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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johannes Schulze MD, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT00906867
First received: May 20, 2009
Last updated: October 7, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention
- Dyspnea
Other: Methacholine challenge testing
Procedure: Rhino-laryngoscopy

Study Type: Observational
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)

Resource links provided by NLM:


Further study details as provided by Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:
  • Characterization of vocal cord dysfunction, and evaluation of predictors as atopy, bronchial hyperresponsiveness, and psychiatric behavior. [ Time Frame: one day ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples Without DNA

Serum, total IgE


Enrollment: 25
Study Start Date: April 2009
Study Completion Date: March 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   7 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Outpatients of departement of Pediatric Pulmonology and Allergology.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00906867

Locations
Germany
Goethe University Hospital
Frankfurt, Hesse, Germany, 60596
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospitals
Investigators
Principal Investigator: Stefan Zielen, Prof Goethe University, Frankfurt, Germany
  More Information

Publications:

Responsible Party: Johannes Schulze MD, Cosultant Pediatric Allergy and Pulmonolgy, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier: NCT00906867     History of Changes
Other Study ID Numbers: KGU-62/09
Study First Received: May 20, 2009
Last Updated: October 7, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by Johann Wolfgang Goethe University Hospitals:
Vocal cord dysfunction
Laryngoscopy
Methacholine challenge
Pulmonary function testing

Additional relevant MeSH terms:
Bronchial Hyperreactivity
Vocal Cord Dysfunction
Bronchial Diseases
Laryngeal Diseases
Otorhinolaryngologic Diseases
Respiration Disorders
Respiratory Tract Diseases
Methacholine Chloride
Autonomic Agents
Bronchoconstrictor Agents
Cholinergic Agents
Cholinergic Agonists
Miotics
Molecular Mechanisms of Pharmacological Action
Muscarinic Agonists
Neurotransmitter Agents
Parasympathomimetics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014