NCT05193552 Usage of Spirometry in Managing IgG Therapy in CVID With Airway Disease
| NCT ID | NCT05193552 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Alabama at Birmingham |
| Condition | Common Variable Immunodeficiency |
| Study Type | INTERVENTIONAL |
| Enrollment | 22 participants |
| Start Date | 2024-01-15 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 22 participants in total. It began in 2024-01-15 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 study to guide immunologists regarding the use of spirometry in titrating IG therapy to assist in the management of immunodeficiency patients with regards to gammaglobulin replacement therapy. The investigators propose to study the use of spirometry to identify patients that could potentially benefit from an increase in IGRT. The investigators will identify 22 common variable immune deficiency (CVID) study subjects on stable IGRT replacement therapy equivalent to 0.40 to 0.60 gm/kg per 4 weeks who have evidence of mild to moderate obstruction as assessed by an FEF25-75% between 50% and 80% of predicted. Patients who are on Hizentra will be preferentially recruited. Of these 22, 11 will be identified at random and treated for 6 months at their current dose (control population). The remaining 11 study subjects (treatment group) will have their level of IGRT increased by the equivalent of 0.05 gm/kg in dose per 4 weeks, adjusted for bioavailability as per manufacturer's instructions. On average, rounded up to the nearest gram, this will typically increase their dose of Hizentra by 2 gm per week.
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.
Contact & Investigator
Harry Schroeder, MD/PhD
PRINCIPAL INVESTIGATOR
University of Alabama at Birmingham
Frequently Asked Questions
Who can join the NCT05193552 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Common Variable Immunodeficiency. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05193552 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05193552 currently recruiting?
Yes, NCT05193552 is actively recruiting participants. Contact the research team at lcpowell@uabmc.edu for enrollment information.
Where is the NCT05193552 trial being conducted?
This trial is being conducted at Birmingham, United States.
Who is sponsoring the NCT05193552 clinical trial?
NCT05193552 is sponsored by University of Alabama at Birmingham. The principal investigator is Harry Schroeder, MD/PhD at University of Alabama at Birmingham. The trial plans to enroll 22 participants.