NCT03105843 Sensory-Mechanical Responses to Eucapneic Voluntary Hyperventilation and Mannitol
| NCT ID | NCT03105843 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Dr. Diane Lougheed |
| Condition | Asthma |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2022-03-01 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 30 participants in total. It began in 2022-03-01 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
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.
Contact & Investigator
M. Diane Lougheed, MD, MSc
PRINCIPAL INVESTIGATOR
Department of Medicine, Queen's University
Frequently Asked Questions
Who can join the NCT03105843 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Asthma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03105843 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT03105843 currently recruiting?
Yes, NCT03105843 is actively recruiting participants. Contact the research team at diane.lougheed@kingstonhsc.ca for enrollment information.
Where is the NCT03105843 trial being conducted?
This trial is being conducted at Kingston, Canada.
Who is sponsoring the NCT03105843 clinical trial?
NCT03105843 is sponsored by Dr. Diane Lougheed. The principal investigator is M. Diane Lougheed, MD, MSc at Department of Medicine, Queen's University. The trial plans to enroll 30 participants.
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