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

Last updated: March 6, 2025
Sponsor: University of Alabama at Birmingham
Overall Status: Active - Recruiting

Phase

4

Condition

Hypogammaglobulinemia

Treatment

Hizentra

Clinical Study ID

NCT05193552
I300005696
  • Ages > 21
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Inclusion Criteria:

  1. Patients who meet criteria for common variable immune deficiency (CVID) who are onstable IGRT for at least 3 months and who have an FEF25-75% between 50% and 80% ofpredicted.

  2. Patients who are already on Hizentra will be preferred.

Exclusion

Exclusion Criteria:

  1. Age <21 or cannot perform spirometry.

  2. Smokers with 20 pack years or more, and active smokers will not be included amongthe study subjects, but will be considered separately as an ancillary study.

  3. Patients with specific antigen-specific antibody deficiencies or X-linkedagammaglobulinemia on IGRT will not be included among the 20 study subjects, butwill be considered separately in ancillary studies.

  4. Patients with heart failure, TB, bronchiolitis, or lymphangioleiomyomatosis.

Study Design

Total Participants: 22
Treatment Group(s): 1
Primary Treatment: Hizentra
Phase: 4
Study Start date:
January 15, 2024
Estimated Completion Date:
December 31, 2027

Study Description

The key finding of the published retrospective study was that common variable immune deficiency (CVID) patients with moderate, presumed reversible, obstruction on stable, therapeutic doses of IgG who exhibited a decline in lung function from one clinic visit to the next responded to an increased dose of IgG with an improvement in lung function as assessed by spirometry.

The investigators now wish perform a clinical trial to assess whether primary antibody deficiency patients receiving IGRT who fit in this range of obstruction, i.e. an FEF25-75% that is 50-80% of predicted, will demonstrate an increase in lung function, as assessed by spirometry, after increasing the dose of IGRT. The presumption is that obstruction at this level is most likely due to the effects of subclinical infections that can be reduced or avoided by increasing the amount of gammaglobulin received by the patients.

Connect with a study center

  • Community Health 20

    Birmingham, Alabama 35205
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.