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Compensation: Varies

Number of Visits: 2

30 Participants Needed

EVH + Mannitol for Cough Variant Asthma

Overseen ByM. Diane Lougheed, MD, MSc

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Dr. Diane Lougheed

Disqualifiers: Recent exacerbation, Spirometry inability, Methacholine contraindications, Smoking, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

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 data supports the effectiveness of the treatment Eucapneic Voluntary Hyperventilation (EVH) and Hypertonic Saline (HS) Challenge Tests for Cough Variant Asthma?

Research suggests that Eucapneic Voluntary Hyperventilation (EVH) is a sensitive method for assessing airway hyperreactivity in asthma, correlating well with asthma symptoms. Indirect challenge tests like EVH and hypertonic saline are specific for asthma and help confirm the condition, making them valuable for understanding and monitoring airway function.¹ ² ³ ⁴ ⁵

Is the combination of EVH and Mannitol safe for humans?

Eucapnic voluntary hyperventilation (EVH) and mannitol have been used in tests to identify asthma and exercise-induced breathing issues, and they are generally considered safe for these purposes. Mannitol, in particular, has been shown to be a sensitive and specific test for airway responsiveness, suggesting it is safe for use in humans.⁵ ⁶ ⁷ ⁸ ⁹

How does the EVH + Mannitol treatment differ from other treatments for cough variant asthma?

The EVH + Mannitol treatment is unique because it combines eucapnic voluntary hyperpnea (EVH), which mimics exercise to provoke asthma symptoms, with mannitol, a dry powder that acts as an indirect challenge to identify airway hyper-responsiveness. This combination provides a more sensitive and practical way to assess and monitor asthma compared to traditional methods, which often require more complex and expensive equipment.⁵ ⁸ ⁹ ¹⁰ ¹¹

What is the purpose of this trial?

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).

Research Team

M. Diane Lougheed, MD, MSc

Principal Investigator

Department of Medicine, Queen's University

Eligibility Criteria

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

I have had a chronic cough for over 8 weeks and it improved with asthma treatment.

I have had a cough for over 8 weeks and passed a specific breathing test.

Exclusion Criteria

I cannot perform a lung function test properly.

I've had a health issue in the last month that required changing my medication or a hospital visit.

You have medical reasons that make it unsafe for you to do the methacholine challenge test.

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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Challenge Testing

Participants undergo eucapneic voluntary hyperventilation (EVH) and Mannitol challenges to assess sensory-mechanical responses

1-2 weeks

2-3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after challenge tests

4 weeks

Treatment Details

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.

Participant Groups

3Treatment groups

Experimental Treatment

Group I: Methacholine-induced coughExperimental Treatment3 Interventions

Individuals with chronic cough and negative methacholine challenge

Group II: Cough Variant AsthmaExperimental Treatment3 Interventions

Individuals diagnosed with Cough variant asthma

Group III: ControlExperimental Treatment3 Interventions

Individuals with no history of asthma or chronic cough