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Usage of Spirometry in Managing IgG Therapy in CVID With Airway Disease

Primary Purpose

Common Variable Immunodeficiency

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Hizentra
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Common Variable Immunodeficiency

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Control Group

    Treatment Group

    Arm Description

    11 subjects will be treated for 6 months at their current dose of Hizentra

    11 subjects 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.

    Outcomes

    Primary Outcome Measures

    FEV1 at baseline
    Pulmonary function will be measured by forced expiratory volume in one second (FEV1) at baseline.
    FEV1 at 3 months
    Pulmonary function will be measured by forced expiratory volume in one second (FEV1) at three months into the study.
    FEV1 at 6 months.
    Pulmonary function will be measured by forced expiratory volume in one second (FEV1) at six months into the study.
    FVC at baseline
    Pulmonary function will be measured by forced vital capacity (FVC) at baseline.
    FVC at 3 months
    Pulmonary function will be measured by forced vital capacity (FVC) at three months.
    FVC at 6 months.
    Pulmonary function will be measured by forced vital capacity (FVC) at six months.
    FEF25-75% at baseline
    Pulmonary function will be measured by forced expiratory flow at 25 and 75% of the pulmonary volume (FEF25-75%) at baseline.
    FEF25-75% at 3 months
    Pulmonary function will be measured by forced expiratory flow at 25 and 75% of the pulmonary volume (FEF25-75%) at 3 months.
    FEF25-75% at 6 months
    Pulmonary function will be measured by forced expiratory flow at 25 and 75% of the pulmonary volume (FEF25-75%) at six months.
    FEV1/FVC ratio at 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.
    FEV1/FVC ratio at 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.
    FEV1/FVC ratio at 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.
    FOT at baseline.
    Forced Oscillation Technique (FOT) will be measured at baseline. Forced Oscillation Technique (FOT) measures lung impedance during tidal breathing.
    FOT at 3 months.
    Forced Oscillation Technique (FOT) will be measured at 3 months. Forced Oscillation Technique (FOT) measures lung impedance during tidal breathing.
    FOT at 6 months.
    Forced Oscillation Technique (FOT) will be measured at 6 months. Forced Oscillation Technique (FOT) measures lung impedance during tidal breathing.

    Secondary Outcome Measures

    FACIT score at baseline and monthly on therapy
    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).
    PADQOL-16 at baseline and monthly on therapy
    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).
    St. George's Respiratory Questionnaire at baseline and monthly on therapy
    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).

    Full Information

    First Posted
    August 6, 2021
    Last Updated
    September 27, 2023
    Sponsor
    University of Alabama at Birmingham
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05193552
    Brief Title
    Usage of Spirometry in Managing IgG Therapy in CVID With Airway Disease
    Official 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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 15, 2024 (Anticipated)
    Primary Completion Date
    December 2025 (Anticipated)
    Study Completion Date
    December 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Alabama at Birmingham

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Common Variable Immunodeficiency

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    22 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    11 subjects will be treated for 6 months at their current dose of Hizentra
    Arm Title
    Treatment Group
    Arm Type
    Experimental
    Arm Description
    11 subjects 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.
    Intervention Type
    Drug
    Intervention Name(s)
    Hizentra
    Other Intervention Name(s)
    SQ gammaglobulin therapy
    Intervention Description
    subjects level of IGRT will be adjusted for bioavailability as per manufacturer's instructions
    Primary Outcome Measure Information:
    Title
    FEV1 at baseline
    Description
    Pulmonary function will be measured by forced expiratory volume in one second (FEV1) at baseline.
    Time Frame
    baseline
    Title
    FEV1 at 3 months
    Description
    Pulmonary function will be measured by forced expiratory volume in one second (FEV1) at three months into the study.
    Time Frame
    3 months
    Title
    FEV1 at 6 months.
    Description
    Pulmonary function will be measured by forced expiratory volume in one second (FEV1) at six months into the study.
    Time Frame
    6 months
    Title
    FVC at baseline
    Description
    Pulmonary function will be measured by forced vital capacity (FVC) at baseline.
    Time Frame
    baseline
    Title
    FVC at 3 months
    Description
    Pulmonary function will be measured by forced vital capacity (FVC) at three months.
    Time Frame
    3 months
    Title
    FVC at 6 months.
    Description
    Pulmonary function will be measured by forced vital capacity (FVC) at six months.
    Time Frame
    6 months
    Title
    FEF25-75% at baseline
    Description
    Pulmonary function will be measured by forced expiratory flow at 25 and 75% of the pulmonary volume (FEF25-75%) at baseline.
    Time Frame
    baseline
    Title
    FEF25-75% at 3 months
    Description
    Pulmonary function will be measured by forced expiratory flow at 25 and 75% of the pulmonary volume (FEF25-75%) at 3 months.
    Time Frame
    3 months
    Title
    FEF25-75% at 6 months
    Description
    Pulmonary function will be measured by forced expiratory flow at 25 and 75% of the pulmonary volume (FEF25-75%) at six months.
    Time Frame
    6 months
    Title
    FEV1/FVC ratio at baseline
    Description
    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.
    Time Frame
    baseline
    Title
    FEV1/FVC ratio at 3 months
    Description
    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.
    Time Frame
    3 months
    Title
    FEV1/FVC ratio at 6 months
    Description
    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.
    Time Frame
    6 months
    Title
    FOT at baseline.
    Description
    Forced Oscillation Technique (FOT) will be measured at baseline. Forced Oscillation Technique (FOT) measures lung impedance during tidal breathing.
    Time Frame
    baseline
    Title
    FOT at 3 months.
    Description
    Forced Oscillation Technique (FOT) will be measured at 3 months. Forced Oscillation Technique (FOT) measures lung impedance during tidal breathing.
    Time Frame
    3 months
    Title
    FOT at 6 months.
    Description
    Forced Oscillation Technique (FOT) will be measured at 6 months. Forced Oscillation Technique (FOT) measures lung impedance during tidal breathing.
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    FACIT score at baseline and monthly on therapy
    Description
    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).
    Time Frame
    6 months
    Title
    PADQOL-16 at baseline and monthly on therapy
    Description
    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).
    Time Frame
    6 months
    Title
    St. George's Respiratory Questionnaire at baseline and monthly on therapy
    Description
    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).
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Leigh Powell
    Phone
    2053319159
    Email
    lcpowell@uabmc.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tracy Hwangpo, MD/PhD
    Phone
    2059960161
    Email
    thwangpo@uabmc.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Harry Schroeder, MD/PhD
    Organizational Affiliation
    University of Alabama at Birmingham
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Usage of Spirometry in Managing IgG Therapy in CVID With Airway Disease

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