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

Completed

• Conditions: Dyspnea
• Interventions: Other: Methacholine challenge testing; Procedure: Rhino-laryngoscopy

• Registration Number: NCT00906867
• Lead Sponsor: Johann Wolfgang Goethe University Hospital

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.

Detailed 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.

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-05-20
• Study First Submitted QC: 2009-05-20
• Study First Posted: 2009-05-21
• Primary Completion: 2010-02
• Study Completion: 2010-03
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-02
• Last Update Posted: 2017-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Vocal cord dysfunction	Methacholine challenge testing	Patients with suspicion of VCD
Vocal cord dysfunction	Rhino-laryngoscopy	Patients with suspicion of VCD

Primary Outcome Measures

Name	Time	Method
Characterization of vocal cord dysfunction, and evaluation of predictors as atopy, bronchial hyperresponsiveness, and psychiatric behavior.	one day

Trial Locations

Locations (1)

Goethe University Hospital; 🇩🇪 Frankfurt, Hesse, Germany