Chronic Cough study: BCS+inactive vs BCS+active
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?
This is an investigational combination of behavioral therapy and an inhaled substance being studied for chronic cough. It is designed to teach cough suppression techniques while using an inhaled substance to reduce the sensitivity of sensory nerves to cough triggers.
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
- The study aims to see how the therapies change cough sensitivity, control, brain response, and quality of life.
- Who it's for
- Adults with refractory chronic cough who can attend 14 clinic visits and two online visits.
- What's involved
- Participants receive behavioral cough suppression training, plus either an active or inactive inhaled treatment, or no treatment. They undergo cough tests, monitoring, and brain scans.
- Time commitment
- The study lasts about 6 months, with 14 clinic visits and two online visits for the treatment groups, and baseline testing for the control group.
- 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
- 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
- Asthma diagnosed by a pulmonary provider
- Documentation from a pulmonary provider that asthma is well-controlled
You likely can't join if
- 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
- Use of rescue inhaler in response to active asthma symptoms ≥ 2 times per week
- Respiratory related emergency department visit within the past 4 weeks
See the full eligibility 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
- 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.
- 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
- 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
- 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
- Presence of metal implants, devices or fragments (e.g., shrapnel) in the body
- Claustrophobia
The study team makes the final eligibility decision.
Where it is enrolling
- Atlanta, Georgia, United States
- Missoula, Montana, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, but 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?
This study is enrolling now at Atlanta, Georgia, United States; Missoula, Montana, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.