Lung Research Florida

Research Facility of Advanced Asthma Clinic | Broward Pulmonary & Sleep Specialists

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The GSK223977 Study: A GlaxoSmithKline Research & Development Limited Clinical Research Study to Evaluate an Investigational Drug for Bronchiectasis.

Protocol: GSK223977

954-520-7296 ext. 1

YOU MAY QUALIFY TO PARTICIPATE IN THIS STUDY IF YOU:

  • Are 18-85 years old.
  • Have a bronchiectasis diagnosis confirmed with chest computed tomography (CT).

THOSE WHO QUALIFY MAY RECEIVE:

  • Compensation for travel.
  • No-cost study-related care.
  • No-cost study drug.

To learn more or see if you qualify, contact us today:

Site Contact Information

Maria Gavides
Lung Research Florida / Broward Pulmonary & Sleep
10059 NW 1st Court, Plantation, FL 33324

954-520-7296 ext. 1
mariagavides@browardpulmonarysleep.com

ABOUT BRONCHIECTASIS.

Bronchiectasis is a condition where the airways in the lungs become stretched and damaged. This makes it hard to clear mucus properly, which can build up and cause coughing, lung infections, and breathing difficulties.

People with bronchiectasis can very easily get short of breath and get frequent chest infections. Receiving the right care and treatment can make people feel better and experience fewer health issues.

You can help us find it.

If you have been diagnosed with bronchiectasis, you may qualify to participate in a clinical study that is enrolling now. The information in this brochure will answer some of the questions you may have. Please talk to your doctor to learn more.

WHAT IS A CLINICAL RESEARCH STUDY?

Researchers conduct clinical studies, also known as clinical trials, to learn if an investigational medication is safe and effective for people who have certain health conditions. Clinical studies follow strict scientific standards and regulations to ensure they produce the best data for health care decision making and protect the participants.

ABOUT THIS STUDY

This is a phase 2 study to investigate the efficacy and safety of an investigational drug called GSK3862995B for the treatment of bronchiectasis. “Investigational” means that the study drug has not been approved by any regulatory bodies.

GSK3862995B is a protein (also called a monoclonal antibody) made in a laboratory and acts like proteins in our bodies that fight infections. It is thought that it will reduce airway inflammation which may protect the airways from further damage and improve breathing.

This clinical study aims to recruit 363 participants divided into three groups. You will be randomly assigned to one where you may receive:

  • Study Drug dosage level 1 OR
  • Study Drug dosage level 2 (higher than dosage level 1) OR
  • Placebo

A placebo looks like the study drug but contains no active ingredients. You have 3 out of 5 chances of being placed in a drug group.

You will receive a dose of study drug or placebo according to schedule. The number of doses you will receive (i.e., 4 or 3 or 2) will depend on the timing of your enrollment. Those who join the study earlier during the recruitment period will receive more doses than those who join later.

The study will consist of the following periods:

  • A 28-day Screening Period to make sure you qualify for the study.
  • A Treatment Period lasting up to 48 weeks where you will be randomly assigned to one of the 3 study groups. The duration will depend on whether you receive 2, 3, or 4 doses.
  • A 37-week Follow-Up Period where you will have some physical exams and lab tests.

BY THE NUMBERS

  • Time in Study: Between 61 to 89 weeks
  • Number of Participants: 363
  • Number of Clinic Visits: Approximately 15

WHAT ARE THE NEXT STEPS?

To join this study, you must read and sign an informed consent document to show that you understand the study and what is required. A study team member will explain the study’s procedures, possible benefits and risks, and answer any questions prior to you signing the form. You are also encouraged to talk to your doctor to help you decide if this research study is right for you.

GOOD TO KNOW!

  • Your safety and overall health are our priority.
  • If you decide to participate you are under no obligation to remain in the study. You may leave the study at any time for any reason.
  • Your private health information will be handled in a confidential manner.