Clinical trial for Chronic Cough (CC)
Official title Mechanisms of Change in Behavioral Cough Suppression Therapy for Refractory Chronic Cough
ClinicalTrials.gov ID: NCT06960759
What this study is testing
What is BCS+active?
BCS+active is an investigational medicine, given as an inhaled treatment, being studied as a potential treatment for chronic cough (cc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing new ways to help people who have chronic cough that has not improved with typical treatments. One approach is called behavioral cough suppression (BCS) therapy, which teaches people techniques to stop themselves from coughing.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join if
- To be eligible to participate, participants must meet the following criteria:
- 18 - 99 years of age
- Diagnosis of refractory or unexplained chronic cough
- Normal chest imaging (x-ray or CT scan) within past 2 years, without change in cough symptoms
- If you a potential participant has asthma, the following criteria must be met:
You likely can't join if
- Any of the following will be grounds for exclusion from the study:
- Currently a smoker of any substance or has a positive history of smoking any substance within the last 6 months
- Currently suffering from any signs of an upper respiratory infection (other than cough)
- Hemoptysis (coughing up blood) within the last 6 months
- Pulmonary diagnosis other than asthma
- Asthma criteria - participant is deemed ineligible if screened for one or more of the following:
See the full eligibility criteria
- To be eligible to participate, participants must meet the following criteria:
- 18 - 99 years of age
- Diagnosis of refractory or unexplained chronic cough
- Normal chest imaging (x-ray or CT scan) within past 2 years, without change in cough symptoms
- If you a potential participant has asthma, the following criteria must be met:
- Asthma diagnosed by a pulmonary provider
- Documentation from a pulmonary provider that asthma is well-controlled
- Agree to carry prescribed rescue inhaler to each study visit
- Can tolerate, and agree to, avoid rescue inhaler use for 4 hours prior to each study visit. If rescue inhaler use is unavoidable within 4 hours of a study visit, agree to inform researchers in advance so that the...
- Normal pulmonary function testing with spirometry (FEV1/FVC of at least 70% if diagnosed with asthma) within 2 years (6 months for those with a diagnosis of asthma), without change in symptoms since (NOTE: spirometry is...
- Laryngoscopy or stroboscopy within 2 years without evidence of structural pathology and no change in vocal quality since exam
- Proficient reader/speaker of English
- Willing to take a pregnancy test before enrollment (if applicable)
- Willing to use contraception during the study (if applicable)
- Access to reliable internet, working email address (for surveys) and a smart phone (for use with CoughMonitor Watch)
- Demonstrates understanding in study procedures and risks in order to consent
- Available, and willing, to comply to all study procedures and clinic visits.
- Any of the following will be grounds for exclusion from the study:
- Currently a smoker of any substance or has a positive history of smoking any substance within the last 6 months
- Currently suffering from any signs of an upper respiratory infection (other than cough)
- Hemoptysis (coughing up blood) within the last 6 months
- Pulmonary diagnosis other than asthma
- Asthma criteria - participant is deemed ineligible if screened for one or more of the following:
- Use of rescue inhaler in response to active asthma symptoms ≥ 2 times per week
- Respiratory related emergency department visit within the past 4 weeks
- Respiratory related ICU admission within the past 12 months
- Asthma exacerbation requiring systemic corticosteroid use within the past 4 weeks
- Pregnant or trying to become pregnant
- Any complaints or clinical symptoms of dysphagia
- Live with someone with chronic cough or work with someone with chronic cough who is in close proximity (e.g., within 25 feet) on a daily or nearly daily basis
- Known allergy to peppers
- Currently receiving or has received BCS therapy for management of refractory chronic cough
- Excluded concomitant medications:
- Inhaled pulmonary medications (inhaled corticosteroids, short-acting beta agonists, long-acting beta-agonist, short-acting muscarinic antagonists), unless prescribed for asthma by pulmonary provider: 30 days prior to...
- ACE inhibitor (benazepril, captopril, enalapril, fosiniopril, lisinopril, perindopril, quinapril, ramipril, trandolapril): 30 days prior to Visit 1 through completion of study participation.
- Narcotic antitussive (hydrocodone, oxycodone, morphine, codeine, tramadol): 7 days prior to Visit 1 through completion of study participation
- Non-narcotic antitussive (benzonatate/Tessalon, dextromethorphan/Delsym, carbetapentane/Solotuss): 7 days prior to Visit 1 through completion of study
- P2X3 receptor antagonist (gefapixant/Lyfnua): 14 days prior to Visit 1 through completion of study
- Any off-label prescription medication prescribed for cough (pregabalin/Lyrica, gabapentin/Neurontin, amitriptyline/Elavil): 14 days prior to Visit 1 through completion of study \ if a neuromodulator is prescribed for...
- Presence of metal implants, devices or fragments (e.g., shrapnel) in the body
- Claustrophobia
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
- Atlanta, Georgia, United States
- Missoula, Montana, United States
Compensation & support
This study's listing mentions compensation or reimbursement.
No amount is published here - ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States; Atlanta, Georgia, United States; Missoula, Montana, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.