COPD Research Study

In chronic obstructive pulmonary disease (COPD), activated neutrophils are key disease drivers as they release tissue-damaging neutrophil serine proteases (NSPs) that promote airway inflammation, mucus plugging, and exacerbations (i.e., symptom flare ups). Neutrophils are further increased during exacerbations. Hence, drugs that block or reduce NSPs have therapeutic potential for controlling COPD.

The COPD research study is evaluating an orally active, small molecule inhibitor of DPP1, the enzyme responsible for activating NSPs during neutrophil maturation. By inhibiting DPP1, the study drug may reduce NSP levels, lessen airway damage and mucus plugging, and potentially reduce the frequency and severity of COPD exacerbations.

Throughout the duration of the COPD research study, participants will continue their stable background COPD maintenance therapies.

The study team or your study doctor will explain what this means for you in detail.

COPD Research Study Inclusion Criteria

You may be eligible to participate if you:

• Are between 40 and 85 years old
• Have been diagnosed with COPD for at least 1 year
• Are a current or former tobacco smoker who smoked about 1 pack a day for 10 years (or the same, like 2 packs a day for 5 years).
  • Individuals who have never smoked tobacco are not eligible.
• Have chronic bronchitis symptoms, such as a persistent cough with mucus for at least 3 months in the past year
• Have been using a daily inhaler (either dual or triple therapy) for at least 3 months
• Have had flare-ups in the past 12 months even while taking your inhaler:
  1. 2 or more moderate flare-ups (needed antibiotics or steroid pills/injections)
  2. OR 1 severe flare-up (led to a hospital stay or ER visit longer than 24 hours)
• Have a BMI between 18.5 and 35

You may NOT be eligible if you:

• Have other lung problems like asthma, lung cancer, pulmonary fibrosis, cystic fibrosis, or active/untreated tuberculosis (TB)
  • Participants with a history of TB are eligible only if they have completed a full, documented course of treatment.
• Use supplemental oxygen more than 12 hours a day
• Had a COPD flare-up, pneumonia, or major infection in the last 4 weeks
• Are currently taking non-selective B-blocker medications (such as Propranolol/Inderal, Carvedilol/Coreg, Nadolol/Corgard, or Timolol eye drops)
• Are taking certain medications that affect the immune system
• Have medical conditions that could interfere with participation

**Additional inclusion/exclusion criteria may apply

Not sure if you qualify?
A member of our study team will review your medical history and medications with you to determine if this COPD research study may be a good fit for you.

You may also qualify for other studies.

Study Duration and Number of Visits

Approximately 56 weeks (about 1 year), including a 52-week treatment period

Study Visits

About 11 visits throughout the study

Study Procedure

Study procedures and assessments will include:

• Take a once-daily study pill (or placebo)
• Continue your current COPD medications as prescribed
• Regular check-ins to monitor breathing, symptoms, and overall health
  • Use of an electronic diary (eDiary) device or app to record symptoms.
• Routine health assessments, questionnaires, physical exams, and vital sign checks
• Lung function tests (spirometry), ECGs, and blood and urine sample collection

Compensation

Participants may receive compensation for time and travel (details will be shared by the study team)

More Details

If you have any other questions about what to expect from this COPD research study, feel free to ask the study team or your study doctor.