DyspneaVCDNCT00906867
Pulmonary Function Test, Bronchial Hyperresponsiveness and Quality of Life in Patients With Vocal Cord Dysfunction (VCD)
An observational study of Dyspnea, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 30 years
- Conditions the study is for
- Dyspnea
- What is being tested?
- Methacholine challenge testing and Rhino-laryngoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2009to Mar 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Outpatients of departement of Pediatric Pulmonology and Allergology.
Who may be able to join
- Informed consent
- Age 7 to 30 Years
- Documented VCD or strong suspicion of VCD
- Pulmonary function test: FEV1 (% pred.) ≥ 70%
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Dyspnea
- Being tested
- Methacholine challenge testing, Rhino-laryngoscopy
- Keywords
- Vocal cord dysfunction, Laryngoscopy, Methacholine challenge, Pulmonary function testing
- Medical subject headings
- Dyspnea, Vocal Cord Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methacholine challenge testingOther
Also called Aerosol Provocation System (Cardinal Health GmbH)
Nebulized methacholine administered at the following doses: 0,1 mg/0,4 mg/0,8 mg/1,6 mg
Rhino-laryngoscopyProcedure or surgery
Also called ENF-V2 laryngoscope Olympus
Topical anesthesia (Xylocain Pump spray) followed by transnasal fiberoptic laryngoscopy with a flexible fiberoptic laryngoscope.
| Study group | Role | What they receive |
|---|---|---|
| Vocal cord dysfunction | Patients with suspicion of VCD Receives: Other: Methacholine challenge testing; Procedure: Rhino-laryngoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of vocal cord dysfunction, and evaluation of predictors as atopy, bronchial hyperresponsiveness, and psychiatric behavior.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2009 (estimated)
- Study startApr 2009
- Primary completionFeb 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for DyspneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johannes Schulze MD, Johann Wolfgang Goethe University Hospital
- Investigators
- Stefan Zielen, Prof, Principal investigator, Goethe University, Frankfurt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00906867
- Sponsor's protocol ID
- KGU-62/09
- Acronym
- VCD
- Status last verified
- Mar 2017
- First submitted
- 20 May 2009
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 12475837Guss 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.
PubMed 16954978Husein OF, Husein TN, Gardner R, Chiang T, Larson DG, Obert K, Thompson J, Trudeau MD, Dell DM, Forrest LA. Formal psychological testing in patients with paradoxical vocal fold dysfunction. Laryngoscope. 2008 Apr;118(4):740-7. doi: 10.1097/MLG.0b013e31815ed13a.
PubMed 18182970Sandage MJ, Zelazny SK. Paradoxical vocal fold motion in children and adolescents. Lang Speech Hear Serv Sch. 2004 Oct;35(4):353-62. doi: 10.1044/0161-1461(2004/034).
PubMed 15609638Loughlin CJ, Koufman JA. Paroxysmal laryngospasm secondary to gastroesophageal reflux. Laryngoscope. 1996 Dec;106(12 Pt 1):1502-5. doi: 10.1097/00005537-199612000-00011.
PubMed 8948611Newman KB, Mason UG 3rd, Schmaling KB. Clinical features of vocal cord dysfunction. Am J Respir Crit Care Med. 1995 Oct;152(4 Pt 1):1382-6. doi: 10.1164/ajrccm.152.4.7551399.
PubMed 7551399Mikita CP, Mikita JA. Allergic bronchopulmonary aspergillosis. Allergy Asthma Proc. 2006 Jan-Feb;27(1):82-4.
PubMed 16598999Crapo RO, Casaburi R, Coates AL, Enright PL, Hankinson JL, Irvin CG, MacIntyre NR, McKay RT, Wanger JS, Anderson SD, Cockcroft DW, Fish JE, Sterk PJ. Guidelines for methacholine and exercise challenge testing-1999. This official statement of the American Thoracic Society was adopted by the ATS Board of Directors, July 1999. Am J Respir Crit Care Med. 2000 Jan;161(1):309-29. doi: 10.1164/ajrccm.161.1.ats11-99. No abstract available.
PubMed 10619836Asher MI, Keil U, Anderson HR, Beasley R, Crane J, Martinez F, Mitchell EA, Pearce N, Sibbald B, Stewart AW, et al. International Study of Asthma and Allergies in Childhood (ISAAC): rationale and methods. Eur Respir J. 1995 Mar;8(3):483-91. doi: 10.1183/09031936.95.08030483.
