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Breathing test could help doctors personalize antibody therapy for immune deficiency

NCT ID NCT05193552

Disease control Sponsor: University of Alabama at Birmingham Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether a simple breathing test (spirometry) can help doctors decide the right dose of immunoglobulin therapy for people with common variable immune deficiency (CVID). Researchers will enroll 22 adults with CVID who already take a stable dose of Hizentra. Half will stay on their current dose, while the other half will get a slightly higher dose for 6 months. The goal is to see if the higher dose improves lung function and reduces fatigue.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Hizentra (subcutaneous immunoglobulin)
What this could lead to
If successful, this could give doctors a simple way to fine-tune immunoglobulin doses for people with CVID, potentially improving lung health and quality of life.
What could go wrong
This is a very small early-phase study with only 22 participants, so results may not apply to everyone. It is testing a dosing strategy, not a new drug, so the impact is likely modest.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 22 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2024

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

common variable immunodeficiency

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Common variable immunodeficiency

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Community Health 20

    RECRUITING

    Birmingham, Alabama, 35205, United States

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