Clinical Trial 42618

Cincinnati, OH 45242


Summary:

This study is being performed to find out if RTB101 is safe and whether it prevents clinically symptomatic respiratory illness that is either confirmed by laboratory test or not in people 65 years of age and older. RTB101 may prevent clinically symptomatic respiratory illnesses by improving the function of blood cells that fight infections. Improving the ability to fight infections is important in people age 65 and older because aging is associated with an increased risk of getting seriously sick from clinically symptomatic respiratory illnesses. In some very severe cases, clinically symptomatic respiratory illnesses can lead to death. To determine if RTB101 helps decrease the percentage and rate of clinically symptomatic respiratory illness associated with one or more laboratory-confirmed pathogens, such as respiratory viruses. To see if RTB101 decreases the duration of moderate and severe symptoms due to all respiratory illnesses that are confirmed with a laboratory test. To see if RTB101 is safe to use. To look at the rate of respiratory illnesses that occur with specific viruses. To determine whether RTB101 has any important benefit in the subjects’ use of various age-related health care resources (for example, number of trips to the Emergency Room [ER]) as well as their overall quality of life. Therefore, all subjects will be requested to complete a quality-of-life questionnaire as well as answer questions related to visits to an ER, Urgent Care Facility, or other type of facility to seek medical attention, including hospitalizations.


Qualified Participants Must:

• Must be 65 years of age or older
• Should require no or minimal assistance with self-care and activities of daily living
• Weighs at least 40kg
• Must not be a current smoker
• Must have less than a 10 pack year history
• Must not have anybody that currently smokes within their house
• Must not be diagnosed with (chronic obstructive pulmonary disease (COPD), emphysema, interstitial pulmonary fibrosis (IPF), Bronchiectasis, etc.)
• Must not have a history of a heart attack, coronary bypass surgery, or any percutaneous cornoary interventions within the last 6 months.
• Must not be diagnosed with congestive heart failure.
• Must not have unstable or life-threatining cardiac arrhythmia
• Must not have type 1 diabetes.
• Must not have a history of any systemic auto-immune diseases (lupus, inflammatory bowel disease, rhumatoid arthritis, etc.)
• Must not be receiving immunosuppressive therapy.


Qualified Participants May Receive:

Up to $810.00 over 9 visits.


Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.