Status:
COMPLETED
Nasal Epithelial Cells/Blood Lymphocyte Markers for Cystic Fibrosis (CF)/CF Pulmonary Exacerbations
Lead Sponsor:
University Hospitals Cleveland Medical Center
Collaborating Sponsors:
Cystic Fibrosis Foundation
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
15+ years
Brief Summary
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 wil...
Detailed Description
Cystic fibrosis (CF) is the most common lethal genetic disease in the US afflicting approximately 30,000 people. Chronic disease of the respiratory tract, which is responsible for early death, affects...
Eligibility Criteria
Inclusion
- Stable CF Patients:
- 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
Exclusion
- 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
- Clinically stable with no evidence of acute upper or lower respiratory tract infection or current pulmonary exacerbation within the previous month
- Exclusion Criteria - Asthma patients
- Chronic use of a medication with anti-neutrophil or anti-inflammatory effect within the previous 4 weeks
- Treated for an asthma exacerbation with the previous 4 weeks
- Treated with oral corticosteroids within the previous 4 weeks
- 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.
- Inclusion Criteria for Healthy Volunteers
- Male or female \>= 18 years of age
- Free of any chronic medical condition
- Clinically stable with no evidence of acute upper or lower respiratory tract infection within the previous month
- Ability to understand and sign a written informed consent and comply with the requirements of the study
- Exclusion Criteria for Healthy Volunteers
- Use of a medication with anti-neutrophil or anti-inflammatory effect within the previous 4 months
- Presence of any chronic medical condition
- 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
Key Trial Info
Start Date :
September 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT00381628
Start Date
September 1 2006
End Date
September 1 2011
Last Update
February 15 2019
Active Locations (1)
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1
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States, 44106