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NCT Number: NCT05193552

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 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.

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Key information

Conditions

Common Variable Immunodeficiency Immune System Diseases Immunologic Deficiency Syndromes

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

About this study

The key finding of the published retrospective study was that common variable immune deficiency (CVID) patients with moderate, presumed reversible, obstruction on stable, therapeutic doses of IgG who exhibited a decline in lung function from one clinic visit to the next responded to an increased dose of IgG with an improvement in lung function as assessed by spirometry.

The investigators now wish perform a clinical trial to assess whether primary antibody deficiency patients receiving IGRT who fit in this range of obstruction, i.e. an FEF25-75% that is 50-80% of predicted, will demonstrate an increase in lung function, as assessed by spirometry, after increasing the dose of IGRT. The presumption is that obstruction at this level is most likely due to the effects of subclinical infections that can be reduced or avoided by increasing the amount of gammaglobulin received by the patients.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Patients who are already on Hizentra will be preferred.

Exclusion criteria

  • Age <21 or cannot perform spirometry.
  • 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.
  • 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.
  • Patients with heart failure, TB, bronchiolitis, or lymphangioleiomyomatosis.

Treatment and study plan

Hizentra

Drug

subjects level of immunoglobulin replacement therapy will be adjusted for bioavailability as per manufacturer's instructions

Other names: subcutaneous gammaglobulin therapy

Primary outcomes

  1. FEV1 at baseline

    Time frame: baseline

    Pulmonary function will be measured by forced expiratory volume in one second (FEV1) at baseline.

  2. FEV1 at 3 months

    Time frame: 3 months

    Pulmonary function will be measured by forced expiratory volume in one second (FEV1) at three months into the study.

  3. FEV1 at 6 months.

    Time frame: 6 months

    Pulmonary function will be measured by forced expiratory volume in one second (FEV1) at six months into the study.

  4. FVC at baseline

    Time frame: baseline

    Pulmonary function will be measured by forced vital capacity (FVC) at baseline.

  5. FVC at 3 months

    Time frame: 3 months

    Pulmonary function will be measured by forced vital capacity (FVC) at three months.

  6. FVC at 6 months.

    Time frame: 6 months

    Pulmonary function will be measured by forced vital capacity (FVC) at six months.

  7. FEF25-75% at baseline

    Time frame: baseline

    Pulmonary function will be measured by forced expiratory flow at 25 and 75% of the pulmonary volume (FEF25-75%) at baseline.

  8. FEF25-75% at 3 months

    Time frame: 3 months

    Pulmonary function will be measured by forced expiratory flow at 25 and 75% of the pulmonary volume (FEF25-75%) at 3 months.

  9. FEF25-75% at 6 months

    Time frame: 6 months

    Pulmonary function will be measured by forced expiratory flow at 25 and 75% of the pulmonary volume (FEF25-75%) at six months.

  10. FEV1/FVC ratio at baseline

    Time frame: baseline

    FEV1/FVC ratio will be calculated at baseline. The FEV1/FVC ratio is the ratio of the forced expiratory volume in the first one second (FEV1) to the forced vital capacity (FVC) of the lungs.

  11. FEV1/FVC ratio at 3 months

    Time frame: 3 months

    FEV1/FVC ratio will be calculated at 3 months. The FEV1/FVC ratio is the ratio of the forced expiratory volume in the first one second (FEV1) to the forced vital capacity (FVC) of the lungs.

  12. FEV1/FVC ratio at 6 months

    Time frame: 6 months

    FEV1/FVC ratio will be calculated at 6 months. The FEV1/FVC ratio is the ratio of the forced expiratory volume in the first one second (FEV1) to the forced vital capacity (FVC) of the lungs.

  13. FOT at baseline.

    Time frame: baseline

    Forced Oscillation Technique (FOT) will be measured at baseline. Forced Oscillation Technique (FOT) measures lung impedance during tidal breathing.

  14. FOT at 3 months.

    Time frame: 3 months

    Forced Oscillation Technique (FOT) will be measured at 3 months. Forced Oscillation Technique (FOT) measures lung impedance during tidal breathing.

  15. FOT at 6 months.

    Time frame: 6 months

    Forced Oscillation Technique (FOT) will be measured at 6 months. Forced Oscillation Technique (FOT) measures lung impedance during tidal breathing.

Secondary outcomes

  1. FACIT score at baseline and monthly on therapy

    Time frame: 6 months

    assess the effect of increasing the dose of IGRT on the patients' well-being by quantitating their fatigue level. Scores range from zero (no fatigue) to 52 (maximum fatigue/worse outcome).

  2. PADQOL-16 at baseline and monthly on therapy

    Time frame: 6 months

    assess the effect of increasing the dose of IGRT on the patients' well-being by quantitating their quality of life. Scores range from zero (no impairment) to 32 (maximum impairment/worse outcome).

  3. St. George's Respiratory Questionnaire at baseline and monthly on therapy

    Time frame: 6 months

    Disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Scores range from zero (no impairment) to 100 (maximum impairment/worse outcome).

Study contacts

Contact information is provided by the study sponsor or research team.

Leigh Powell

CONTACT

[email protected]

2053319159

Tracy Hwangpo, MD/PhD

CONTACT

[email protected]

2059960161

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • CSL Behring

Registry information

Official study title

A Prospective Study of the Utility of Spirometry to Identify and Manage Immunoglobulin Replacement Dosage in Primary Antibody Deficiency in Patients With Potentially Reversible Airway Disease

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jan 18, 2022
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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