Actively Recruiting
Usage of Spirometry in Managing IgG Therapy in CVID With Airway Disease
Led by University of Alabama at Birmingham · Updated on 2026-05-04
22
Participants Needed
1
Research Sites
202 weeks
Total Duration
On this page
Sponsors
U
University of Alabama at Birmingham
Lead Sponsor
C
CSL Behring
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Usage of Spirometry in Managing IgG Therapy in CVID With Airway Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with common variable immune deficiency (CVID) who have been on stable immunoglobulin replacement therapy (IGRT) for at least 3 months
- Have an FEF25-75% between 50% and 80% of predicted indicating mild to moderate airway obstruction
- Patients already receiving Hizentra will be preferred
You will not qualify if you...
- Younger than 21 years old or unable to perform spirometry
- Smokers with 20 or more pack years or active smokers
- Patients with specific antigen-specific antibody deficiencies or X-linked agammaglobulinemia on IGRT
- Patients with heart failure, tuberculosis, bronchiolitis, or lymphangioleiomyomatosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Community Health 20
Birmingham, Alabama, United States, 35205
Actively Recruiting
Research Team
L
Leigh Powell
CONTACT
T
Tracy Hwangpo, MD/PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here