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.
Age range
21 Years
Sex
ALL
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Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
FEV1 at baseline
Timeframe: baseline
FEV1 at 3 months
Timeframe: 3 months
FEV1 at 6 months.
Timeframe: 6 months
FVC at baseline
Timeframe: baseline
FVC at 3 months
Timeframe: 3 months
FVC at 6 months.
Timeframe: 6 months
FEF25-75% at baseline
Timeframe: baseline
FEF25-75% at 3 months
Timeframe: 3 months
FEF25-75% at 6 months
Timeframe: 6 months
FEV1/FVC ratio at baseline
Timeframe: baseline
FEV1/FVC ratio at 3 months
Timeframe: 3 months
FEV1/FVC ratio at 6 months
Timeframe: 6 months
FOT at baseline.
Timeframe: baseline
FOT at 3 months.
Timeframe: 3 months
FOT at 6 months.
Timeframe: 6 months