospasm secondary to gastroesophageal reflux. Laryngoscope. 1996 Dec;106(12 Pt 1):1502-5. — View Citation

Mikita CP, Mikita JA. Allergic bronchopulmonary aspergillosis. Allergy Asthma Proc. 2006 Jan-Feb;27(1):82-4. — View Citation

Newman KB, Mason UG 3rd, Schmaling KB. Clinical features of vocal cord dysfunction. Am J Respir Crit Care Med. 1995 Oct;152(4 Pt 1):1382-6. — View Citation

Perkins PJ, Morris MJ. Vocal cord dysfunction induced by methacholine challenge testing. Chest. 2002 Dec;122(6):1988-93. — View Citation

Sandage MJ, Zelazny SK. Paradoxical vocal fold motion in children and adolescents. Lang Speech Hear Serv Sch. 2004 Oct;35(4):353-62. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characterization of vocal cord dysfunction, and evaluation of predictors as atopy, bronchial hyperresponsiveness, and psychiatric behavior.		one day