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Cough Reduction in IPF with Nalbuphine ER
This is a multi-center randomized, double-blind, placebo-controlled, parallel, 4-arm study of nalbuphine ER (NAL ER). After meeting eligibility during the Screening Period, subjects will be randomized (1:1:1:1) to one of four treatment arms with placebo and increasing doses of nalbuphine ER. Each arm will be titrated to their fixed dose during the blinded 2-week Titration period followed by the 4-week Fixed Dose Period for a total of 6 weeks on drug.
For more information see the country specific approved websites: Germany, Netherlands, Poland, Spain, Italy, Chile: TheCoralTrial. com United Kingdom, Australia, Canada: CoralCoughTrial. com Turkey: please refer to the list of locations and reach out to the site directly.
Study details:
This is a multi-center randomized, double-blind, placebo-controlled, parallel, 4-arm study. After meeting eligibility during the Screening Period, subjects will be randomized (1:1:1:1) to one of four treatment arms. * Arm 1: Placebo.
* Arm 2: 27 mg nalbuphine ER. * Arm 3: 54 mg nalbuphine ER. * Arm 4: 108 mg nalbuphine ER.
Each arm will be titrated to their fixed dose during the blinded 2-week Titration period according to Table: Dosing Scheme, followed by the 4-week Fixed Dose Period for a total of 6 weeks on drug. Subjects will be taken off study drug at the end of the Fixed Dose Period and followed off treatment for an additional 2 weeks.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-02-06
Primary completion: 2025-04-01
Study completion finish: 2025-04-01
Study type
TREATMENT
Phase
PHASE2
Trial ID
NCT05964335
Intervention or treatment
DRUG: nalbuphine ER 27 mg
DRUG: Placebo
DRUG: nalbuphine ER 54 mg
DRUG: nalbuphine ER 108 mg
Conditions
- • Idiopathic Pulmonary Fibrosis
Find a site
Closest Location:
Austin Hospital
Research sites nearby
Select from list below to view details:
Austin Hospital
Heidelberg, Not Specified, Australia
Westmead Hospital
Westmead, Not Specified, Australia
Eastern Health-Box Hill Hospital
Box Hill, Not Specified, Australia
Concord Repatriation General Hospital
Concord, Not Specified, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: NAL ER 27 mg
| DRUG: nalbuphine ER 27 mg
|
EXPERIMENTAL: NAL ER 54 mg
| DRUG: nalbuphine ER 54 mg
|
EXPERIMENTAL: NAL ER 108 mg
| DRUG: nalbuphine ER 108 mg
|
PLACEBO_COMPARATOR: Placebo
| DRUG: Placebo
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Effect of NAL ER on 24-hour cough frequency (coughs per hour) | Relative change from Baseline in 24-hour cough frequency versus placebo | Week 6 |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Effect of NAL ER on the EXAcerbation of Chronic pulmonary disease Tool | Relative change from Baseline in the EXACT© question 2 at Week 6 versus placebo | Week 6 |
Safety and tolerability of NAL ER | Adverse event, vitals signs, ECGs, clinical laboratory tests, spirometry, physical examinations, Subjective Opiate Withdrawal Scale (SOWS) | Screening through 14 day post last dose |
24-hour cough frequency (Coughs per hour) | Relative change from Baseline in 24-hour cough frequency (coughs per hour) versus placebo • Proportion of responders with ≥30%, ≥50% and ≥75% reduction in the 24-hour cough frequency at Week 2, 4, and 6, for NAL ER compared with placebo. | Weeks 2, 4, 6 |
Awake cough frequency (Coughs per hour) | Relative change from Baseline in awake cough frequency (coughs per hour) versus placebo. | Weeks 2, 4, 6 |
Sleep cough frequency (Coughs per hour) | Relative change from Baseline in sleep cough frequency (coughs per hour) at versus placebo. | Weeks 2, 4, 6 |
EXACT© (EXAcerbation of Chronic pulmonary disease Tool) (EXAcerbation of Chronic pulmonary disease Tool) | Change from Baseline in the EXACT© question 2 compared with placebo. Proportion of EXACT© question 2 responders, with response defined as at least a one category improvement versus placebo. Change from Baseline in the EXACT© sub-domains and individual items versus placebo. | Weeks 1, 2, 3, 4, 5, 6 |
CS-NRS (Cough Severity Numerical Rating Scale) | Change from Baseline in the CS-NRS versus placebo. | Weeks 1, 2, 3, 4, 5, 6 |
LCQ© (Leicester Cough Questionnaire) | Change from Baseline in the LCQ© total score versus placebo. Proportion of LCQ© responders, with response defined as 1.3-point increase versus placebo | Week 6 |
L-IPF© (Living with Pulmonary Fibrosis Impacts Questionnaire) | Change from Baseline in the L-IPF© versus placebo. | Week 6 |
L-IPF© (Living with Pulmonary Fibrosis Symptoms Questionnaire) | Change from Baseline in the L-IPF© versus placebo. | Week 6 |
EQ-5D-5L™ | Change from Baseline in the EQ-5D-5L™ versus placebo. | Week 6 |
PGI-S Cough (Patient Global Impression of Severity for Cough) | 1 item measure rating the severity of cough past 7 days from No cough, Mild, Moderate or Severe | Weeks 2, 4, 6 |
PGI-S IPF (Patient Global Impression of Severity and Change for IPF) | 1 item measure rating the symptoms of IPF past 7 days from No symptoms, Mild, Moderate or Severe | Weeks 2, 4, 6 |
CGI-S, (Clinicians Global Impression of Severity) | A one-item measure evaluating severity of the condition. No Symptoms Mild Moderate Severe | Baseline and Week 6 |
PGI-C Cough; (Patient Global Impression of Change for Cough) | 1 item measure rating the symptoms of IPF. (past 7 days) * Much better * Moderately better * A little better * No change * A little worse * Moderately worse * Much worse | Weeks 2, 4, 6 |
PGI-C IPF (Patient Global Impression of Change in IPF symptoms) | 1 item measure rating the symptoms of IPF. (Past 7 days) * Much better * Moderately better * A little better * No change * A little worse * Moderately worse * Much worse | Weeks 2, 4, 6 |
CGI-C | A one-item measure evaluating change from the initiation of treatment on a seven point scale. 1. = Very much improved 2. = Much improved 3. = Minimally improved 4. = No change 5. = Minimally worse 6. = Much worse 7. = Very much worse | Week 6 |
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