Cystic Fibrosis Clinical Trial
Official title:
CF Leukocyte Genes as Biomarkers for Novel Therapies
Verified date | March 2017 |
Source | National Jewish Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Presently, effectiveness of treatments for CF lung disease is judged by improvement in lung function (FEV1). However, in CF patients, FEV1 can range from severely decreased to normal, and improvements may occur slowly. Thus, clinical trials require many patients over prolonged periods to evaluate medications. As the pace of drug development accelerates, it is no longer possible to test all of the promising candidate therapies using conventional study designs. A sensitive technique for assessing lung inflammation has been developed which uses the expression of genes located in circulating blood cells. Mononuclear cells pass repeatedly through the blood vessels of the lung, and are exposed to many of the inflammatory products that are present in the airways. Over the past 4 years the investigators have identified a small group of candidate genes that are unregulated or downregulated in response to antibiotic treatment. The investigators now propose to prospectively test this method of quantifying lung inflammation in a large group of CF patients undergoing treatment of pulmonary exacerbations. Blood will be sampled before and after antibiotic treatment for a pulmonary exacerbation, and the relative change in gene expression will be compared to improvement in FEV1 and other clinical responses, to determine the utility of this method for use in studies. If successful, this technique could allow for a rapid and noninvasive method to gauge immediate effects by new treatments, and assist caregivers in determining optimal treatment strategies for the individual.
Status | Completed |
Enrollment | 60 |
Est. completion date | October 2012 |
Est. primary completion date | October 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Documented diagnosis of CF. 2. Age 18 years old or greater. 3. Presentation at the start of treatment for a pulmonary exacerbation of CF. 4. Ability to perform reproducible Pulmonary Function Tests. 5. Willingness to comply with study procedure and willingness to provide written consent. Exclusion Criteria: 1. Participation in an investigational drug study within one month of enrollment. 2. Presence of a condition or abnormality that, in the opinion of the Principal Investigator (PI), would compromise the safety of the patient or the quality of the data. |
Country | Name | City | State |
---|---|---|---|
United States | National Jewish Health | Denver | Colorado |
Lead Sponsor | Collaborator |
---|---|
National Jewish Health | Cystic Fibrosis Foundation Therapeutics |
United States,
Nick JA, Sanders LA, Ickes B, Briones NJ, Caceres SM, Malcolm KC, Brayshaw SJ, Chacon CS, Barboa CM, Jones MC, St Clair C, Taylor-Cousar JL, Nichols DP, Sagel SD, Strand M, Saavedra MT. Blood mRNA biomarkers for detection of treatment response in acute pu — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The Primary analysis is the change in expression of individual and combinations of mononuclear cell genes, obtained pre- and post-antibiotic therapy. | 14-21 days | ||
Secondary | Correlation of changes in PBMC gene expression with changes in FEV1 | 14-21 days | ||
Secondary | Correlation of changes in PBMC gene expression with changes in WBC counts. | 14-21 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04696198 -
Thoracic Mobility in Cystic Fibrosis Care
|
N/A | |
Completed |
NCT00803205 -
Study of Ataluren (PTC124™) in Cystic Fibrosis
|
Phase 3 | |
Terminated |
NCT04921332 -
Bright Light Therapy for Depression Symptoms in Adults With Cystic Fibrosis (CF) and COPD
|
N/A | |
Completed |
NCT03601637 -
Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Participants 1 to Less Than 2 Years of Age With Cystic Fibrosis, Homozygous for F508del
|
Phase 3 | |
Terminated |
NCT02769637 -
Effect of Acid Blockade on Microbiota and Inflammation in Cystic Fibrosis (CF)
|
||
Recruiting |
NCT06012084 -
The Development and Evaluation of iCF-PWR for Healthy Siblings of Individuals With Cystic Fibrosis
|
N/A | |
Recruiting |
NCT06032273 -
Lung Transplant READY CF 2: CARING CF Ancillary RCT
|
N/A | |
Recruiting |
NCT06030206 -
Lung Transplant READY CF 2: A Multi-site RCT
|
N/A | |
Recruiting |
NCT06088485 -
The Effect of Bone Mineral Density in Patients With Adult Cystic Fibrosis
|
||
Recruiting |
NCT05392855 -
Symptom Based Performance of Airway Clearance After Starting Highly Effective Modulators for Cystic Fibrosis (SPACE-CF)
|
N/A | |
Recruiting |
NCT04056702 -
Impact of Triple Combination CFTR Therapy on Sinus Disease.
|
||
Recruiting |
NCT04039087 -
Sildenafil Exercise: Role of PDE5 Inhibition
|
Phase 2/Phase 3 | |
Completed |
NCT04038710 -
Clinical Outcomes of Triple Combination Therapy in Severe Cystic Fibrosis Disease.
|
||
Completed |
NCT04058548 -
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
|
N/A | |
Completed |
NCT03637504 -
Feasibility of a Mobile Medication Plan Application in CF Patient Care
|
N/A | |
Recruiting |
NCT03506061 -
Trikafta in Cystic Fibrosis Patients
|
Phase 2 | |
Completed |
NCT03566550 -
Gut Imaging for Function & Transit in Cystic Fibrosis Study 1
|
||
Recruiting |
NCT04828382 -
Prospective Study of Pregnancy in Women With Cystic Fibrosis
|
||
Completed |
NCT04568980 -
Assessment of Contraceptive Safety and Effectiveness in Cystic Fibrosis
|
||
Recruiting |
NCT04010253 -
Impact of Bronchial Drainage Technique by the Medical Device Simeox® on Respiratory Function and Symptoms in Adult Patients With Cystic Fibrosis
|
N/A |