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221 active trials for Cystic Fibrosis

Pharmacokinetics of Omadacycline in Cystic Fibrosis

The purpose of this study is to characterize the pharmacokinetics of intravenous and oral omadacycline in patients with cystic fibrosis.

Start: July 2021

Clinical Effort Against Smoke Exposure in Cystic Fibrosis

The study will test the feasibility, acceptability, and preliminary efficacy of a multi-component smoking cessation intervention tailored to the needs of caregivers of children with CF and delivered in clinical settings as part of routine CF care. The ultimate goal of this effort is to reduce the exposure of children and adolescents with CF to tobacco smoke.

Start: June 2021

A Study Evaluating the Long-Term Safety of Elexacaftor Combination Therapy

This study will evaluate the long-term safety and tolerability of elexacaftor (ELX)/tezacaftor (TEZ)/ ivacaftor (IVA) triple combination (TC) in subjects with cystic fibrosis (CF) who are homozygous for F508del.

Start: May 2020

Clinical Utility of the 1-minute Sit to Stand Test as a Measure of Submaximal Exercise Tolerance in Patients With Cystic Fibrosis During Acute Pulmonary Exacerbation

The aim of this study is to assess whether the 1 minute Sit to Stand (STS) test can be used as a measure of submaximal endurance during a pulmonary exacerbation of Cystic Fibrosis (CF) for patients in the acute care setting. We hypothesize that if the STS test is a valid measure of submaximal cardiovascular endurance, it will moderately correlate with 6 minute walk distance (6MWD).

Start: September 2019

Feasibility of a Mobile Medication Plan Application in CF Patient Care

This is a pilot, multicenter, prospective, randomized controlled study to evaluate the feasibility of an innovative medication adherence intervention utilizing a web-based, mobile medication management application [MedActionPlan® (MAP)] to encourage self-management by reinforcing adherence and education about treatment regimens in Participants with cystic fibrosis (CF) (ages 12 years and older). Outcomes of interest for this study are 1) feasibility of MAP in real-world setting which will be evaluated using patient/caregiver and clinician feedback regarding value, ease of use, and challenges with use, 2) effect of MAP on patient/caregiver knowledge and perception of medication use, 3) effect of MAP on adherence to inhaled and oral medications used in chronic management of CF. Preliminary data regarding outcomes on exacerbations, lung function, and health care system utilization (e.g., emergency department visits, hospitalization) will also be examined as part of this study.

Start: September 2018

The Impact of Patch Rx Technologies on Adherence to Vitamin and Trikafta Therapies in Patients With Cystic Fibrosis

This proposed pilot study will assess if the Patch Technology system will increase adherence in patients with cystic fibrosis followed at the UTHSCSA Cystic Fibrosis Center.

Start: January 2021

High Resolution Micro OCT Imaging

The purpose of this study is to learn about using the imaging to make images of the lungs and nose with the long-term goal of the research leading to potential treatments and new therapies for patients with cystic fibrosis.

Start: April 2016

Study of Peripherally Inserted Venous Catheters in Cystic Fibrosis Patients

According to the U.S. CF Foundation Patient Registry, more than 25% of children and 40% of adults were treated with intravenous (IV) antibiotics for flares of lung disease in 2016. Medication for these flares is often delivered through a peripherally inserted central catheter (PICC). Case series have identified important complications of PICCs in CF patients such as blood clots and infection. The frequency of PICC-associated blood clots in CF patients ranges from 2 to 8%. Catheter-related complications may interfere with completion of therapy and lead to repeated procedures and other complex medical treatments. In some cases PICC complications may discourage patients from accepting future courses of IV antibiotics. Therefore, it is very important to identify patient- and device-related factors that are linked with more frequent complications and to figure out ways to reduce these risks. Proposed risk factors fall into several broad categories. First are catheter-related factors; second are patient factors; and third are catheter-management factors. To date, no multicenter trial has carefully studied PICC complications in a large group of adult and pediatric CF patients from the time each catheter is placed to when it is removed. The main purpose of this study is to see whether the investigators can identify important factors in each of the three categories (patient, catheter, and catheter management) that are linked to various complications.

Start: November 2018

Oral Glucose Tolerance Testing Using Candy for Cystic Fibrosis

The study aims to determine if a popular dextrose candy alternative yields a similar glycemic curve compared to the standard oral Dextrose solution used in the Oral Glucose Tolerance Test.

Start: February 2021

G551D Observational Study- Expanded to Additional Genotypes and Extended for Long Therm Follow up (GOAL-e2)

The goal of this research study is to collect blood and urine samples from people who have either the R117H type of CF or the non-G551D gating type of CF to be kept for future research.We will also use some of the collected blood to measure the number of neutrophils.

