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

NCT05193552 | Recruiting Phase 4 DMC FDA Drug

• 2 other identifiers: I3000056962024805
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Common Variable Immunodeficiency

Outcome Measures

Primary Outcomes (15)

• FEV1 at baseline

  Pulmonary function will be measured by forced expiratory volume in one second (FEV1) at baseline.

  baseline

• FEV1 at 3 months

  Pulmonary function will be measured by forced expiratory volume in one second (FEV1) at three months into the study.

  3 months

• FEV1 at 6 months.

  Pulmonary function will be measured by forced expiratory volume in one second (FEV1) at six months into the study.

  6 months

• FVC at baseline

  Pulmonary function will be measured by forced vital capacity (FVC) at baseline.

  baseline

• FVC at 3 months

  Pulmonary function will be measured by forced vital capacity (FVC) at three months.

  3 months

• FVC at 6 months.

  Pulmonary function will be measured by forced vital capacity (FVC) at six months.

  6 months

• FEF25-75% at baseline

  Pulmonary function will be measured by forced expiratory flow at 25 and 75% of the pulmonary volume (FEF25-75%) at baseline.

  baseline

• FEF25-75% at 3 months

  Pulmonary function will be measured by forced expiratory flow at 25 and 75% of the pulmonary volume (FEF25-75%) at 3 months.

  3 months

• FEF25-75% at 6 months

  Pulmonary function will be measured by forced expiratory flow at 25 and 75% of the pulmonary volume (FEF25-75%) at six months.

  6 months

• FEV1/FVC ratio at baseline

  FEV1/FVC ratio will be calculated at baseline. The FEV1/FVC ratio is the ratio of the forced expiratory volume in the first one second (FEV1) to the forced vital capacity (FVC) of the lungs.

  baseline

• FEV1/FVC ratio at 3 months

  FEV1/FVC ratio will be calculated at 3 months. The FEV1/FVC ratio is the ratio of the forced expiratory volume in the first one second (FEV1) to the forced vital capacity (FVC) of the lungs.

  3 months

• FEV1/FVC ratio at 6 months

  FEV1/FVC ratio will be calculated at 6 months. The FEV1/FVC ratio is the ratio of the forced expiratory volume in the first one second (FEV1) to the forced vital capacity (FVC) of the lungs.

  6 months

• FOT at baseline.

  Forced Oscillation Technique (FOT) will be measured at baseline. Forced Oscillation Technique (FOT) measures lung impedance during tidal breathing.

  baseline

• FOT at 3 months.

  Forced Oscillation Technique (FOT) will be measured at 3 months. Forced Oscillation Technique (FOT) measures lung impedance during tidal breathing.

  3 months

• FOT at 6 months.

  Forced Oscillation Technique (FOT) will be measured at 6 months. Forced Oscillation Technique (FOT) measures lung impedance during tidal breathing.

  6 months

Secondary Outcomes (3)

• FACIT score at baseline and monthly on therapy

  6 months

• PADQOL-16 at baseline and monthly on therapy

  6 months

• St. George's Respiratory Questionnaire at baseline and monthly on therapy

  6 months

Study Arms (2)

Control Group

NO INTERVENTION

11 subjects will be treated for 6 months at their current dose of Hizentra

Treatment Group

EXPERIMENTAL

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.

Drug: Hizentra

Interventions

Hizentra DRUG

subjects level of immunoglobulin replacement therapy will be adjusted for bioavailability as per manufacturer's instructions

Also known as: subcutaneous gammaglobulin therapy

Treatment Group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• CSL Behring: collaborator
• University of Alabama at Birmingham: lead

Study Sites (1)

Community Health 20

Birmingham, Alabama, 35205, United States

RECRUITING

MeSH Terms

Conditions

Common Variable Immunodeficiency

Interventions

Hizentra

Condition Hierarchy (Ancestors)

Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Harry Schroeder, MD/PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leigh Powell

CONTACT

2053319159; lcpowell@uabmc.edu

Tracy Hwangpo, MD/PhD

CONTACT

2059960161; thwangpo@uabmc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 6, 2021
• First Posted: January 18, 2022
• Study Start: January 15, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)