Refractory Chronic Cough study: NAL ER
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 oral tablet being studied for the treatment of 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 study aims to find out if Nalbuphine ER is effective and safe for treating refractory chronic cough.
- Who it's for
- People who have refractory chronic cough.
- 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
- 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...
- 24-hour objective cough frequency ≥10 coughs/hour based on VitaloJAK® cough monitor recording performed during the Screening and Placebo Run-in...
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...
- ≥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...
- Current smoker or vaper or current use of tobacco smoke, cannabis smoke, or nicotine vaper.
See the full eligibility criteria
- 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.
- ≥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 is enrolling
- Kelowna, British Columbia, Canada
- Toronto, Ontario, Canada
- Ajax, Canada
- Burlington, Canada
- Montreal, Canada
- North Van Couver, Canada
- Québec, Canada
- Saint-Charles-Borromée, Canada
- Trois-Rivières, Canada
- Victoriaville, Canada
- Belfast, United Kingdom
- Bristol, United Kingdom
- Cottingham, United Kingdom
- Harrow, United Kingdom
- Leicester, United Kingdom
- London, United Kingdom
- Manchester, United Kingdom
- North Somerset, United Kingdom
- Thetford, United Kingdom
- Tyne and Wear, United Kingdom
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Kelowna, British Columbia, Canada; Toronto, Ontario, Canada; Ajax, Canada; Burlington, Canada; Montreal, Canada; North Van Couver, Canada and 14 more locations. 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.