About this trial
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
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Hizentra
Drugsubjects level of immunoglobulin replacement therapy will be adjusted for bioavailability as per manufacturer's instructions
Treatment groups
Trial outcomes
Primary outcomes
FEV1 at baseline
Pulmonary function will be measured by forced expiratory volume in one second (FEV1) at baseline.
FEV1 at 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.
Pulmonary function will be measured by forced expiratory volume in one second (FEV1) at six months into the study.
FVC at baseline
Pulmonary function will be measured by forced vital capacity (FVC) at baseline.
Secondary outcomes
FACIT score at baseline and monthly on therapy
assess the effect of increasing the dose of IGRT on the patients' well-being by quantitating their fatigue level. Scores range from zero (no fatigue) to 52 (maximum fatigue/worse outcome).
PADQOL-16 at baseline and monthly on therapy
assess the effect of increasing the dose of IGRT on the patients' well-being by quantitating their quality of life. Scores range from zero (no impairment) to 32 (maximum impairment/worse outcome).
St. George's Respiratory Questionnaire at baseline and monthly on therapy
Disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Scores range from zero (no impairment) to 100 (maximum impairment/worse outcome).
Sponsors and contacts
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University of Alabama at Birmingham
Lead sponsor
CSL Behring
Collaborator