Clinical Study
Testing a Study Drug CMTX-101 Combined with Inhaled Tobramycin in People with Cystic Fibrosis Who Also Have Pseudomonas Aeruginosa
This is a study to evaluate the new medication CMTX-101 in combination with inhaled Tobramycin in people with Cystic Fibrosis who also have Pseudomonas Aeruginosa. Cystic Fibrosis is a rare disease that mainly affects the lungs causing lung infections. Pseudomonas Aeruginosa is a type of bacteria (germ) that can cause infections in the body such as the lungs. Infections with Pseudomonas Aeruginosa are a leading cause of respiratory (breathing) failure and death in adults. The study will see if the drug will help people with the disease and is safe. People in the study will be treated with CMTX-101 in combination with inhaled Tobramycin. Being in the study requires about 35 days of participation. Including, 7 in-person visits at a study clinic and completing surveys. There are 2 parts of the study. People of part 1 will receive CMTX-101. People in part 2 will be randomly chosen to receive CMTX-101 or a placebo. The placebo looks like the drug but does not have the medication. People cannot be in both parts 1 and 2 of the study. Medical tests will be done during the study to track the health of participants.
For more information contact:
Judy Jensen
judy.jensen@hsc.utah.edu
8017035353
IRB#: IRB_00171828
| PI: Theodore Liou
| Department: PULMONARY
| Approval Date: 2023-12-21 07:00:00
Specialties: Pulmonary
Who can participate?
Gender: All
Age: Over 18 years old
Volunteers: Volunteers with special conditions
Location: In Person
Inclusion Criteria:
- Ages 18 and older
- Diagnosis of Cystic Fibrosis
- Diagnosis of Pseudomonas Aeruginosa
- Currently receiving at least a 28-day cycle of inhaled Tobramycin alone or a continuous alternating antipseudomonal therapy (a way to treat Pseudomonal respiratory (breathing) infections of people with Cystic Fibrosis) at least 8 weeks before participation
- Able to attend in person at a study clinic
Exclusion Criteria:
- Known or history of virus infections such as human immunodeficiency virus (HIV) infection or chronic Hepatitis B
- Test positive for Hepatitis C virus (HCV)
- Worsening of respiratory symptoms such as increased cough, shortness of breath
- Require constant oxygen support
- Pregnant
Will I be paid for my time?
Yes