NCT05565430Completed
Vocal Cord Responses During Hyperventilation in Normal Individuals and in Mild and Severe Asthmatics.
Vocal Cord Responses During Hyperventilation in Normal Individuals and in Mild and Severe
Source: ClinicalTrials.gov · Last updated 8 May 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 24 (actual)
- First submitted
- 31 May 2016
- Start date
- Jun 2018
- Primary completion date
- Feb 2025
- Lead sponsor
- Monash Medical Centre
- Diseases
- Asthma
- NCT number
- NCT05565430
What you commit to
- Study type: Observational
- Participants enrolled: 24
- From Jun 2018 to the primary completion date, Feb 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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)
Age
- 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:
- 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.
- Age \< 18 or \> 65
Other
- 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.
- \- Exclusion criteria will include:
- Smoking history \> 10 pack years,
- FEV1 \< 50% predicted
- Singers
- Pregnancy
Who the study is looking for
- Inclusion criteria for healthy controls include:
- age \>18 to 65 years old
- non-smokers
- No history of chronic respiratory symptoms.
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Monash Medical Centre Coordinator of this site? Confirm its status | Clayton | Australia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.