Nasal Epithelial Cells/Blood Lymphocyte Markers for Cystic Fibrosis (CF)/CF Pulmonary Exacerbations

NCT00381628 | Completed Results

• 1 other identifier: Protocol 08-06-23
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 1

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 will be helpful in determining the presence of a CF pulmonary exacerbation and its overall severity.

Conditions

Cystic Fibrosis

Keywords

Anatomy; cells; epithelial cells; blood cells; cystic fibrosis; equipment and supplies; disposable equipment; reagent kits

Outcome Measures

Primary Outcomes (1)

• The Number of Participants With Blood and Sputum Samples Collected

  Blood and sputum samples for general science research collaborators

  Baseline

Study Arms (4)

Stable subjects with CF

These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro.

Procedure: epithelial cells and blood lymphocyte extraction

Exacerbating subjects with CF

These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) at the beginning and end of treatment for a pulmonary exacerbation. These cells will be studied in vitro.

Procedure: epithelial cells and blood lymphocyte extraction

Stable subjects with asthma

These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro. This is the disease control group.

Procedure: epithelial cells and blood lymphocyte extraction

Healthy volunteers

These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro. This is the control group

Procedure: epithelial cells and blood lymphocyte extraction

Interventions

epithelial cells and blood lymphocyte extraction PROCEDURE

Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated.

Exacerbating subjects with CF; Healthy volunteers; Stable subjects with CF; Stable subjects with asthma

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Nasal epithelial cells and blood will be obtained from four groups of subjects age 15 years and older: Stable subjects with CF at baseline, Subjects with CF at the beginning and end of treatment for a pulmonary exacerbation, stable subjects with asthma, and healthy voulnteers

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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• Cystic Fibrosis Foundation: collaborator

Study Sites (1)

Rainbow Babies and Children's Hospital

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Results Point of Contact

• Title: Dr. James Chmiel
• Organization: Riley Hospital for Children

jfchmiel@iu.edu

317-948-7180

Study Officials

• James F Chmiel, MD, MPH

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: September 27, 2006
• First Posted: September 28, 2006
• Study Start: September 1, 2006
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: February 15, 2019
• Results First Posted: February 15, 2017

Record last verified: 2019-01

Locations

US (1)