Pulmonary Function Test, Bronchial Hyperresponsiveness an... | NCT00906867

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

NCT00906867

Sponsor

Johann Wolfgang Goethe University Hospital

Status

Completed

Last Update Posted

Mar 3, 2017Actual

Enrollment

25Actual

Phase

Not provided

Conditions

Dyspnea

Interventions

Methacholine challenge testing
Rhino-laryngoscopy

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Feb 2010Actual

Completion Date

Mar 2010Actual

First Submitted Date

May 20, 2009

First Submission Date that Met QC Criteria

May 20, 2009

First Posted Date

May 21, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 2, 2017

Last Update Posted Date

Mar 3, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Johannes Schulze MD, Cosultant Pediatric Allergy and Pulmonolgy, Johann Wolfgang Goethe University HospitalPrincipal Investigator

Lead Sponsor

Johann Wolfgang Goethe University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vocal cord dysfunction		Patients with suspicion of VCD	Other: Methacholine challenge testing Procedure: Rhino-laryngoscopy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Methacholine challenge testing	Other	Nebulized methacholine administered at the following doses: 0,1 mg/0,4 mg/0,8 mg/1,6 mg	Vocal cord dysfunction

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Characterization of vocal cord dysfunction, and evaluation of predictors as atopy, bronchial hyperresponsiveness, and psychiatric behavior.		one day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Years

Maximum Age

30 Years

Standard Ages

ChildAdult

Study Population

Outpatients of departement of Pediatric Pulmonology and Allergology.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stefan Zielen, Prof	Goethe University, Frankfurt, Germany	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Goethe University Hospital		Frankfurt am Main	Hesse	60596	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
12475837	Background	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.
16954978	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.

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms

ID	Term
D004417	Dyspnea
D064706	Vocal Cord Dysfunction