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

Recruiting now · Phase 4

Conditions studied: Common Variable Immunodeficiency

In brief

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.

Key facts

Study ID

NCT05193552

Run by

University of Alabama at Birmingham

People needed

22

Starts

2024-01-15

Expected to finish

2027-12-01

Last updated by the study team

2026-05-04

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Community Health 20 — Birmingham, Alabama, United States (enrolling)

Full record on ClinicalTrials.gov

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