Sensory-Mechanical Responses to Eucapneic Voluntary Hyperventilation and Mannitol

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2026-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The objectives of this study are to determine the sensory-mechanical responses to Eucapneic Voluntary Hyperventilation (EVH) and Mannitol in individuals with cough variant asthma (CVA) and methacholine-induced cough with normal airway sensitivity (COUGH) and compare these responses to a control group of healthy individuals without asthma or chronic cough.

We hypothesize:

1. EVH and Mannitol cause dyspnea, cough, small airway obstruction with resultant dynamic hyperinflation, gas trapping and autoPEEP in individuals with CVA and COUGH, but not healthy controls.
2. The sensory-mechanical responses to both hyperosmolar challenges (EVH and Mannitol) are comparable within groups (CVA, COUGH and healthy controls).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Physiology of Cough in Asthma: Comparison of Sensory-Mechanical Responses to Mannitol and Methacholine Challenge Tests

NCT01064245

Asthma Cough Variant Asthma

COMPLETED NA

Bronchodilating and Bronchoprotective Effects of Deep Inspirations

NCT01659476

Asthma Cough

COMPLETED NA

Mannitol-Induced Cough Challenge in Healthy Controls and Subjects With Mild Allergic Asthma

NCT03620422

Asthma Cough

COMPLETED NA

The Effects of Salbutamol on Mannitol Induced Cough Responses in Healthy Controls

NCT04565847

Cough

COMPLETED PHASE2

The Effect of Deep Inhalation on Mannitol Responsiveness

NCT03505489

Asthma

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Asthma is a chronic respiratory condition characterized by eosinophilic airway inflammation. Individuals with classic asthma experience paroxysmal symptoms including cough, wheeze, shortness of breath and chest tightness. Cough variant asthma (CVA) is asthma in which chronic cough (cough lasting eight weeks or more) is the sole or predominant symptom of asthma. The pathophysiologic mechanisms which differentiate asthma, CVA, and eosinophilic bronchitis without asthma are not fully understood. We have recently identified individuals with chronic cough who cough during methacholine but have normal airway sensitivity (ie. do not have asthma or CVA) (COUGH) and may or may not have eosinophilic bronchitis. The purpose of this research is to further explore the pathophysiologic basis for cough in these conditions using two 'indirect' inhalation challenge tests: eucapneic voluntary hyperventilation (EVH) and Mannitol), which induce osmotic and/or temperature changes in airway. Specifically, this study will collect preliminary data on the sensory-mechanical responses of individuals with CVA, COUGH and healthy controls to EVH and Mannitol Challenges.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma Cough Cough Variant Asthma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cough Variant Asthma

Individuals diagnosed with Cough variant asthma

Group Type EXPERIMENTAL

Methacholine (MCh) Challenge Testing

Intervention Type DRUG

Visit 1: Informed consent, Baseline screening and pulmonary function tests and Low-dose methacholine challenge testing using partial and full flow-volume loops.

Eucapneic Voluntary Hyperventilation (EVH)

Intervention Type DIAGNOSTIC_TEST

Visit 2 or 3: Will be conducted in random order and subjects will perform one of the two challenge tests at either visit.

Mannitol Inhalation Kit

Intervention Type DRUG

Visit 2 or 3: Will be conducted in random order and subjects will perform one of the two challenge tests at either visit.

Methacholine-induced cough

Individuals with chronic cough and negative methacholine challenge

Group Type EXPERIMENTAL

Methacholine (MCh) Challenge Testing

Intervention Type DRUG

Visit 1: Informed consent, Baseline screening and pulmonary function tests and Low-dose methacholine challenge testing using partial and full flow-volume loops.

Eucapneic Voluntary Hyperventilation (EVH)

Intervention Type DIAGNOSTIC_TEST

Visit 2 or 3: Will be conducted in random order and subjects will perform one of the two challenge tests at either visit.

Mannitol Inhalation Kit

Intervention Type DRUG

Visit 2 or 3: Will be conducted in random order and subjects will perform one of the two challenge tests at either visit.

Control

Individuals with no history of asthma or chronic cough

Group Type EXPERIMENTAL

Methacholine (MCh) Challenge Testing

Intervention Type DRUG

Visit 1: Informed consent, Baseline screening and pulmonary function tests and Low-dose methacholine challenge testing using partial and full flow-volume loops.

Eucapneic Voluntary Hyperventilation (EVH)

Intervention Type DIAGNOSTIC_TEST

Visit 2 or 3: Will be conducted in random order and subjects will perform one of the two challenge tests at either visit.

Mannitol Inhalation Kit

Intervention Type DRUG

Visit 2 or 3: Will be conducted in random order and subjects will perform one of the two challenge tests at either visit.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Methacholine (MCh) Challenge Testing

Visit 1: Informed consent, Baseline screening and pulmonary function tests and Low-dose methacholine challenge testing using partial and full flow-volume loops.

Intervention Type DRUG

Eucapneic Voluntary Hyperventilation (EVH)

Visit 2 or 3: Will be conducted in random order and subjects will perform one of the two challenge tests at either visit.

Intervention Type DIAGNOSTIC_TEST

Mannitol Inhalation Kit

Visit 2 or 3: Will be conducted in random order and subjects will perform one of the two challenge tests at either visit.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

MCh[inhalation of sequential doubling doses of MCh(0.0625-16 mg/mL)] Provocholine Mannitol Challenge Test

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Individuals aged 18-65 years of age with CVA and individuals with methacholine-induced cough but normal airway sensitivity. The following definitions will be used:

1. CVA: chronic cough (≥8 weeks) is the sole or predominant symptom and positive methacholine challenge (PC20 ≤ 16 mg/mL) and history of cough responding to specific asthma treatment (such as inhaled steroid or 1 week trial of bronchodilator);
2. Methacholine-induced cough but normal airway sensitivity: chronic cough (≥8 weeks) is the sole or predominant symptom and negative methacholine challenges (PC20 \> 16 mg/mL).
* Individuals aged 18-65 years of age with no history of asthma or chronic cough.

Exclusion Criteria

* an exacerbation necessitating a change in medication, emergency department visit or hospitalizations within the previous 4 weeks
* inability to perform acceptable spirometry
* medical contraindications to methacholine challenge testing
* smoking history in excess of 10 pack years Note: Previous treatment with inhaled or systemic corticosteroids is not an exclusion criterion; medication use will be recorded and examined in the analysis.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes