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

NCT00906867 | Completed

• 1 other identifier: KGU-62/09
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dyspnea

Keywords

Vocal cord dysfunction; Laryngoscopy; Methacholine challenge; Pulmonary function testing

Outcome Measures

Primary Outcomes (1)

• Characterization of vocal cord dysfunction, and evaluation of predictors as atopy, bronchial hyperresponsiveness, and psychiatric behavior.

  one day

Study Arms (1)

Vocal cord dysfunction

Patients with suspicion of VCD

Other: Methacholine challenge testing; Procedure: Rhino-laryngoscopy

Interventions

Methacholine challenge testing OTHER

Nebulized methacholine administered at the following doses: 0,1 mg/0,4 mg/0,8 mg/1,6 mg

Also known as: Aerosol Provocation System (Cardinal Health GmbH)

Vocal cord dysfunction

Rhino-laryngoscopy PROCEDURE

Topical anesthesia (Xylocain Pump spray) followed by transnasal fiberoptic laryngoscopy with a flexible fiberoptic laryngoscope.

Also known as: ENF-V2 laryngoscope Olympus

Vocal cord dysfunction

Eligibility Criteria

• Age: 7 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Outpatients of departement of Pediatric Pulmonology and Allergology.

You may qualify if:

• Informed consent
• Age 7 to 30 Years
• Documented VCD or strong suspicion of VCD
• Pulmonary function test: FEV1 (% pred.) ≥ 70%

You may not qualify if:

• 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

Sponsors & Collaborators

• Johann Wolfgang Goethe University Hospital: lead

Study Sites (1)

Goethe University Hospital

Frankfurt am Main, Hesse, 60596, Germany

Location

Related Publications (9)

• Perkins PJ, Morris MJ. Vocal cord dysfunction induced by methacholine challenge testing. Chest. 2002 Dec;122(6):1988-93. doi: 10.1378/chest.122.6.1988.

  PMID: 12475837 BACKGROUND

• Guss J, Mirza N. Methacholine challenge testing in the diagnosis of paradoxical vocal fold motion. Laryngoscope. 2006 Sep;116(9):1558-61. doi: 10.1097/01.mlg.0000228007.74561.33.

  PMID: 16954978 BACKGROUND

• 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.

  PMID: 18182970 BACKGROUND

• Sandage MJ, Zelazny SK. Paradoxical vocal fold motion in children and adolescents. Lang Speech Hear Serv Sch. 2004 Oct;35(4):353-62. doi: 10.1044/0161-1461(2004/034).

  PMID: 15609638 BACKGROUND

• Loughlin CJ, Koufman JA. Paroxysmal laryngospasm secondary to gastroesophageal reflux. Laryngoscope. 1996 Dec;106(12 Pt 1):1502-5. doi: 10.1097/00005537-199612000-00011.

  PMID: 8948611 BACKGROUND

• 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. doi: 10.1164/ajrccm.152.4.7551399.

  PMID: 7551399 BACKGROUND

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

  PMID: 16598999 BACKGROUND

• 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. doi: 10.1164/ajrccm.161.1.ats11-99. No abstract available.

  PMID: 10619836 BACKGROUND

• 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. doi: 10.1183/09031936.95.08030483.

  PMID: 7789502 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, total IgE

MeSH Terms

Conditions

Dyspnea; Vocal Cord Dysfunction

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Laryngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Stefan Zielen, Prof

  Goethe University, Frankfurt, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cosultant Pediatric Allergy and Pulmonolgy

Study Record Dates

• First Submitted: May 20, 2009
• First Posted: May 21, 2009
• Study Start: April 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: March 1, 2010
• Last Updated: March 3, 2017

Record last verified: 2017-03

Locations

DE (1)