Nasal Epithelial Cells/Blood Lymphocyte Markers for Cystic Fibrosis (CF)/CF Pulmonary Exacerbations
Completed
Conditions studied: Cystic Fibrosis
In brief
Study Hypothesis: We hypothesize that cellular markers from nasal epithelial cells and blood lymphocytes can serve as potential biomarkers reflect the underlying inflammatory state of the lung and will be helpful in determining the presence of a CF pulmonary exacerbation and its overall severity.
Key facts
- Study ID
- NCT00381628
- Run by
- University Hospitals Cleveland Medical Center
- People needed
- 59
- Starts
- 2006-09-01
- Expected to finish
- 2011-09-01
- Last updated by the study team
- 2019-02-15
Who can join
Age: 15 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Male or female >= 15 years of age
- Confirmed diagnosis of CF
- Clinically stable with no evidence of acute upper respiratory tract infection or current pulmonary exacerbation within the previous month
- Ability to understand and sign a written informed consent and comply with the requirements of the study
You may not qualify if…
- Chronic use of a medication with anti-neutrophil or anti-inflammatory effect (ibuprofen, systemic or inhaled corticosteroids, or other immunosuppressive agents, etc
- Oxygen saturation <92% on room air
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the subject or the quality of the data
- CF patients with pulmonary exacerbations:
- Male of female >= 15 years of age Confirmed diagnosis of CF
- Patient meets a modified definition for a pulmonary exacerbation based upon Fuchs criteria which is treated with intravenous antibiotics for any 4 of the following 12 signs or symptoms:
- Increased sputum production
- New or increased coughing up of blood
- Increased cough
- Increased dyspnea with exertion
- Malaise, fatigue or lethargy
- Anorexia or weight loss
- Fever
- Sinus pain or tenderness
- Changes in sinus discharge
- New findings on chest examination
- Decline in forced expiratory volume in 1 second (FEV1) > 10% since previous visit
- Radiographic changes indicative of pulmonary infection
- Ability to understand and sign a written informed consent and comply with the requirements of the study
- Exclusion criteria for CF patients with pulmonary exacerbation:
- Concurrent use a medication with anti-neutrophil or anti-inflammatory effect within the previous 4 weeks
- Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the subject or the quality of the data.
- Inclusion Criteria - Asthma patients
- Male or female >= 15 years of age
- Physician diagnosed asthma
Where it is running
- Rainbow Babies and Children's Hospital — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
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