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

Common Variable Immunodeficiency Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05193552
• Other study ID #: I300005696
• Status: Recruiting
• Phase: Phase 4
• Start date: January 15, 2024
• Est. completion date: December 2026

Study information

• Verified date: February 2024
• Source: University of Alabama at Birmingham
• Contact: Leigh Powell
• Phone: 2053319159
• Email: lcpowell[@]uabmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Common Variable Immunodeficiency

Intervention

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

Locations

Country	Name	City	State
United States	Community Health 20	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FEV1 at baseline	Pulmonary function will be measured by forced expiratory volume in one second (FEV1) at baseline.	baseline
Primary	FEV1 at 3 months	Pulmonary function will be measured by forced expiratory volume in one second (FEV1) at three months into the study.	3 months
Primary	FEV1 at 6 months.	Pulmonary function will be measured by forced expiratory volume in one second (FEV1) at six months into the study.	6 months
Primary	FVC at baseline	Pulmonary function will be measured by forced vital capacity (FVC) at baseline.	baseline
Primary	FVC at 3 months	Pulmonary function will be measured by forced vital capacity (FVC) at three months.	3 months
Primary	FVC at 6 months.	Pulmonary function will be measured by forced vital capacity (FVC) at six months.	6 months
Primary	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.	baseline
Primary	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.	3 months
Primary	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.	6 months
Primary	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.	baseline
Primary	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.	3 months
Primary	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.	6 months
Primary	FOT at baseline.	Forced Oscillation Technique (FOT) will be measured at baseline. Forced Oscillation Technique (FOT) measures lung impedance during tidal breathing.	baseline
Primary	FOT at 3 months.	Forced Oscillation Technique (FOT) will be measured at 3 months. Forced Oscillation Technique (FOT) measures lung impedance during tidal breathing.	3 months
Primary	FOT at 6 months.	Forced Oscillation Technique (FOT) will be measured at 6 months. Forced Oscillation Technique (FOT) measures lung impedance during tidal breathing.	6 months
Secondary	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).	6 months
Secondary	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).	6 months
Secondary	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).	6 months