About The Study
Disease target: Chronic cough in Idiopathic Pulmonary Fibrosis (IPF)
Duration:
- Duration of study for each participant – up to 12 weeks
- Duration of treatment for each participant – up to 6 weeks
Recruitment target: Approximately 160 patients
Study Locations
WA
- TrialsWest
NSW
- Westmead Hospital
- Concord Repatriation General Hospital
VIC
- Eastern Health-Box Hill Hospital
- Austin Hospital
SA
- Respiratory Clinical Trials Pty Ltd.
What is involved?
Nalbuphine Extended-Release tablets (NAL ER) are being studied to treat cough in people who have idiopathic pulmonary fibrosis, which is also called IPF. IPF is a serious lung condition that affects breathing and approximately 85% of these patients experience a chronic cough. There is some research showing that other medicines similar to NAL ER may help reduce cough but there are currently no approved treatments.
The purpose of this study is to understand oral NAL ER tablets safety and to find the best dose of NAL ER to treat cough in people with IPF. 3 out of every 4 participants will take varying doses of NAL ER and 1 out of every 4 participants will take placebo.
A non-invasive cough monitor will be worn for 24 hours to objectively record the number of coughs and assess whether there is any change in the number of coughs while taking the study drug. During the 6 weeks of treatment, participants will return to the site for assessments approximately every 2 weeks.
Investigational medicinal product, comparator and randomisation
- Nalbuphine Extended-Release tablets (NAL ER)
- Participants will be randomised (1:1:1:1) to either one of three NAL ER arms or placebo.
- BID dosing will consist of 2 tablets from matching placebo and the available strengths, to meet the desired dose.
Can I participate?
Inclusion Criteria
- Diagnosis of IPF
- Cough Severity Score ≥ 4 on CS-NRS (Cough Severity Numerical Rating Scale)
- History of chronic cough for at least 8 weeks before screening.
- SpO2 ≥ 92% (Saturation of Hemoglobin with Oxygen as Measured by Pulse Oximetry).
- FVC ≥ 40% predicted of normal – Force Vital Capacity, as determined by spirometry.
- DLCO ≥ 25% predicted of normal – Diffusing capacity of the lung for carbon monoxide within the last 12 weeks, or at the time of screening.
- Males or females ages 18 years and older at the time of consent.
Exclusion Criteria
- Cannot currently be on continuous oxygen therapy for longer than 16 hours at any level or delivered by any modality. Intermittent oxygen use of any duration over any given 24-hour period is allowed.
- Cannot have had upper or lower respiratory tract infection in the last 8 weeks prior to the baseline visit.
- Cannot have clinical history of aspiration pneumonitis.
- Cannot have diagnosis of sleep apnea.
- Use of opiates including opiate-containing anti-cough agents, and naltrexone, benzodiazepines, and Monoamine oxidase inhibitors (MAOIs) are prohibited (washout permitted if clinically appropriate).
- Oral corticosteroid cough treatment must be stopped 4 weeks prior to the baseline visit and for the duration of the study.
- Medications prescribed as cough suppressants must be taken on a stable dose 14-days prior to the baseline visit and expected to remain on that dose for the duration of the study.
- CORAL Trial Summary CORAL-PACT-Trial-Summary.pdf
Further information or how to take part
If you would like to take part or have any questions about this research study, please fill out our Patient Trial Enquiry Form or email enquiries@pactnetwork.com.au.
This study is sponsored by Trevi Therapeutics.
Clinicaltrials.gov ID: NCT05964335