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EVH + Mannitol for Cough Variant Asthma

Phase 4

Recruiting

Led By M. Diane Lougheed, MD, MSc

Research Sponsored by Dr. Diane Lougheed

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Individuals aged 18-65 years of age with CVA and individuals with 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)

Must not have

An exacerbation necessitating a change in medication, emergency department visit or hospitalizations within the previous 4 weeks

Inability to perform acceptable spirometry

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time frame of the methacholine challenge varies between individuals. at provocative dose/ventilation causing a 20% decline in fev1 (pd20 and pc20 respectively). on average, these occur about 15-25 minutes into the challenge test

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

Summary

This trial will help determine if Eucapneic Voluntary Hyperventilation (EVH) and Hypertonic Saline (HS) can help individuals with cough variant asthma (CVA) and methacholine-induced cough with normal airway sensitivity (COUGH).

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Participants may experience side effects such as difficulty breathing (dyspnea), increased coughing, potential small airway obstruction leading to trapped gas in the lungs during the challenges with EVH and Mannitol.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old and have had a stroke or cough caused by methacholine with normal airway sensitivity.

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

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I am between 18 and 65 years old and have never had asthma or a chronic cough.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I cannot perform a lung function test properly.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time frame of the methacholine challenge varies between individuals. at provocative dose/ventilation causing a 20% decline in fev1 (pd20 and pc20 respectively). on average, these occur about 15-25 minutes into the challenge test

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time frame of the methacholine challenge varies between individuals. at provocative dose/ventilation causing a 20% decline in fev1 (pd20 and pc20 respectively). on average, these occur about 15-25 minutes into the challenge test

This trial's timeline: 3 weeks for screening, Varies for treatment, and time frame of the methacholine challenge varies between individuals. at provocative dose/ventilation causing a 20% decline in fev1 (pd20 and pc20 respectively). on average, these occur about 15-25 minutes into the challenge test for reporting.