Vocal Cord Responses During Hyperventilation in Normal Individuals and in Mild and Severe Asthmat… (NCT05565430) | Clinical Trial Compass
CompletedNot Applicable
Vocal Cord Responses During Hyperventilation in Normal Individuals and in Mild and Severe Asthmatics.
Australia24 participantsStarted 2018-06-01
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
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).
*…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Vocal cord aperture measured using continuous laryngoscopy after hyperventilation in normal subjects and asthmatics