Idiopathic Pulmonary Fibrosis
Conditions
Brief summary
The primary purpose is to evaluate the safety and efficacy of NAL ER for the treatment of chronic cough in participants with Idiopathic Pulmonary Fibrosis (IPF).
Interventions
DRUGNAL ER
Oral tablets
DRUGPlacebo
Oral tablets
Sponsors
Trevi Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of IPF as determined by the Investigator based on American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Society (ALAT) clinical practice guidelines. * Chronic cough for ≥8 weeks prior to Screening. * PGI-Severity Score ≥ 2 at Screening. * Forced vital capacity (FVC) ≥40 percent (%) of predicted at Screening. * Diffusing capacity for carbon monoxide (DLCO) ≥25% of predicted during Screening or within 12 weeks prior to Screening. * Participants who are currently taking antifibrotic medication (nintedanib, pirfenidone, nerandomilast) approved for IPF should be on a stable dose for at least 6 weeks prior to the Baseline Visit.
Exclusion criteria
* Clinical diagnosis or clinical suspicion of an upper or lower respiratory tract infection in the last 8 weeks prior to the Screening visit or during Screening. * Hospitalization for any respiratory illness (including acute exacerbation of IPF) within 2 months prior to Screening. Note: Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relative Change from Baseline in 24-hour Cough Frequency at Week 26 | Baseline, Week 26 |
Secondary
| Measure | Time frame |
|---|---|
| Absolute Change from Baseline in the Cough Severity Numerical Rating Scale (CS-NRS) at Week 26 | Baseline, Week 26 |
| Relative Change from Baseline in 24-hour Cough Frequency at Week 6 | Baseline, Week 6 |
| Percentage of Participants Achieving ≥50% Reduction from Baseline in 24-hour Cough Frequency at Week 26 | Baseline, Week 26 |
| Absolute Change from Baseline in the Evaluating Respiratory Symptoms in Idiopathic Pulmonary Fibrosis (E:RS-IPF) Cough Domain at Week 26 | Baseline, Week 26 |
| Percentage of Participants Achieving a ≥3-point Improvement from Baseline in CS-NRS at Week 26 | Baseline, Week 26 |
| Absolute Change from Baseline in the E:RS IPF Breathlessness Domain at Week 26 | Baseline, Week 26 |
| Relative Change from Baseline in 24-hour Cough Frequency | Baseline up to Week 54 |
| Absolute Change from Baseline in 24-hour Cough Frequency | Baseline up to Week 54 |
| Percentage of Participants Achieving ≥30%, ≥50% and ≥75% Reduction from Baseline in 24-Hour Cough Frequency | Baseline up to Week 54 |
| Absolute Change from Baseline in the E-RS:IPF Cough Domain | Baseline up to Week 54 |
| Absolute Change from Baseline in the E-RS:IPF Total Score and Domain Scores (IPF-Breathlessness, IPF-Cough, IPF-Sputum, and IPF-Chest Symptoms) | Baseline up to Week 54 |
| Absolute Change from Baseline in the CS-NRS | Baseline up to Week 54 |
| Percentage of Participants Achieving a ≥3-Point Improvement from Baseline in CS-NRS | Baseline up to Week 54 |
| Absolute Change from Baseline in the Leicester Cough Questionnaire (LCQ) Total Scores | Baseline up to Week 54 |
| Percentage of Participants Achieving a 1.3-Point Increase (Improvement) from Baseline in LCQ Total Score | Baseline up to Week 54 |
| Absolute Change from Baseline in Each LCQ Domain Score (Physical, Psychological, Social) | Baseline up to Week 54 |
| Change from Baseline in the European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) at Week 26 | Baseline, Week 26 |
| Relative Change from Baseline in Awake Cough Frequency | Baseline up to Week 54 |
| Relative Change from Baseline in Sleep Cough Frequency | Baseline up to Week 54 |
| Absolute Change from Baseline in the Patient Global Impression of Severity (PGI-S) Cough Score | Baseline up to Week 54 |
| Absolute Change from Baseline in the Patient Global Impression of Change (PGI-C) Cough Score | Baseline up to Week 54 |
| Percentage of Participants with Improvements by ≥1 and ≥2 Categories from Baseline on the PGI-S Cough | Baseline up to Week 54 |
| Safety and Tolerability as Assessed by Number of Participants with Treatment Emergent Adverse Events (TEAEs) | Up to Week 57 |
Countries
United States
Contacts
CONTACTPaula Buckley
STUDY_DIRECTORChief Development Officer
Trevi Therapeutics
Outcome results
None listed