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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)
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

Study 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.Check my eligibility
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.See study design
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 have had a chronic cough for over 8 weeks and it improved with asthma treatment.
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I am between 18 and 65 years old and have never had asthma or a chronic cough.

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
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.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mid expiratory flows
Secondary outcome measures
Central Airway Resistance
FEV1/FVC
Forced Vital Capacity (FVC)
+2 more

Trial Design

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

Find a Location

Who is running the clinical trial?

Dr. Diane LougheedLead Sponsor
1 Previous Clinical Trials
29 Total Patients Enrolled
1 Trials studying Cough Variant Asthma
29 Patients Enrolled for Cough Variant Asthma
M. Diane Lougheed, MD, MScPrincipal InvestigatorDepartment of Medicine, Queen's University

Media Library

Control Clinical Trial Eligibility Overview. Trial Name: NCT03105843 — Phase 4
Cough Variant Asthma Research Study Groups: Control, Methacholine-induced cough, Cough Variant Asthma
Cough Variant Asthma Clinical Trial 2023: Control Highlights & Side Effects. Trial Name: NCT03105843 — Phase 4
Control 2023 Treatment Timeline for Medical Study. Trial Name: NCT03105843 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are being enrolled in this experiment?

"Yes, the information on clinicaltrials.gov indicates that this trial is actively looking for patients to enroll. The trial was posted on March 1st, 2022 and updated April 18th, 2022. Only 30 patients are needed at one site."

Answered by AI

Are there any other similar studies that have been done on Eucapneic Voluntary Hyperventilation (EVH) and Hypertonic Saline (HS)?

"There is currently one clinical trial ongoing that is researching the effects of Eucapneic Voluntary Hyperventilation (EVH) and Hypertonic Saline (HS) Challenge Tests. This study is in Phase 3 with several more trials being conducted in Kingston, Ontario."

Answered by AI

Are researchers only looking for test subjects who are legal adults?

"The age limit for participants in this clinical trial is 65 years old. All patients that are hoping to enroll must be over the age of 18."

Answered by AI

Are patients still being accepted for enrollment in this research project?

"Yes, this information can be found on clinicaltrials.gov. The study was posted on March 1st and updated April 18th of this year."

Answered by AI

Are there any specific requirements to be a part of this research project?

"This trial is open to patients that have asthma and are between 18-65 years old. They are looking for around 30 participants in total."

Answered by AI

Do these two types of tests, Eucapneic Voluntary Hyperventilation and Hypertonic Saline Challenge Tests, have FDA approval?

"EVH and HS have both been approved, meaning that these challenge tests are safe."

Answered by AI
~3 spots leftby Jun 2024