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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05565430




Registration number
NCT05565430
Ethics application status
Date submitted
31/05/2016
Date registered
4/10/2022
Date last updated
23/10/2023

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 - Acute Hyperventilation and effects on vocal cord movement.
Chronic Hyperventilation and effects on vocal cord movement.
Effects of anticholinergic medication on paradoxical vocal cord movement.

Mild Asthmatics - Acute Hyperventilation and effects on vocal cord movement.
Chronic Hyperventilation and effects on vocal cord movement.
Effects of anticholinergic medication on paradoxical vocal cord movement.

Severe Asthmatics - Acute Hyperventilation and effects on vocal cord movement.
Chronic Hyperventilation and effects on vocal cord movement.
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
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05565430
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05565430