Pulmonary Function Test, Bronchial Hyperresponsiveness and Quality of Life in Patients With Vocal Cord Dysfunction (VCD) (VCD)
|Study Design:||Observational Model: Case-Only
Time Perspective: Cross-Sectional
|Official Title:||Pulmonary Function Test, Bronchial Hyperresponsiveness and Quality of Life in Patients With Vocal Cord Dysfunction (VCD)|
- Characterization of vocal cord dysfunction, and evaluation of predictors as atopy, bronchial hyperresponsiveness, and psychiatric behavior. [ Time Frame: one day ]
Biospecimen Retention: Samples Without DNA
|Study Start Date:||April 2009|
|Study Completion Date:||March 2010|
|Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
Vocal cord dysfunction
Patients with suspicion of VCD
Other: Methacholine challenge testing
Nebulized methacholine administered at the following doses: 0,1 mg/0,4 mg/0,8 mg/1,6 mg
Other Name: Aerosol Provocation System (Cardinal Health GmbH)Procedure: Rhino-laryngoscopy
Topical anesthesia (Xylocain Pump spray) followed by transnasal fiberoptic laryngoscopy with a flexible fiberoptic laryngoscope.
Other Name: ENF-V2 laryngoscope Olympus
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00906867
|Goethe University Hospital|
|Frankfurt, Hesse, Germany, 60596|
|Principal Investigator:||Stefan Zielen, Prof||Goethe University, Frankfurt, Germany|