The Effect of Nalbuphine Extended-Release (NAL ER) on Cough in Participants with Refractory Chronic Cough (RCC) (LAKE)
EU CTIS ID: 2026-526087-20-00
What this study is testing
To evaluate the effect of NAL ER on 24-hour cough frequency (coughs per hour) at Week 6 using objective cough monitor
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Males or females ages 18 years and older at the time of consent.
- Written informed consent and authorization for release and use of protected health information.
- Meets society guideline-based criteria (Irwin, 2018) for a diagnosis of RCC defined as: a)insufficient improvement in cough after treatment for any identified cough-associated conditions, OR b) unexplained cough for which an underlying condition has not been determined despite adequate investigation with diagnostic tests and trials of therapy.
- Persistent and chronic cough for at least one year prior to Screening.
- Chest computed tomography (CT) or chest radiograph of the thorax performed within the last 24 months and after the onset of chronic cough OR the procedure completed by the Investigator during the Screening period, that does not show any abnormality considered to be significantly contributing to the RCC in the opinion of the Principal Investigator.
You likely can't join if
- Clinical diagnosis of sleep apnea and/or use of Continuous Positive Airway Pressure (CPAP).
- Upper or lower respiratory tract infection or change in pulmonary status in the 4 weeks prior to the Screening visit or during the Screening or PBO Run-in periods.
- History of bronchiectasis, chronic obstructive pulmonary disease (COPD) or idiopathic pulmonary fibrosis (IPF), or other significant respiratory disorder that might affect cough.
- History of uncontrolled asthma defined as one of the following: a. ≥1 clinically significant exacerbation in the last 6 months, OR b. ≥2 clinically significant exacerbations in the past 12 months (a clinically significant asthma exacerbation is defined as requiring the use of systemic corticosteroids)
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Canada
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 - 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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Canada. 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 EU CTIS; the study team decides eligibility.