EVH + Mannitol for Cough Variant Asthma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand how two treatments, Eucapneic Voluntary Hyperventilation (EVH) and Mannitol, affect individuals with cough variant asthma (CVA) and those with a chronic cough triggered by methacholine. Researchers will compare their responses to those of healthy individuals without these conditions. The goal is to determine if these treatments cause breathing problems and coughing in the affected groups but not in healthy individuals. Those who have experienced a persistent cough for more than eight weeks, either from CVA or methacholine-triggered cough, may be suitable candidates for this study. As a Phase 4 trial, this research focuses on understanding how these already FDA-approved treatments can benefit more patients.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it mentions that previous treatment with inhaled or systemic corticosteroids is not an exclusion criterion. Your medication use will be recorded and examined during the study.
What is the safety track record for Eucapneic Voluntary Hyperventilation and Mannitol?
Research has shown that Eucapneic Voluntary Hyperventilation (EVH) and hypertonic saline tests are generally safe for studies. These tests might cause a cough in some people but are usually well-tolerated. Past studies have used these methods to help diagnose asthma and other breathing issues without major safety concerns.
Methacholine challenge testing, another part of this study, is a common way to check for asthma. It involves inhaling a substance that can temporarily narrow the airways, aiding in the diagnosis of breathing problems. Previous patients demonstrated that this method is safe, though it may cause mild coughing or shortness of breath for a short time.
Both tests have been used in clinical settings and are considered safe for research. They mimic asthma symptoms, allowing doctors to better understand and treat breathing conditions. For those considering joining a trial with these tests, the risk of serious side effects is low based on available data.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about Eucapneic Voluntary Hyperventilation (EVH) and Hypertonic Saline (HS) challenge tests for Cough Variant Asthma because these approaches offer a fresh perspective on diagnosing and understanding asthma-related coughs. Unlike standard treatments that typically involve inhaled corticosteroids or bronchodilators, these tests focus on assessing airway responsiveness, which can provide deeper insights into how coughs are triggered and managed. By using hypertonic saline and hyperventilation as triggers, these methods might help identify underlying mechanisms specific to Cough Variant Asthma, potentially leading to more personalized and effective treatment strategies in the future.
What evidence suggests that this trial's treatments could be effective for cough variant asthma?
Research has shown that certain tests can effectively detect airway sensitivity in people with asthma, including cough variant asthma (CVA). In this trial, participants with CVA will undergo tests such as the Eucapneic Voluntary Hyperventilation (EVH) and Hypertonic Saline (HS) Challenge Tests. These tests have demonstrated that 84% of people with asthma had a strong reaction to a test using salty water, while healthy individuals had only a minor reaction. Another group in the trial will undergo Methacholine (MCh) Challenge Testing, which helps identify CVA by causing the airways to narrow, confirming asthma-like symptoms in those who mainly experience a cough. These methods are valuable for assessing and diagnosing different types of asthma by showing how the airways respond to specific challenges.34678
Who Is on the Research Team?
M. Diane Lougheed, MD, MSc
Principal Investigator
Department of Medicine, Queen's University
Are You a Good Fit for This Trial?
This trial is for adults aged 18-65 with cough variant asthma or chronic cough due to methacholine-induced cough but normal airway sensitivity. It's also open to healthy individuals without a history of asthma or chronic cough. People can't join if they've had a recent exacerbation, can't do proper lung function tests, have conditions that make the methacholine test unsafe, or have smoked heavily.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Challenge Testing
Participants undergo eucapneic voluntary hyperventilation (EVH) and Mannitol challenges to assess sensory-mechanical responses
Follow-up
Participants are monitored for safety and effectiveness after challenge tests
What Are the Treatments Tested in This Trial?
Interventions
- Eucapneic Voluntary Hyperventilation (EVH) and Hypertonic Saline (HS) Challenge Tests
- Methacholine (MCh) Challenge Testing
Trial Overview
The study aims to understand how people with certain types of coughs and healthy controls respond to two different stimuli: breathing exercises (EVH) and Mannitol inhalation. Researchers want to see if these cause symptoms like shortness of breath and whether there are differences in lung mechanics between groups.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Individuals with chronic cough and negative methacholine challenge
Individuals diagnosed with Cough variant asthma
Individuals with no history of asthma or chronic cough
Find a Clinic Near You
Who Is Running the Clinical Trial?
Dr. Diane Lougheed
Lead Sponsor
Dr. Diane Lougheed
Lead Sponsor
Citations
Inhalational challenge using hypertonic saline in asthmatic ...
In normal subjects the FEV1 was reduced by 6 +/- 2% (mean +/- SD) after inhalation of 33 ml of aerosol. Eighty four percent of the asthmatic subjects exhibited ...
Exercise and other indirect challenges to demonstrate ...
This article reviews and describes the symptom-based diagnosis, the exercise challenge, and other indirect challenges such as eucapnic voluntary hyperpnea.
Eucapnic Voluntary Hyperpnea: Gold Standard for ...
This article provides a state-of-the-art review of EVH, including an overview of the test methodology and its interpretation.
Indirect airway challenges | European Respiratory Society
A reduction in FEV1 of 10% of the pre-exercise value is widely accepted as outside the response observed in healthy individuals without asthma. Eucapnic ...
5.
researchgate.net
researchgate.net/publication/7905272_Methods_for_Indirect_Challenge_Tests_Including_Exercise_Eucapnic_Voluntary_Hyperpnea_and_Hypertonic_Aerosols(PDF) Methods for "Indirect" Challenge Tests Including ...
Eucapnic voluntary hyperpnea was developed later, as a surrogate test for exercise. Hypertonic aerosols were introduced to mimic the dehydrating ...
Cough response to isocapnic hyperpnoea of dry air and ...
We investigated whether there is an association between cough response induced by IHDA and hypertonic saline (HS) challenges.
EVH + Mannitol for Cough Variant Asthma
The objectives of this study are to determine the sensory-mechanical responses to Eucapneic Voluntary Hyperventilation (EVH) and Mannitol in individuals ...
Utility of Cough Provocation Tests in Chronic Cough and ...
... eucapnic voluntary hyperventilation, and hypertonic saline. The ... Investigating the safety of capsaicin cough challenge in severe asthma.
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