A Study of Nalbuphine (Extended Release) ER in Idiopathic Pulmonary Fibrosis (IPF) for Treatment of Cough

A Phase 2, Double-blind, Randomized, Placebo-controlled, Two-Treatment, Two-Period Crossover Efficacy and Safety Study in Idiopathic Pulmonary Fibrosis (IPF) With Nalbuphine ER Tablets for the Treatment of Cough

To evaluate the safety and tolerability of nalbuphine ER tablets in the study population and to evaluate the effect of NAL ER tablets on the mean daytime cough frequency (coughs per hour) at Day 22 (dose 162 mg BID) as compared to placebo tablets.

Inclusion Criteria:

1. Individuals diagnosed with Idiopathic Pulmonary Fibrosis
2. Chronic cough > 8 weeks.
3. Daytime cough severity score ≥ 4 on Cough Severity Numerical Rating Scale at screening.

Exclusion Criteria:

1. The following conditions are excluded:

   1. Interstitial lung disease (ILD) known to be caused by domestic and occupational environmental exposures.

   2. Interstitial lung disease (ILD) known to be caused by connective tissue disease.

   3. Interstitial lung disease (ILD) known to be caused by drug related toxicity.

      2. Currently on continuous oxygen therapy.

      3. History of substance abuse that, as determined by the Investigator, may interfere with the conduct of the study.