NCT05193552 · University of Alabama at Birmingham
Usage of Spirometry in Managing IgG Therapy in CVID With Airway Disease
What this study 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.
View original scientific description
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.
Interventions
DRUG
Hizentra
subjects level of immunoglobulin replacement therapy will be adjusted for bioavailability as per manufacturer's instructions
Primary outcome measures
FEV1 at baseline
Time frame: baseline
Pulmonary function will be measured by forced expiratory volume in one second (FEV1) at baseline.
FEV1 at 3 months
Time frame: 3 months
Pulmonary function will be measured by forced expiratory volume in one second (FEV1) at three months into the study.
FEV1 at 6 months.
Time frame: 6 months
Pulmonary function will be measured by forced expiratory volume in one second (FEV1) at six months into the study.
FVC at baseline
Time frame: baseline
Pulmonary function will be measured by forced vital capacity (FVC) at baseline.
FVC at 3 months
Time frame: 3 months
Pulmonary function will be measured by forced vital capacity (FVC) at three months.
FVC at 6 months.
Time frame: 6 months
Pulmonary function will be measured by forced vital capacity (FVC) at six months.
FEF25-75% at baseline
Time frame: baseline
Pulmonary function will be measured by forced expiratory flow at 25 and 75% of the pulmonary volume (FEF25-75%) at baseline.
FEF25-75% at 3 months
Time frame: 3 months
Pulmonary function will be measured by forced expiratory flow at 25 and 75% of the pulmonary volume (FEF25-75%) at 3 months.
FEF25-75% at 6 months
Time frame: 6 months
Pulmonary function will be measured by forced expiratory flow at 25 and 75% of the pulmonary volume (FEF25-75%) at six months.
FEV1/FVC ratio at baseline
Time frame: 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.
FEV1/FVC ratio at 3 months
Time frame: 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.
FEV1/FVC ratio at 6 months
Time frame: 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.
FOT at baseline.
Time frame: baseline
Forced Oscillation Technique (FOT) will be measured at baseline. Forced Oscillation Technique (FOT) measures lung impedance during tidal breathing.
FOT at 3 months.
Time frame: 3 months
Forced Oscillation Technique (FOT) will be measured at 3 months. Forced Oscillation Technique (FOT) measures lung impedance during tidal breathing.
FOT at 6 months.
Time frame: 6 months
Forced Oscillation Technique (FOT) will be measured at 6 months. Forced Oscillation Technique (FOT) measures lung impedance during tidal breathing.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Where
- Birmingham, Alabama
Collaborators
CSL Behring
Related conditions & keywords
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Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
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Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
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Data: ClinicalTrials.gov · synced May 4, 2026 · Source of record for eligibility and locations