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Recruiting NCT07671911

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

Phase III Interventional Idiopathic Pulmonary Fibrosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: NAL ER, Placebo.
Who it may be relevant to
Registry conditions: Idiopathic Pulmonary Fibrosis. Basic parameters: from 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Nalbuphine Extended-Release Tablets for the Treatment of Chronic Cough in Participants With Idiopathic Pulmonary Fibrosis

Overview

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

  • Drug NAL ER
    Oral tablets
  • Drug Placebo
    Oral tablets

Primary outcome measures

  • Relative Change from Baseline in 24-hour Cough Frequency at Week 26 [Time frame: Baseline, Week 26]
Secondary outcome measures (12)
  • Absolute Change from Baseline in the Cough Severity Numerical Rating Scale (CS-NRS) at Week 26 [Time frame: Baseline, Week 26]
  • Relative Change from Baseline in 24-hour Cough Frequency at Week 6 [Time frame: Baseline, Week 6]
  • Percentage of Participants Achieving ≥50% Reduction from Baseline in 24-hour Cough Frequency at Week 26 [Time frame: Baseline, Week 26]
  • Absolute Change from Baseline in the Evaluating Respiratory Symptoms in Idiopathic Pulmonary Fibrosis (E:RS-IPF) Cough Domain at Week 26 [Time frame: Baseline, Week 26]
  • Percentage of Participants Achieving a ≥3-point Improvement from Baseline in CS-NRS at Week 26 [Time frame: Baseline, Week 26]
  • Absolute Change from Baseline in the E:RS IPF Breathlessness Domain at Week 26 [Time frame: Baseline, Week 26]
  • Relative Change from Baseline in 24-hour Cough Frequency [Time frame: Baseline up to Week 54]
  • Percentage of Participants Achieving ≥30%, ≥50% and ≥75% Reduction from Baseline in 24-Hour Cough Frequency [Time frame: Baseline up to Week 54]
  • Absolute Change from Baseline in the E-RS:IPF Cough Domain [Time frame: 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) [Time frame: Baseline up to Week 54]
  • Absolute Change from Baseline in the CS-NRS [Time frame: Baseline up to Week 54]
  • Percentage of Participants Achieving a ≥3-Point Improvement from Baseline in CS-NRS [Time frame: Baseline up to Week 54]

Eligibility criteria

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 (e.g., nintedanib, pirfenidone, nerandomilast) 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.
  • Diagnosed sleep apnea or currently on any treatment for sleep apnea \[example (e.g.), Continuous Positive Airway Pressure (CPAP)\].

Note: Other protocol-defined inclusion/exclusion criteria may apply.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 5 centers
  • Pulmonary Specialists of The Palm Beaches — Loxahatchee Groves
  • Clinical Research and Associates, Inc. — Miami
  • Clinical Research of Gastonia (CRG) — Gastonia
  • El Paso Pulmonary Association, PA — El Paso
  • Elevate Clinical Research — Houston

Identifiers

NCT: NCT07671911 · NAL03-301 · 2026-525877-38-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