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Sponsors and Collaborators: |
National Jewish Health Cystic Fibrosis Foundation |
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Information provided by: | National Jewish Health |
ClinicalTrials.gov Identifier: | NCT00727285 |
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.
Condition |
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Cystic Fibrosis Pulmonary Exacerbation |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | CF Leukocyte Genes as Biomarkers for Novel Therapies |
Estimated Enrollment: | 60 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | October 2010 |
Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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A
CF patients followed by the Adult CF Program at National Jewish Health meeting criteria for an acute pulmonary exacerbation.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
CF patients followed by the Adult CF Program at National Jewish Health, who are ≥ 18 years and present with signs and symptoms of an acute pulmonary exacerbation. All subjects will be treated with at least two pathogen specific I.V. antibiotics for a minimum of 10 days, along with standard guidelines for other aspects of care for an acute pulmonary exacerbation. Concomitant use of inhaled antibiotics and systemic steroids will be allowed, and typical co-infections or co-morbidities will not result in exclusion.
Inclusion Criteria:
Exclusion Criteria:
Contact: Connie Pickard, R.N. | 3033981265 | pickardc@njc.org |
Contact: Marion Jones, R.N. | 3033981265 | jonesm@njc.org |
United States, Colorado | |
National Jewish Health | Recruiting |
Denver, Colorado, United States, 80206 | |
Contact: Connie Pickard, R.N. 303-398-1265 pickard@njc.org | |
Principal Investigator: Jerry A Nick, M.D. | |
Sub-Investigator: Milene T Saavedra, M.D. |
Principal Investigator: | Jerry A Nick, M.D. | National Jewish Health |
Responsible Party: | National Jewish Health ( Jerry A. Nick/Principal Investigator ) |
Study ID Numbers: | NICK07A0 |
Study First Received: | July 28, 2008 |
Last Updated: | July 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00727285 |
Health Authority: | United States: Institutional Review Board |
Cystic Fibrosis pulmonary exacerbation gene expression |
biomarker inflammation CF pulmonary exacerbation |
Digestive System Diseases Genetic Diseases, Inborn Respiratory Tract Diseases Cystic Fibrosis Fibrosis |
Lung Diseases Infant, Newborn, Diseases Pancreatic Diseases Cystic fibrosis Inflammation |
Pathologic Processes |