Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05565430
Registration number
NCT05565430
Ethics application status
Date submitted
31/05/2016
Date registered
4/10/2022
Titles & IDs
Public title
Vocal Cord Responses During Hyperventilation in Normal Individuals and in Mild and Severe Asthmatics.
Query!
Scientific title
Vocal Cord Responses During Hyperventilation in Normal Individuals and in Mild and Severe
Query!
Secondary ID [1]
0
0
16151A
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Hyperventilation
0
0
Query!
Larynx
0
0
Query!
Asthma
0
0
Query!
Condition category
Condition code
Respiratory
0
0
0
0
Query!
Other respiratory disorders / diseases
Query!
Intervention/exposure
Study type
Observational
Query!
Patient registry
Query!
Target follow-up duration
Query!
Target follow-up type
Query!
Description of intervention(s) / exposure
Other interventions - Acute Hyperventilation
Other interventions - Chronic hyperventilation
Treatment: Drugs - Effects of anticholinergic medication
Healthy Control - 1. Acute Hyperventilation and effects on vocal cord movement.
2. Chronic Hyperventilation and effects on vocal cord movement.
3. Effects of anticholinergic medication on paradoxical vocal cord movement.
Mild Asthmatics - 1. Acute Hyperventilation and effects on vocal cord movement.
2. Chronic Hyperventilation and effects on vocal cord movement.
3. Effects of anticholinergic medication on paradoxical vocal cord movement.
Severe Asthmatics - 1. Acute Hyperventilation and effects on vocal cord movement.
2. Chronic Hyperventilation and effects on vocal cord movement.
3. Effects of anticholinergic medication on paradoxical vocal cord movement.
Other interventions: Acute Hyperventilation
Laryngoscopy to assess vocal cord function during acute hyperventilation in normal subjects and asthmatics.
Other interventions: Chronic hyperventilation
Laryngoscopy to assess vocal cord function during acute hyperventilation in normal subjects and asthmatics.
Treatment: Drugs: Effects of anticholinergic medication
Laryngoscopy to assess vocal cord function after administration of anticholinergic medication.
Query!
Intervention code [1]
0
0
Other interventions
Query!
Intervention code [2]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Vocal cord aperture measured using continuous laryngoscopy after hyperventilation in normal subjects and asthmatics
Query!
Assessment method [1]
0
0
For each experiment, the subject will sit in a comfortable armchair and breathe though a rubber mouthpiece and turbine pneumotachometer (Oxycon Delta, Jaeger, Wurzburg, Germany). The airflow and volume signals and that from the carbon dioxide (CO2) analyser will be displayed on a monitor and recorded. Subjects will breath through the spirometer during endoscopy to record respiratory phase for later correlation with laryngeal recording.
Laryngeal movement analysis - Image stills will be taken from the continuous laryngoscopy recording, at end inspiration and end expiration. Measurement of narrowing of the laryngeal structures in relative terms during one breathing cycle, which is independent of the distance between the laryngoscope and the glottis.
Query!
Timepoint [1]
0
0
6 years
Query!
Secondary outcome [1]
0
0
Lung function indices after hyperventilation in normal and asthmatic patients.
Query!
Assessment method [1]
0
0
Spirometry indices after hyperventilation. Baseline spirometry will be recorded. Forced vital capacity (FVC) and forced expiratory volume (FEV1) will be calculated. Both are measurements of volume of air expired after maximum inspiration, measured in litres.
Query!
Timepoint [1]
0
0
6 years
Query!
Secondary outcome [2]
0
0
Role of the extra-thoracic airway hyper-responsiveness measured using bronchial provocation test to identify asthma like symptoms.
Query!
Assessment method [2]
0
0
Role of the extra-thoracic airway hyper-responsiveness to asthma like symptoms using Mannitol bronchial provocation testing
Query!
Timepoint [2]
0
0
6 years
Query!
Secondary outcome [3]
0
0
Vocal cord changes after anti-cholinergic inhalers and/or exercise.
Query!
