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NCT05193552 · ClinicalTrials.gov registry record · Phase 4
Usage of Spirometry in Managing IgG Therapy in CVID with Airway Disease
A Phase 4 study of Common Variable Immunodeficiency, sponsored by University of Alabama at Birmingham.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 22
- Enrollment target
- 1
- Study location
NCT05193552: Recruiting Phase 4 study of Common Variable Immunodeficiency, sponsored by University of Alabama at Birmingham.
NCT05193552 is a Phase 4 study of Common Variable Immunodeficiency that is actively recruiting participants, run by University of Alabama at Birmingham. The registered enrollment target is 22 participants, below the 227-participant average among 7 other Common Variable Immunodeficiency trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05193552, a Phase 4 study of Common Variable Immunodeficiency, is actively recruiting participants, sponsored by University of Alabama at Birmingham.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 22 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Pulmonary function will be measured by forced expiratory volume in one second (FEV1) at baseline.
Conditions Studied
Interventions
- DRUG Hizentra
Study Locations (1)
Alabama
- Community Health 20 - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2024-01-15 |
| Est. Completion | 2027-12 |
| Phase | Phase 4 |
What NCT05193552 shows while recruiting
NCT05193552 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 227-participant average among 7 other Common Variable Immunodeficiency trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Common Variable Immunodeficiency appearing as the primary indexed condition, and to 1 intervention - of which Hizentra is the first listed.
NCT05193552 reports a single indexed study location in Alabama.
Frequently Asked Questions
What is clinical trial NCT05193552 about?
NCT05193552 is a clinical study titled "Usage of Spirometry in Managing IgG Therapy in CVID with Airway Disease". 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...
What is the current status of trial NCT05193552?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 22 participants. The study started on 2024-01-15. Estimated completion is 2027-12.
What conditions does trial NCT05193552 study?
This clinical trial studies the following conditions: Common Variable Immunodeficiency.
What interventions are being tested in trial NCT05193552?
The interventions under investigation include: Hizentra (DRUG).
Who is sponsoring clinical trial NCT05193552?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05193552 being conducted?
This trial has 1 study location across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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