Actively Recruiting

Phase 4
Age: 21Years +
All Genders
Healthy Volunteers
NCT05193552

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

Age: 21Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Community Health 20

Birmingham, Alabama, United States, 35205

Actively Recruiting

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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

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