Status:
RECRUITING
Usage of Spirometry in Managing IgG Therapy in CVID with Airway Disease
Lead Sponsor:
University of Alabama at Birmingham
Conditions:
Common Variable Immunodeficiency
Eligibility:
All Genders
21+ years
Phase:
PHASE4
Brief Summary
Although there is evidence in the literature that gammaglobulin replacement therapy can lead to a reduction in the prevalence of pulmonary infection and improved lung function, there is no published s...
Detailed Description
The key finding of the published retrospective study was that common variable immune deficiency (CVID) patients with moderate, presumed reversible, obstruction on stable, therapeutic doses of IgG who ...
Eligibility Criteria
Inclusion
- 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.
- Patients who are already on Hizentra will be preferred.
Exclusion
- Age \<21 or cannot perform spirometry.
- 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.
- 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.
- Patients with heart failure, TB, bronchiolitis, or lymphangioleiomyomatosis.
Key Trial Info
Start Date :
January 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT05193552
Start Date
January 15 2024
End Date
December 1 2027
Last Update
March 11 2025
Active Locations (1)
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1
Community Health 20
Birmingham, Alabama, United States, 35205