Investigating how lung diseases affect white blood cells in the lungs
The Role of Conformational Diseases on Macrophage Function
This study is trying to see how Alpha-1-antitrypsin deficiency and Cystic Fibrosis affect important white blood cells in the lungs, which could help us understand lung inflammation and disease better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 220 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Florida Academic / other |
| Locations | 1 site (Gainesville, Florida) |
| Trial ID | NCT01851642 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the impact of Alpha-1-antitrypsin deficiency and Cystic Fibrosis on the functionality of lung macrophages, which are crucial white blood cells involved in inflammation and tissue repair. The study will involve participants undergoing a history and physical examination, blood draws, pulmonary function testing, and the use of an albuterol inhaler. By understanding how these conditions impair macrophage function, the research seeks to uncover new insights into the mechanisms behind lung inflammation and disease progression.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a diagnosis of Alpha-1-antitrypsin deficiency or Cystic Fibrosis.
Not a fit: Patients who are pregnant, breastfeeding, or have significant medical conditions that could affect their safety may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of lung diseases associated with AAT deficiency and Cystic Fibrosis.
How similar studies have performed: While the specific approach of this study is novel, previous research has indicated that understanding macrophage function in lung diseases can lead to significant insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Signed informed consent * Male or female 18 years of age or older * Negative pregnancy test for women of childbearing potential * Hemoglobin \>12.5 g/dl measured on the day of participation * Negative urine nicotine test Exclusion Criteria: * Pregnancy or breastfeeding * Weight \< 50 kg * History of anemia requiring blood transfusions, erythropoietin supplementation, or iron supplementation within the past 36 months * Known hemoglobin \<12.5 g/dl within the past 90 days * Systolic blood pressure \> 180 mmHg and/or diastolic blood pressure \>100 mmHg * Poor venous access * Large volume blood donation (\>200 ml or 7 ounces) within the previous 56 days (e.g. blood donation for the purposes of blood banking) * Clinically significant cardiac, hemostatic or neurological impairment or any other significant medical condition that, in the opinion of the investigator would affect subject safety (e.g., recent myocardial infarction, history of prolonged bleeding time, cerebral vascular accident, advanced cancer or uncontrolled medical condition) * Psychiatric or cognitive disturbance or illness that would affect subject safety * Current smoker
Where this trial is running
Gainesville, Florida
- Shands at the University of Florida — Gainesville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Karina Serban, MD — University of Florida, College of Medicine, Division of Pulmonary, Critical Care, and Sleep Medicine
- Study coordinator: Allison E. Faunce, B.A.
- Email: Allison.Faunce@medicine.ufl.edu
- Phone: 352-273-8666
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.