Primary Immunodeficiency Clinical Trial
— PREDDICHAOfficial title:
Bronchiectasis Prevalence in Patients With Primary Humoral Immunodefiency in Champagne-Ardenne Region, France
Primary humoral immunodeficiency (PHID), such as common variable immunodefiency, are the most common symptomatic primary immunodeficiency in adults, in France. Patients are more prone to infections (particularly bacterial upper and lower respiratory tract infections), auto-immunity and atopic manifestations. Morbidity and mortality in PHID are mainly linked to the presence of bronchiectasis, which can lead to infections and to chronic respiratory failure. However, bronchiectasis in these patients can be asymptomatic for a long time. There is no known predictive factors to identify patients more susceptible to develop bronchiectasis and notably, there was no link between the number of previous infectious episodes and bronchiectasis. A marked IgM deficiency and switched memory B cell deficiency might be associated with bronchiectasis. Thoracic CT-scan is recommended at PHID diagnosis but there is no guideline for follow-up, thus leading to bronchiectasis being under-diagnosis or leading to delayed diagnosis
Status | Recruiting |
Enrollment | 75 |
Est. completion date | November 28, 2025 |
Est. primary completion date | November 28, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | inclusion criteria : - Patients with primary humoral immunodeficiency defined as following : - Common variable immunodeficiency : Marked decreased in IgG seric concentration < 5 g/L and in IgA seric concentration or IgM seric concentration (-2SD), without secondary cause - IgG subclass deficiency : marked decrease (-2SD) in at least one IgG subclass (IgG1, 2, 3 et 4) with or without IgA or IgM deficiency - Selective IgM Deficiency : isolated decrease un IgM seric concentration <0.3g/L, without IgG or IgA deficiency - Adult patients - Patients with or without previously identified pulmonary complications - Patients agreeing to participate to the study - Patients insured under the French social security system Non-inclusion criteria : - Patients< 18 years of age - Patients protected by law - Patients for whom CT scan is not feasible (claustrophobia, obesity…) - Pregnant women |
Country | Name | City | State |
---|---|---|---|
France | Damien JOLLY | Reims |
Lead Sponsor | Collaborator |
---|---|
CHU de Reims |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Thoracic CTscan | non-contrast thin-section thoracic CT-scan, after negative urine pregnancy test for women of childbearing age, allowing to detect presence of bronchiectasis and if present the severity index (Bhalla score) | Day 0 | |
Secondary | Pulmonary Function Test | Measures with plethysmography : Forced Expiratory volume | Day 0 | |
Secondary | Pulmonary Function Test | Measures with plethysmography : DLCO | Day 0 | |
Secondary | Pulmonary Function Test | Measures with plethysmography : Total Lung Capacity | Day 0 | |
Secondary | Pulmonary Function Test | Measures with plethysmography : Residual Volume | Day 0 | |
Secondary | Pulmonary Function Test | Measures with plethysmography : Functional Residual Capacity | Day 0 | |
Secondary | Pulmonary Function Test | Measures with plethysmography : Vital Capacity | Day 0 | |
Secondary | 6 minutes walking test | measurement of maximal distance walked in 6 minutes | Day 0 | |
Secondary | 6 minutes walking test | saturation in oxygen (SpO2) | Day 0 | |
Secondary | 6 minutes walking test | Borg index after test | Day 0 | |
Secondary | 6 minutes walking test | Borg index before test | Day 0 | |
Secondary | Quality of life questionnaires | SF-36 | Day 0 | |
Secondary | Quality of life questionnaires | BHQ | Day 0 | |
Secondary | Immunophenotyping | description of some circulating B and T cells subsets | Day 0 | |
Secondary | Biochemical factors : desmosine seric concentration | Measurement of desmosine seric concentration (a specific marker of elastin degradation) | Day 0 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04561115 -
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Immune Globulin (Human) 10% (Gamunex-C) PEG Process (IVIG-PEG) Compared to Gamunex-C in Participants With Primary Humoral Immunodeficiency
|
Phase 3 | |
Completed |
NCT04566692 -
A Study to Evaluate IGSC 20% Biweekly Dosing in Treatment-Experienced Participants and Loading/Maintenance Dosing in Treatment-Naïve Participants With Primary Immunodeficiency
|
Phase 4 | |
Completed |
NCT01465958 -
Pharmacokinetics, Safety, and Tolerability of Subcutaneous GAMUNEX-C in Pediatric Subjects With Primary Immunodeficiency
|
Phase 4 | |
Completed |
NCT01581593 -
Efficacy and Safety Study of Kedrion IVIG 10% to Treat Subjects With Primary Immunodeficiency (PID)
|
Phase 3 | |
Completed |
NCT02881437 -
IgG Level in Primary Immunodeficiency Switching From Standard SCIG to Every Other Week HyQvia
|
Phase 4 | |
Recruiting |
NCT06092528 -
Investigation of the Effects of Pulmonary Rehabilitation in Children With Primary Immunodeficiency
|
N/A | |
Active, not recruiting |
NCT03576742 -
Severe Immune Cytopenia Registry Www.Sic-reg.Org
|
||
Completed |
NCT03907241 -
CLINICAL PHASE III STUDY TO MONITOR THE SAFETY, TOLERABILITY AND EFFICACY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (OCTANORM) IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES, INCLUDING (BUT NOT LIMITED TO) THOSE WHO HAVE COMPLETED THE SCGAM-01 TRIAL
|
Phase 3 | |
Not yet recruiting |
NCT04902807 -
Conception of a Diagnosis, Prognosis and Therapeutic Decision Tool for Patients With Autoimmunity and Inflammation
|
||
Completed |
NCT02806986 -
Efficacy, Pharmacokinetics, Safety, and Tolerability of IGSC 20% in Subjects With Primary Immunodeficiency
|
Phase 3 | |
Completed |
NCT03339778 -
The Benefit of 5% IVIG for Patients With Primary Immunodeficiency Disorders Who Experience Adverse Events on 10% IVIG Preparations
|
N/A | |
Enrolling by invitation |
NCT00895271 -
Establishing Fibroblast-Derived Cell Lines From Skin Biopsies of Patients With Immunodeficiency or Immunodysregulation Disorders
|
||
Recruiting |
NCT03206099 -
NIAID Centralized Sequencing Protocol
|
||
Completed |
NCT02503293 -
A Study to Compare Quality of Life and Satisfaction in Primary Immunodeficient Patients Treated With Subcutaneous Injections of Gammanorm® 165 mg/mL Administered With Two Different Delivery Devices: Injections Using Pump or Rapid Push
|
Phase 4 | |
Recruiting |
NCT03610802 -
Send-In Sample Collection to Achieve Genetic and Immunologic Characterization of Primary Immunodeficiencies
|
||
Completed |
NCT03815357 -
What is the Incidence of an Immune Disorder in Children With Invasive Pneumococcal Disease (IPD)?
|
||
Completed |
NCT02269163 -
Study of ProMetic BioTherapeutics Immune Globulin Intravenous (Human) 10%
|
Phase 3 | |
Terminated |
NCT03733249 -
Long Term Follow-up Study for Patients Enrolled on the BP-004 Clinical Study
|
Phase 1/Phase 2 | |
Completed |
NCT02604810 -
Safety and Pharmacokinetics of IGSC 20% in Subjects With Primary Immunodeficiency
|
Phase 3 | |
Not yet recruiting |
NCT02123615 -
ASIS for GAMMAGARD in Primary Immunodeficiency
|
Phase 1/Phase 2 |