Currently Recruiting Patients with chronic cough

due to Idiopathic Pulmonary Fibrosis

The CANAL Study

We are actively recruiting patients who suffer from chronic cough due to Idiopathic Pulmonary Fibrosis (IPF) to participate in the Cough And NALbuphine (CANAL) clinical research study.

CANAL evaluates the use of nalbuphine extended release tablets’ effect on cough frequency in those with IPF.

Target Enrollment

The Phase 2 CANAL Study will enroll approximately 60 subjects with chronic cough due to IPF.
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Study Visits

The CANAL Study consists of 10 study visits in total. This includes 6 on-site visits and 4 telephone visits.

United Kingdom Recruitment

The CANAL Study is actively recruiting at 11 sites in the United Kingdom.
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Study Design

This is a double-blind, randomized, placebo-controlled, 2-treatment, 2-period crossover efficacy and safety study in IPF subjects with nalbuphine ER tablets for the treatment of cough. The study consists of 2 treatment periods of 3 weeks, each followed by a washout period of 2 weeks.

Study Design

This is a double-blind, randomized, placebo-controlled, 2-treatment, 2-period crossover efficacy and safety study in IPF subjects with nalbuphine ER tablets for the treatment of cough. The study consists of 2 treatment periods of 3 weeks, each followed by a washout period of 2 weeks.

Do you have patients with chronic cough due to IPF?

Treatment Period 1: During Treatment Period 1, eligible subjects will be randomized (1:1) to one of the following treatment arms:

  • Arm 1: Active oral nalbuphine ER in Treatment Period 1 followed by crossover placebo in Treatment Period 2
  • Arm 2: Placebo in Treatment Period 1 followed by crossover oral nalbuphine ER in Treatment Period 2

Following 3 weeks of dosing in Treatment Period 1, subjects will complete a 2-week washout period before entering Treatment Period 2. Subjects assigned to Arm 1 will receive placebo and subjects assigned to Arm 2 will receive nalbuphine ER during Treatment Period 2. A final 2-week washout period will occur at the completion of Treatment Period 2.

Nalbuphine ER Dosing – Subjects on nalbuphine ER will have the dose titrated from 27 mg once daily (QD) to 54 mg twice-daily over a 5-day period and then maintained at 54 mg twice-daily for approximately 4 days. Doses will be subsequently titrated and maintained at 108 mg twice-daily over 1 week and then to 162 mg twice-daily over 6 days.

Do you have patients with chronic cough due to IPF?

Study Visits

There are 10 study visits in total for the CANAL Study. 6 of those visits will take place on-site and 4 will be by telephone.

On-Site Visits

Telephone Visits

Inclusion and Exclusion Criteria

Learn more about the CANAL Study’s key inclusion and exclusion criteria to see if you have patients that qualify.

Key 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.

Key Exclusion Criteria

  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. Currently on continuous oxygen therapy. History of substance abuse that, as determined by the Investigator, may interfere with the conduct of the study.

Get in Touch

Click the ‘CONTACT’ button to send an email to our team to learn more about the CANAL Study.

A member of our team will get back to you within 48-72 hours.