BridgeMD
New treatment option for Refractory Chronic Cough
Official title The Effect of Nalbuphine Extended-Release (NAL ER) on Cough in Participants With Refractory Chronic Cough (RCC)
ClinicalTrials.gov ID: NCT07671924
What this study is testing
What is NAL ER?
NAL ER is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for refractory chronic cough.
Also referred to as Nalbuphine.
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 purpose of this study is to evaluate the efficacy and safety of Nalbuphine ER Extended-release tablets for the treatment of participants with RCC.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Meets society guideline-based criteria for a diagnosis of RCC defined as:
- Insufficient improvement in cough after treatment for any identified cough-associated conditions.
- Unexplained cough for which an underlying condition has not been determined despite adequate investigation with diagnostic tests and trials of...
- 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...
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...
- History of bronchiectasis, chronic obstructive pulmonary disease (COPD) or idiopathic pulmonary fibrosis (IPF), or other significant respiratory...
- History of uncontrolled asthma defined as one of the following:
- ≥1 clinically significant exacerbation in the last 6 months, OR
- ≥2 clinically significant exacerbations in the past 12 months (a clinically significant asthma exacerbation is defined as requiring the use of...
See the full eligibility criteria
- Meets society guideline-based criteria for a diagnosis of RCC defined as:
- Insufficient improvement in cough after treatment for any identified cough-associated conditions.
- 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...
- 24-hour objective cough frequency ≥10 coughs/hour based on VitaloJAK® cough monitor recording performed during the Screening and Placebo Run-in Periods as well as a minimum recording duration of 20 hours suitable for...
- Forced expiratory volume in 1 second (FEV1) /forced vital capacity (FVC) ratio ≥ 60% as determined by spirometry adhering to American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines.
- 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:
- ≥1 clinically significant exacerbation in the last 6 months, OR
- ≥2 clinically significant exacerbations in the past 12 months (a clinically significant asthma exacerbation is defined as requiring the use of systemic corticosteroids).
- Current smoker or vaper or current use of tobacco smoke, cannabis smoke, or nicotine vaper.
- Individuals who have stopped smoking or vaping within the past 6 months, or those with \>20 pack-year smoking history.
- Current active tuberculosis or nontuberculous mycobacterial infection, a history of latent untreated tuberculosis, or a history of incompletely treated tuberculosis.
- Speech therapy/physiotherapy for RCC starting within 4 weeks of Baseline or during the study. Speech therapy/physiotherapy is acceptable if the participant has started the therapy more than 4 weeks prior to the Baseline...
- Known intolerance [gastrointestinal, central nervous system (CNS) symptoms], hypersensitivity, or drug allergy considered to be related to an opioid drug or known hypersensitivity to nalbuphine or to NAL ER excipients...
The study team makes the final eligibility decision.
Where it's taking place
- Burlington, Canada
- Québec, Canada
- Trois-Rivières, Canada
- Victoriaville, 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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Burlington, Canada; Québec, Canada; Trois-Rivières, Canada; Victoriaville, 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 ClinicalTrials.gov; the study team decides eligibility.