A Prospective Study of the Utility of Spirometry to Identify and Manage Immunoglobulin Replacement Dosage in Primary Antibody Deficiency in Patients with Potentially Reversible Airway Disease

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 21
Healthy Volunteers: t
View:

• 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.

Locations
United States
Alabama
Community Health 20
RECRUITING
Birmingham
Contact Information
Primary
Leigh Powell
lcpowell@uabmc.edu
2053319159
Backup
Tracy Hwangpo, MD/PhD
thwangpo@uabmc.edu
2059960161
Time Frame
Start Date: 2024-01-15
Estimated Completion Date: 2027-12
Participants
Target number of participants: 22
Treatments
No_intervention: Control Group
11 subjects will be treated for 6 months at their current dose of Hizentra
Experimental: Treatment Group
11 subjects will have their level of immunoglobulin replacement therapy 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.
Related Therapeutic Areas
Sponsors
Leads: University of Alabama at Birmingham

This content was sourced from clinicaltrials.gov