Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Influencing Progression of Airway Disease in Primary Antibody Deficiency

This study is investigating if giving a higher dose of immunoglobulin (Ig) replacement therapy can help people with certain primary antibody deficiencies (conditions where your body doesn't make enough protective antibodies). Specifically, it aims to see if this higher dose can slow down or prevent lung damage and breathing problems, which are common in these conditions. We will compare changes in lung health, measured by special scans and other health checks, over a two-year period between patients receiving the usual Ig dose and those getting a higher dose. The goal is to find better ways to protect the lungs and improve the quality of life for people living with these conditions.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Universitair Medisch Centrum Utrecht

Enrolment target

100

Start

12 Jul 2024

What is this study about?

This important study is designed for people who have primary antibody deficiency. This is a group of conditions where your immune system doesn't make enough antibodies, which are like the body's soldiers fighting off infections. This can lead to more frequent and severe infections, especially in the lungs, which can cause long-term breathing problems.

The main aim of this research is to see if giving a slightly higher dose of your usual immunoglobulin (Ig) replacement therapy can help protect your lungs more effectively. Immunoglobulin therapy provides the missing antibodies to help your body fight off infections. We want to find out if increasing the amount you receive can better prevent or slow down the lung damage that can happen in these conditions.

To do this, we'll carefully measure changes in your lung health over two years, mainly using special scans called CT scans. We'll compare people who continue with their standard Ig dose to those who receive a higher dose, to see if there's a difference in how their lungs change. We'll also look at things like how often you get infections, your quality of life, and any time you might miss from school or work due to illness.

Key takeaways

Aims to improve lung health for people with primary antibody deficiency.
Compares standard vs. higher doses of Ig therapy over two years.
Uses CT scans and other measures to track lung changes.
Includes tracking infections, quality of life, and treatment costs.
Participation is for adults aged 18 and over with specific antibody deficiencies.

Who may be eligible?

This study is looking for adults aged 18 years and older. Both men and women can take part.

You might be able to join if you have been diagnosed with one of several primary antibody deficiency conditions. These include things like unclassified antibody deficiency (unPAD), IgA deficiency, specific polysaccharide antibody deficiency (SPAD), IgG subclass deficiency (IgSD), common variable immunodeficiency (CVID), or agammaglobulinemia (including X-linked agammaglobulinemia).

If you have one of these conditions and are an adult, you could potentially be a good fit for this research.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a diagnosis of primary antibody deficiency (e.g., CVID, unPAD, IgSD)?
Are you currently receiving immunoglobulin replacement therapy?
Are you able to attend regular hospital appointments?

Answer every question to see your result.

What does participation involve?

If you join this study, you would receive your immunoglobulin (Ig) replacement therapy, either at your standard dose or a slightly higher dose, for two years. Your treatment will be one of several commonly used Ig products. Throughout the study, you'll have regular hospital visits, similar to your usual appointments, for tests and check-ups.

Key assessments will include CT scans of your lungs at the beginning of the study and again after two years to measure any changes. You'll also be asked to keep a daily diary for two separate two-month periods to record any lung symptoms. We will track how often you get respiratory infections, and you'll complete questionnaires about your quality of life and any time missed from school or work due to infections. Your Ig levels will be monitored, and all costs related to your healthcare during the study will be recorded. The total duration of active participation for the main assessment is two years.

Potential risks and benefits

Taking part in this study might offer the benefit of potentially better lung protection if the higher Ig dose proves more effective. You would also receive very close monitoring of your health and lung condition. However, as with any medical study, there are potential risks, such as side effects from the medication, though we are using commonly prescribed treatments. We will carefully watch for any side effects or unexpected reactions. Your participation is completely voluntary, and you have the right to withdraw from the study at any time without explaining why, and this will not affect your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Netherlands

Common questions

What is primary antibody deficiency?

It's a condition where your body doesn't produce enough antibodies, making you more prone to infections, especially in the lungs.

What is immunoglobulin (Ig) replacement therapy?

It's a treatment that provides your body with the antibodies it's missing, helping your immune system fight off infections.

Will I know if I'm getting a higher dose or the standard dose?

This study is 'blinded', meaning neither you nor your doctor will know if you're receiving the standard or higher dose until the study ends. This helps ensure fair results.

What kind of scans will I have?

You will have CT scans of your lungs (at the start and end of the study) to get detailed images and help us see if there are any changes.

How long will I be in the study?

Your active participation in the study, involving treatment and assessments, would last for two years.