Register a trial

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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.
Scientific title
Vocal Cord Responses During Hyperventilation in Normal Individuals and in Mild and Severe
Secondary ID [1] 0 0
16151A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hyperventilation 0 0
Larynx 0 0
Asthma 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Vocal cord aperture measured using continuous laryngoscopy after hyperventilation in normal subjects and asthmatics
Timepoint [1] 0 0
6 years
Secondary outcome [1] 0 0
Lung function indices after hyperventilation in normal and asthmatic patients.
Timepoint [1] 0 0
6 years
Secondary outcome [2] 0 0
Role of the extra-thoracic airway hyper-responsiveness measured using bronchial provocation test to identify asthma like symptoms.
Timepoint [2] 0 0
6 years
Secondary outcome [3] 0 0
Vocal cord changes after anti-cholinergic inhalers and/or exercise.
Timepoint [3] 0 0
6 years

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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2024
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash Medical Centre - Clayton
Recruitment postcode(s) [1] 0 0
3169 - Clayton

Funding & Sponsors
Primary sponsor type
Other
Name
Monash Medical Centre
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Laurence Ruane, BSc
Address 0 0
Monash Health and Monash University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Laurence Ruane, BSc
Address 0 0
Country 0 0
Phone 0 0
+61 (03) 9594 2811
Fax 0 0
Email 0 0
laurence.ruane@monashhealth.org
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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)
When will data be available (start and end dates)?
10 years
Available to whom?
All
Available for what types of analyses?
How or where can data be obtained?


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