Asthma Clinical Trial
Official title:
Vocal Cord Responses During Hyperventilation in Normal Individuals and in Mild and Severe
NCT number | NCT05565430 |
Other study ID # | 16151A |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 1, 2018 |
Est. completion date | December 2024 |
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 | Recruiting |
Enrollment | 24 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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). - 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 |
Country | Name | City | State |
---|---|---|---|
Australia | Monash Medical Centre | Clayton | Victoria |
Lead Sponsor | Collaborator |
---|---|
Monash Medical Centre |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Vocal cord aperture measured using continuous laryngoscopy after hyperventilation in normal subjects and asthmatics | 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. |
6 years | |
Secondary | Lung function indices after hyperventilation in normal and asthmatic patients. | 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. | 6 years | |
Secondary | Role of the extra-thoracic airway hyper-responsiveness measured using bronchial provocation test to identify asthma like symptoms. | Role of the extra-thoracic airway hyper-responsiveness to asthma like symptoms using Mannitol bronchial provocation testing | 6 years | |
Secondary | Vocal cord changes after anti-cholinergic inhalers and/or exercise. | 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. |
6 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04624425 -
Additional Effects of Segmental Breathing In Asthma
|
N/A | |
Terminated |
NCT04410523 -
Study of Efficacy and Safety of CSJ117 in Patients With Severe Uncontrolled Asthma
|
Phase 2 | |
Active, not recruiting |
NCT03927820 -
A Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmissions (PILLAR)
|
N/A | |
Completed |
NCT04617015 -
Defining and Treating Depression-related Asthma
|
Early Phase 1 | |
Recruiting |
NCT03694158 -
Investigating Dupilumab's Effect in Asthma by Genotype
|
Phase 4 | |
Terminated |
NCT04946318 -
Study of Safety of CSJ117 in Participants With Moderate to Severe Uncontrolled Asthma
|
Phase 2 | |
Completed |
NCT04450108 -
Vivatmo Pro™ for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in U.S. Asthmatic Patients
|
N/A | |
Completed |
NCT03086460 -
A Dose Ranging Study With CHF 1531 in Subjects With Asthma (FLASH)
|
Phase 2 | |
Completed |
NCT01160224 -
Oral GW766944 (Oral CCR3 Antagonist)
|
Phase 2 | |
Completed |
NCT03186209 -
Efficacy and Safety Study of Benralizumab in Patients With Uncontrolled Asthma on Medium to High Dose Inhaled Corticosteroid Plus LABA (MIRACLE)
|
Phase 3 | |
Completed |
NCT02502734 -
Effect of Inhaled Fluticasone Furoate on Short-term Growth in Paediatric Subjects With Asthma
|
Phase 3 | |
Completed |
NCT01715844 -
L-Citrulline Supplementation Pilot Study for Overweight Late Onset Asthmatics
|
Phase 1 | |
Terminated |
NCT04993443 -
First-In-Human Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of LQ036
|
Phase 1 | |
Completed |
NCT02787863 -
Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology
|
Phase 4 | |
Recruiting |
NCT06033833 -
Long-term Safety and Efficacy Evaluation of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study
|
Phase 2 | |
Completed |
NCT03257995 -
Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Two Orally Inhaled Indacaterol Salts in Adult Subjects With Asthma.
|
Phase 2 | |
Completed |
NCT02212483 -
Clinical Effectiveness and Economical Impact of Medical Indoor Environment Counselors Visiting Homes of Asthma Patients
|
N/A | |
Recruiting |
NCT04872309 -
MUlti-nuclear MR Imaging Investigation of Respiratory Disease-associated CHanges in Lung Physiology
|
||
Withdrawn |
NCT01468805 -
Childhood Asthma Reduction Study
|
N/A | |
Recruiting |
NCT05145894 -
Differentiation of Asthma/COPD Exacerbation and Stable State Using Automated Lung Sound Analysis With LungPass Device
|