N/A
N=59
Nasal Epithelial Cells/Blood Lymphocyte Markers for Cystic Fibrosis (CF)/CF Pulmonary Exacerbations
Cystic Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT00381628 ↗Enrolled (actual)
59
Serious AEs
0.0%
Results posted
Feb 2017
Primary outcome: Primary: The Number of Participants With Blood and Sputum Samples Collected — 18; 27; 0; 14 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- epithelial cells and blood lymphocyte extraction (Procedure)
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- All
- Sponsor
- University Hospitals Cleveland Medical Center
- Primary completion
- Sep 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Participants With Blood and Sputum Samples Collected |
18; 27; 0; 14 | — |
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 will be helpful in determining the presence of a CF pulmonary exacerbation and its overall severity.
Eligibility Criteria
Stable CF Patients:
Inclusion Criteria
- 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 Criteria
- Chronic use of a medication with anti-neutrophil or anti-inflammatory effect (ibuprofen, systemic or inhaled corticosteroids, or other immunosuppressive agents, etc
- Oxygen saturation = 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 = 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
Data sourced from ClinicalTrials.gov (NCT00381628). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.