PubMed 7789502
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Function Test, Bronchial Hyperresponsiveness and Quality of Life in Patients With Vocal Cord Dysfunction (VCD)
- ClinicalTrials.gov ID
- NCT00906867
- Acronym / sponsor ID
- VCD / KGU-62/09
- Conditions
- Dyspnea
- Keywords
- Vocal cord dysfunction, Laryngoscopy, Methacholine challenge, Pulmonary function testing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 21 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vocal cord dysfunction | – | Other: Methacholine challenge testing, Procedure: Rhino-laryngoscopyPatients with suspicion of VCD |
Who may qualify
- Ages
- 7 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Outpatients of departement of Pediatric Pulmonology and Allergology.
Key inclusion criteria (4 listed)
- Informed consent
- Age 7 to 30 Years
- Documented VCD or strong suspicion of VCD
- Pulmonary function test: FEV1 (% pred.) ≥ 70%
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methacholine challenge testingAlso: Aerosol Provocation System (Cardinal Health GmbH)Nebulized methacholine administered at the following doses: 0,1 mg/0,4 mg/0,8 mg/1,6 mg | Other | Vocal cord dysfunction |
| Rhino-laryngoscopyAlso: ENF-V2 laryngoscope OlympusTopical anesthesia (Xylocain Pump spray) followed by transnasal fiberoptic laryngoscopy with a flexible fiberoptic laryngoscope. | Procedure or surgery | Vocal cord dysfunction |
Primary outcome
Characterization of vocal cord dysfunction, and evaluation of predictors as atopy, bronchial hyperresponsiveness, and psychiatric behavior.
Time frame: one day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- Background: PubMed 12475837Perkins 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.
- Background: PubMed 16954978Guss 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.
- Background: PubMed 18182970Husein OF, Husein TN, Gardner R, Chiang T, Larson DG, Obert K, Thompson J, Trudeau MD, Dell DM, Forrest LA. Formal psychological testing in patients with paradoxical vocal fold dysfunction. Laryngoscope. 2008 Apr;118(4):740-7. doi: 10.1097/MLG.0b013e31815ed13a.
- Background: PubMed 15609638Sandage MJ, Zelazny SK. Paradoxical vocal fold motion in children and adolescents. Lang Speech Hear Serv Sch. 2004 Oct;35(4):353-62. doi: 10.1044/0161-1461(2004/034).
- Background: PubMed 8948611Loughlin CJ, Koufman JA. Paroxysmal laryngospasm secondary to gastroesophageal reflux. Laryngoscope. 1996 Dec;106(12 Pt 1):1502-5. doi: 10.1097/00005537-199612000-00011.
- Background: PubMed 7551399Newman KB, Mason UG 3rd, Schmaling KB. Clinical features of vocal cord dysfunction. Am J Respir Crit Care Med. 1995 Oct;152(4 Pt 1):1382-6. doi: 10.1164/ajrccm.152.4.7551399.
- Background: PubMed 16598999Mikita CP, Mikita JA. Allergic bronchopulmonary aspergillosis. Allergy Asthma Proc. 2006 Jan-Feb;27(1):82-4.
- Background: PubMed 10619836Crapo RO, Casaburi R, Coates AL, Enright PL, Hankinson JL, Irvin CG, MacIntyre NR, McKay RT, Wanger JS, Anderson SD, Cockcroft DW, Fish JE, Sterk PJ. Guidelines for methacholine and exercise challenge testing-1999. This official statement of the American Thoracic Society was adopted by the ATS Board of Directors, July 1999. Am J Respir Crit Care Med. 2000 Jan;161(1):309-29. doi: 10.1164/ajrccm.161.1.ats11-99. No abstract available.
- Background: PubMed 7789502Asher MI, Keil U, Anderson HR, Beasley R, Crane J, Martinez F, Mitchell EA, Pearce N, Sibbald B, Stewart AW, et al. International Study of Asthma and Allergies in Childhood (ISAAC): rationale and methods. Eur Respir J. 1995 Mar;8(3):483-91. doi: 10.1183/09031936.95.08030483.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Zielen, Prof principal investigator
Goethe University, Frankfurt, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dyspnea, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of vocal cord dysfunction, and evaluation of predictors as atopy, bronchial hyperresponsiveness, and psychiatric behavior. (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00906867, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2017.