man with symptoms who may qualify for a copd research study

COPD Research Study

Evaluating a Novel Mechanism to Reduce the Frequency and Severity of Moderate and Severe COPD Exacerbations
Benefits of Joining a Clinical Trial
  • Many studies include compensation for time and travel
  • Study related medication and care provided at no cost
  • Health insurance is not required
Gender
Male and Female
Ages
40-84
Status
Coming Soon
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Overview

COPD Research Study:

This study is researching a potential new once-daily pill for people living with chronic obstructive pulmonary disease (COPD). COPD is a long-term lung condition that can make it hard to breathe and may include symptoms like chronic cough, mucus production, and shortness of breath.

Researchers are evaluating an investigational medication designed to be longer acting, which may help improve breathing and reduce symptoms over time. One important benefit of this study is that participants can stay on their current COPD medications, with no need to stop or switch treatments.

Some participants in this study will receive a placebo, which looks like the study medication but does not contain active medicine. This helps researchers compare results and better understand how well the treatment works.

The goal of this COPD research study is to determine whether this once-daily treatment is safe, well-tolerated, and effective in improving symptoms for people with COPD.

Table of Contents

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About the Study

This study is a Phase 2, randomized, double-blind, placebo-controlled, parallel arm, 52-week study to assess efficacy, safety, tolerability, and pharmacokinetics of two doses of the study drug in participants with COPD.

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 for an orally active, small molecule inhibitor of DPP1 that may reduce NSP levels, lessen airway damage, mucus plugging, and COPD exacerbations.

Existing therapies for COPD, including bronchodilators and inhaled corticosteroids, primarily target symptoms and airway inflammation but do not address the underlying neutrophilic inflammation that leads to lung tissue destruction. DPP1 is the enzyme responsible for activating NSPs during neutrophil maturation in the bone marrow. By inhibiting DPP1, the study drug aims to reduce the activity of these proteases, potentially offering a mechanism to reduce the frequency and severity of 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.

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Who Can Join

COPD Research Study Inclusion Criteria

You may be eligible to participate if you:

  • Are between 40 and 84 years old
  • Have been diagnosed with COPD for at least 1 year
  • Have chronic bronchitis symptoms, such as a persistent cough with mucus for at least 3 months in the past year
  • Are a current or former smoker with a history of regular smoking
  • Have a BMI between 18.5 and 35
  • Have been on stable COPD treatment (such as inhalers) for at least 3 months

You may not be eligible if you:

  • Are taking certain medications that affect the immune system
  • Had COPD exacerbation within the 4 weeks prior to randomization
  • Have medical conditions that could interfere with participation
    • Moderate-to-severe renal impairment and/or end-stage renal disease
    • Any history of malignancy within the last 5 years with the exception of participants who have had basal cell carcinoma, localized squamous cell carcinoma of the skin, or in situ cervical carcinoma that has been treated and is considered cured.
    • Any major surgery scheduled for the duration of the trial
  • A female who is pregnant, breast-feeding, or intends to become pregnant during the planned course of the study.
  • Considered at risk of self-harm

*Other conditions 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.

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What to Expect

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 and questionnaires
    • Spirometry to measure lung function, performed preferably in the morning.
    • Standard 12-lead ECG recordings to monitor heart health.
    • Collection of blood and urine samples for clinical safety laboratory assessments.
    • Clinical outcome assessment questionnaires
    • Physical examinations and vital signs at each clinic visit.
    • Dental safety surveillance including a full oral exam by the Investigator at each visit.
  • Ongoing support and guidance from the study team

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.

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See if You Qualify.

To see if you qualify or to learn more, please complete the form

Frequently Asked Questions.

What is a Clinical Trial?

A clinical trial is a research study that evaluates new medications, devices, or treatment approaches to determine if they are safe and effective. Clinical trials help doctors and researchers develop better treatments for current and future patients. All studies follow strict safety guidelines and are carefully monitored.
Each clinical study has requirements for participants based on specific factors such as age, medical history and current health. The eligibility criteria in each study protocol are used to identify the volunteers best qualified to participate.
No. Study-related medications, tests, and medical visits are provided at no cost to you. Participation in a clinical trial should not require you to pay for study-related care.
Many studies provide compensation for time and travel. Compensation varies by study and will be explained before you decide to participate.
Health insurance is not required for most clinical trials. Study-related care is typically provided at no cost to you.
Participation is completely voluntary. You may choose to leave the study at any time, for any reason. Your decision will not affect your regular medical care or benefits.
Each study has specific eligibility criteria based on age, medical history, and other factors. The best way to find out if you qualify is to complete the eligibility form or speak with a research team member.
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