Assessment method [3]
0
0
Vocal cord changes after anti-cholinergic inhalers and/or exercise. Subjects will inhale 4 puffs of ipratropium bromide (20 mcg/actuation inhalation) or placebo using normal tidal breathing. Subjects will then be exercised on an ergometer (Cateye Ergociser) at 75% to 85% of their predicted maximal heart rate (maximal heart rate equals 220 minus subjects age) for 8 minutes while breathing dry air at 10oC. Laryngoscopy will be conducted in situ as detailed in Project 1.
Exercise will be discontinued and PVCM will be assessed. Final lung function testing will be performed to assess the degree of respiratory obstruction produced.
Query!
Timepoint [3]
0
0
6 years
Query!
Eligibility
Key inclusion criteria
Inclusion Criteria for Healthy Controls:
* Inclusion criteria for healthy controls include:
* age >18 to 65 years old
* non-smokers
* No history of chronic respiratory symptoms.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
65
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
Key exclusion criteria
Exclusion Criteria for Healthy Controls:
* Exclusion criteria for controls include:
* Age < 18 or > 65, smokers or smoking history >10 pack years
* Any history of respiratory disorders such as asthma or chronic obstructive pulmonary disease (COPD)
* Known vocal cord pathology (i.e. laryngeal cancer) or diagnosed voice condition
* Known brain or brainstem cancer
* Known head and neck cancer
* Known neurological disorders (i.e. stroke)
* Use of medications (i.e. beta-blockers or anti-cholinergic agents which may interfere with vocal cord function)
* Singers
* Pregnancy.
Inclusion Criterial for Asthmatics:
* The Investigators shall recruit a total of 16 patients with asthma - 8 patients with mild asthma (Group 2) and 8 patients with severe asthma (Group 3).
* Mild asthma will be defined as patients with forced expiratory volume in 1 second (FEV1) >80% predicted.
* Severe asthma will be defined as patients with FEV1 50-60% predicted.
* Asthmatics will also have a forced expiratory ratio (FER) less than the lower limit of normal, indicating obstruction.
* Inclusion criteria will include:
* age 18-65 years
* A history of asthma defined as a bronchodilator response with increase in FEV1 >12% and 200mls or positive bronchoprovocation testing (methacholine).
* Asthmatics will have FEV1 >50% predicted.
Exclusion Criteria for Asthmatics:
- Exclusion criteria will include:
* Age < 18 or > 65
* Smoking history > 10 pack years,
* FEV1 < 50% predicted
* Allergy to anti-cholinergics, known COPD
* Known vocal cord pathology (i.e. laryngeal cancer) or diagnosed voice condition
* Known brain or brainstem cancer
* Known head and neck cancer
* Known neurological disorders (i.e. stroke)
* Singers
* Pregnancy
Query!
Study design
Purpose
Query!
Duration
Query!
Selection
Query!
Timing
Prospective
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/06/2018
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
1/12/2024
Query!
Actual
Query!
Sample size
Target
24
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
VIC
Query!
Recruitment hospital [1]
0
0
Monash Medical Centre - Clayton
Query!
Recruitment postcode(s) [1]
0
0
3169 - Clayton
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
Monash Medical Centre
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The Investigators aim to: 1. Study the effect of hyperventilation on the development of paradoxical vocal cord movement (PVCM) in healthy individuals and in patients with mild and severe asthma, 2. Relate PVCM to airway symptoms and measurements of intra- and extra-thoracic airway hyperresponsiveness (ET-AHR), 3. Evaluate the effects of inhaled anti-cholinergic agents on PVCM induced by hyperventilation. Hypotheses: 1. In health PVCM will not occur in response to hyperventilation, 2. In asthma PVCM will occur in response to hyperventilation, 3. Airway symptoms and ET-AHR will develop in parallel with PVCM, 4. Inhaled anticholinergic agents will prevent PVCM induced by hyperventilation.
Query!
Trial website
https://clinicaltrials.gov/study/NCT05565430
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Laurence Ruane, BSc
Query!
Address
0
0
Monash Health and Monash University
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Laurence Ruane, BSc
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
+61 (03) 9594 2811
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
Though publication
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
Query!
When will data be available (start and end dates)?
10 years
Query!
Available to whom?
All
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05565430