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Recruiting Phase 3

Idiopathic Pulmonary Fibrosis (IPF)-Related Chronic Cough Reduction With Nalbuphine Extended-Release (NAL ER) Tablets

NCT07671911 · tracked via the Priya Life Science USA tracker
Phase
Phase 3
Started
2026-06-29
Last updated
2026-10-13

Condition(s) studied

Idiopathic Pulmonary Fibrosis

Investigational drug(s) / intervention(s)

NAL ER →Placebo

NAL ER: Oral tablets

Placebo: Oral tablets

Study 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).

Eligibility

Sex
ALL
Min age
40 Years
Max age
—
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/exclusion criteria may apply.

Primary outcome measure(s)

  • Relative Change from Baseline in 24-hour Cough Frequency at Week 26 — Baseline, Week 26

Trial sites (22)

FacilityCityRegionStatus
Newportnativemd, Inc. Newport Beach California Recruiting
Palmtree Clinical Research Palm Springs California Recruiting
Paradigm Clinical Research Centers, Inc. - Redding Redding California Recruiting
Critical Care Pulmonary and Sleep Associates (Ccpsa) - West Clinic Lakewood Colorado Recruiting
Meris Clinical Research Brandon Florida Recruiting
Clinical Research Specialists, Llc - Kissimmee Kissimmee Florida Recruiting
Pulmonary Specialists of The Palm Beaches Loxahatchee Groves Florida Recruiting
Clinical Research and Associates, Inc. Miami Florida Recruiting
Coastal Pulmonary & Critical Care, PLC St. Petersburg Florida Recruiting
Tulane Clinic New Orleans Louisiana Recruiting
Hannibal Regional Hospital Hannibal Missouri Recruiting
Renown Regional Medical Center - Center For Advanced Medicine B Reno Nevada Recruiting
Montefiore Medical Center The Bronx New York Recruiting
Clinical Research of Gastonia (CRG) Gastonia North Carolina Recruiting
Southeastern Research Center Winston-Salem North Carolina Recruiting
Clinical Research Associates of Central, PA, LLC DuBois Pennsylvania Recruiting
Anmed Medical Center Anderson South Carolina Recruiting
Horizon Clinical Research Group Cypress Texas Recruiting
El Paso Pulmonary Association, PA El Paso Texas Recruiting
Elevate Clinical Research Houston Texas Recruiting
Intermountain MedicalL Center- PulmonaryY and Critical Care Research Murray Utah Recruiting
Pulmonary Associates of Richmond Inc (Par) - West Broad Location Richmond Virginia Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07671911 on ClinicalTrials.gov ↗ ← All trials in the USA