Start: January 2014

Segmentation of Structural Abnormalities in Chronic Lung Diseases

Lung structural abnormalities are complex, time-consuming, and may lack reproducibility to evaluate visually on CT scans. The study's aim is to perform automated recognition of structural abnormalities in CT scans of patients with chronic lung diseases by using dedicated software.

Start: January 2008

A Prospective Study to Evaluate Biological and Clinical Effects of Significantly Corrected CFTR Function

This is a prospective, multi-center observational study. The study is designed to measure the clinical effectiveness of elexacaftor, tezacaftor and ivacaftor triple combination therapy (TCT) in people with one or more copies of the F508del mutation, study the effects of TCT across a number of CF disease manifestations, and collect specimens for future research. Subjects in the study will have one "before TCT" visit within 30 days before initiation of the therapy and five "after TCT" visits over a 24-month follow-up period. Most participating sites will be divided into sub-study groups; each sub-study group will have specific non-optional procedures conducted in addition to the "Core" procedures. Finally there are four optional procedures (pH pill, transient elastography, and nasal cell procurement) that will be offered to subjects at certain sites. The duration of participation for each subject is 25 months. NOTE: FDA is currently reviewing the New Drug Application (NDA) for the TCT. Study will not begin unless and until FDA approval is granted.

Start: October 2019

Magnetic Resonance Imaging and Neuro-Psychological Testing In Cystic Fibrosis

CF is a complex, inherited illness that can affect many organs of the body. The investigators have found that some patients with CF have reported more problems with memory than would be expected at their age and that patients appear to be using memory strategies to overcome memory loss. The investigators intend to objectively test memory and examine MRI images of the brain of patients with CF.

Start: September 2021

Xenon-129 Lung Magnetic Resonance Imaging: Study of Healthy Volunteers and Participants With Pulmonary Disease

Aim of this study is to evaluate image quality and reproducibility of Xenon-129 Magnetic Resonance Imaging (MRI) and to evaluate changes in lung structure and function in participants with cystic fibrosis (CF) and asthma compared to healthy controls using Xenon-129 MRI.

Start: August 2015

Initial and Chronic Methicillin Resistant Staphylococcus Aureus (MRSA) Infection in Cystic Fibrosis (CF)

This study aims to examine features of MRSA that are associated with chronic MRSA infection and bacterial persistence despite IV antibiotic therapy. Subjects are asked to expectorate sputum and complete CF symptom diaries both at beginning and end of IV therapy.

Start: July 2015

Effects of Metformin on Airway Ion Channel Dysfunction in Cystic Fibrosis-related Diabetes

The purpose of this study is to assess the efficacy of metformin to improve airway ion channel function in those with CF-related diabetes (CFRD)

Start: September 2021

Immune Profiles in CF Fungal Infection

This study is investigating the role of allergic (Th2) inflammation in patients with Cystic Fibrosis (CF) and history of fungal infection and/or Allergic Bronchopulmonary Aspergillosis. Little is known about fungal infection in CF and conflicting results exist on whether this results in worse lung function over time. There is concern that persistent fungal infection can result in worse clinical outcome measures in patients with CF. Also, it is unclear how ABPA develops, but may be related to the amount of fungus a patient with CF is infected with. This study looks at inflammatory patterns and allergic responses to fungal elements to help identify biomarkers and signs of allergic disease in fungally infected patients with CF.

Start: February 2021

Evaluation of ELX/TEZ/IVA in Cystic Fibrosis (CF) Subjects 2 Through 5 Years

This study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA) triple combination therapy in CF subjects 2 through 5 years of age.

Start: November 2020

Evaluation of Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are 6 Years of Age and Older

This study will evaluate the long-term safety, tolerability, efficacy, and pharmacodynamics of elexacaftor (ELX, VX-445) in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF).

Start: February 2020

Glycemic Monitoring in Cystic Fibrosis

Current guidelines on the diagnoses and management of cystic fibrosis (CF) related diabetes recommend treatment for diabetes based on diagnostic criteria derived from adults with type 2 diabetes. Increasing evidence supports treating early glucose abnormalities in cystic fibrosis patients to target CF specific outcomes, including lung function and nutrition (BMI-Body Mass Index). However, the criteria and timing of when to start insulin therapy in the 'prediabetic' state are unclear. A more accurate characterization of blood sugar variability in youth with and without CF will help the investigators better interpret continuous glucose monitor (CGM) findings in patients with CF prediabetes and diabetes and more accurately identify those individuals at greatest risk for disease progression.

Start: August 2014