Do You Have COPD? Join a New Medication Study

A research study involving human subjects is designed to answer specific questions about the safety and/or efficacy of an intervention (drug, treatment, device, or other products), or new ways of using a known drug, treatment, device, or product before or during an investigational drug or product is made available to the public.

There are common assessments that are performed during most clinical studies. Here is what you can expect during this study:

1. Read and sign the Informed Consent Form (ICF)

• The ICF explains the study in more detail. The study doctor will explain the information in the ICF and answer any questions. 
• You must sign the ICF before receiving any study treatment or assessments. 
• Remember that taking part in the study is your choice. You can stop at any time. 

2. Confirm that you can join the study

Participants who would like to join the study will undergo screening to ensure they are a good fit. Study assessments/procedures may include: 

• Demographics: You will be asked to provide personal information, including date of birth, gender, ethnic origins, and race. 
• Medical History: You will be asked about your past and present health conditions, including COPD. You must provide accurate and complete information about your medical history and present health conditions. 
• Physical Exam: You will have physical examinations and tests, including COVID test, urine samples, lung function (spirometry) tests, and blood tests, among others.  

3. Health Assessments and Monitoring

At scheduled visits, the research team will:

• Perform physical exams, check vital signs, and record your medical history
• Collect blood samples for safety labs, drug levels, and immune system monitoring
• Conduct spirometry (breathing tests) to assess lung function
• Monitor your eosinophil levels (a type of white blood cell linked to inflammation)
• Ask you to complete questionnaires about your COPD symptoms and quality of life (including CAT, SGRQ-C, and mMRC scales)
• Review any adverse events or changes in your medications

Columbus, GA Office:

• Address: 4621 River Road, Columbus, GA 31904
• Principal Investigator: Dr. Anthony Olofintuyi

Study Duration

• The total duration is approximately 52 weeks (1 year).
• You will receive 2 injections of either the investigational drug or a placebo, spaced 12 weeks apart.

Study Visits

• You will be asked to attend up to 17 on-site visits at the study clinic.
• Visits are spaced throughout the study and include:
  • Screening visit to determine eligibility
  • Dosing visits on Day 1 and Day 84
  • Follow-up visits after each dose to monitor your health

Some visits may last several hours due to the assessments performed before and after dosing. For your safety, you’ll be monitored for at least 4 hours after each injection.

No, you do not have to pay to participate in a clinical study.

• It does not cost participants any money to join this clinical study, and they do not need health insurance to join.
• The study-related treatment and study visits will be of no cost to participants or their insurance companies.

Yes. You may decide to stop taking part in the study at any time and without providing any reason.