Clinical Trials Directory

Trials / Completed

CompletedNCT00906867

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

Status
Completed
Phase
Study type
Observational
Enrollment
25 (actual)
Sponsor
Johann Wolfgang Goethe University Hospital · Academic / Other
Sex
All
Age
7 Years – 30 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERMethacholine challenge testingNebulized methacholine administered at the following doses: 0,1 mg/0,4 mg/0,8 mg/1,6 mg
PROCEDURERhino-laryngoscopyTopical anesthesia (Xylocain Pump spray) followed by transnasal fiberoptic laryngoscopy with a flexible fiberoptic laryngoscope.

Timeline

Start date
2009-04-01
Primary completion
2010-02-01
Completion
2010-03-01
First posted
2009-05-21
Last updated
2017-03-03

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT00906867. Inclusion in this directory is not an endorsement.