Usage of Spirometry in Managing IgG Therapy in CVID with Airway Disease

Launched by UNIVERSITY OF ALABAMA AT BIRMINGHAM · Dec 27, 2021

Keywords

ClinConnect Summary

This clinical trial is studying how spirometry, a simple breathing test, can help doctors decide if patients with Common Variable Immunodeficiency (CVID) and breathing issues might benefit from a higher dose of immunoglobulin replacement therapy (IGRT). The researchers want to see if increasing the dose can improve lung function and reduce the risk of lung infections. They will enroll 22 participants who have been on a stable dose of IGRT and have mild to moderate breathing obstruction. Half of the participants will continue with their current dose, while the other half will receive a slightly higher dose over six months.

To be eligible for the trial, participants need to be adults aged 21 or older with diagnosed CVID, and they must have been on a stable IGRT regimen for at least three months. Participants should also be able to complete the spirometry test. Patients who smoke heavily or have certain health conditions, like heart failure or specific types of lung disease, will not be included in this study. Participants can expect regular check-ups and monitoring during the trial, and the goal is to determine if adjusting their IGRT dosage can lead to better health outcomes.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients who meet criteria for common variable immune deficiency (CVID) who are on stable IGRT for at least 3 months and who have an FEF25-75% between 50% and 80% of predicted.
• • 2. Patients who are already on Hizentra will be preferred.
• Exclusion Criteria:
• • 1. Age \<21 or cannot perform spirometry.
• • 2. Smokers with 20 pack years or more, and active smokers will not be included among the study subjects, but will be considered separately as an ancillary study.
• • 3. Patients with specific antigen-specific antibody deficiencies or X-linked agammaglobulinemia on IGRT will not be included among the 20 study subjects, but will be considered separately in ancillary studies.
• • 4. Patients with heart failure, TB, bronchiolitis, or lymphangioleiomyomatosis.