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โ† Trials
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Usage of Spirometry in Managing IgG Therapy in CVID With Airway Disease

RecruitingPhase 4Ages 21 Years - anyAllUniversity of Alabama at Birmingham
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In plain words

What the trial is, and whether it could suit you

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 id

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. 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. 2. Patients who are already on Hizentra will be preferred. Exclusion Criteria: 1. Age \<21 or cannot perform spirometry. 2. 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. 3. 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. 4. Patients with heart failure, TB, bronchiolitis, or lymphangioleiomyomatosis.
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What it tests

  • Hizentra
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Where

1 site
Community Health 20
Birmingham, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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