Primary ImmunodeficiencyPREDDICHANCT06355323
Bronchiectasis Prevalence in Patients With Primary Humoral Immunodefiency in Champagne-Ardenne Region, France
A study testing Blood test and chest CT scan in people with Primary Immunodeficiency and Common Variable Immunodeficiency, run by CHU de Reims at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Immunodeficiency, Common Variable Immunodeficiency, Igg Subclass Deficiency
- What is being tested?
- Blood test and chest CT scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteFrance
- Study dates
- 28 Nov 2022to 11 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the detailed description
Common variable immunodeficiency (CVID) and other antibody deficiencies like immunoglobin G subclass deficiency and selective IgM deficiency are the most frequent clinically significant primary immunodeficiencies (PID) in adults. Prevalence in France in 2009 was 2.11/100.000 people.
These immunodeficiencies are characterized by a significant decrease in serum immunoglobulin concentrations and antibodies production. In some patients, qualitative and/or quantitative alterations in B cells repertoire and sometimes in T cells repertoire are observed. Consequently, patients are more prone to bacterial infections, respiratory manifestations, auto-immune diseases, atopic manifestations, neoplastic complications. Respiratory manifestations are the main complication responsible for the morbidity and mortality in PHID. Bronchiectasis are one of the observed pulmonary complications. It is characterized by pathological and permanent dilatation of the airways, as demonstrated by a thoracic CT-scan. Its frequency varies from a study to another, ranging from 20% to 60% in different PHID populations. Some patients with bronchiectasis can be asymptomatic, while others can present daily symptoms of cough and sputum production with periodic worsening of their symptoms (exacerbations). It can lead to chronic respiratory failure, more infectious complications and altered quality of life. Moreover, mortality in patients with bronchiectasis (whatever the cause) is twice as high than in general population.
A thoracic CT-scan is therefore recommended at PHID diagnosis. However, there is no recommendation concerning screening of this complication during follow-up.
Pathophysiology of bronchiectasis in general is described as a cycle of events promoting impaired mucociliary clearance and retention of airways secretions, leading to chronic infection and thus to inflammatory response, leading to abnormal remodeling oh the airways.
To date, it is not known if some PHID patients are more prone to developing bronchiectasis. There is no statistical link with the number of past infectious events. Some studies suggested that patients with lower IgM concentration or lower switched memory B cell might be more at risk.
Concerning T-cell subset, polarization of CD4 T helper cells response as well as T follicular helper implication might be of interest. Indeed, in auto-immune manifestations in patients with primary immunodeficiency, T follicular helper cells (T cells implied in regulation of B -cells response in germinal centers) are sometimes impaired.
Another interesting phenomenon has been described in chronic obstructive pulmonary disease (another pulmonary disease, presenting similar clinical and pathophysiological mechanisms with bronchiectasis), where lung-infiltrating inflammatory cells secrete proteases participating in elastin breakdown a specific marker of elastin degradation genesis of elastin-derived peptides. These peptides modulate CD4+ T cell (T helper) response and pro-inflammatory cytokine production. As inflammatory response in patients with PHID can differ from immunocompetent patients, modulation of pro-inflammatory T helper cell response by elastin-derived peptides might also be different, participating in the abnormal remodeling of the airways.
In the Champagne-Ardenne region, PHID prevalence is high (5.37/100.000 habitants), however, we do not have data concerning bronchiectasis prevalence in this population and its repercussion on respiratory function and quality of life for our patients. Moreover, a better understanding of pathophysiology and factors associated with the presence of bronchiectasis may lead to better and more personalized care (diagnostic and therapeutic).
- Conditions
- Primary Immunodeficiency, Common Variable Immunodeficiency, Igg Subclass Deficiency, Selective IgM Deficiency
- Being tested
- Blood test, chest CT scan
- Medical subject headings
- Primary Immunodeficiency Diseases, Common Variable Immunodeficiency, IgG Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testOther
Blood test
chest CT scanOther
chest CT scan
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Not described Receives: Other: Blood test; Other: chest CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Day 0
Secondary outcomes (14)
Pulmonary Function Test
Measures with plethysmography : Forced Expiratory volume
Measured: Day 0
Pulmonary Function Test
Measures with plethysmography : DLCO
Measured: Day 0
Pulmonary Function Test
Measures with plethysmography : Total Lung Capacity
Measured: Day 0
Pulmonary Function Test
Measures with plethysmography : Residual Volume
Measured: Day 0
Pulmonary Function Test
Measures with plethysmography : Functional Residual Capacity
Measured: Day 0
Pulmonary Function Test
Measures with plethysmography : Vital Capacity
Measured: Day 0
6 minutes walking test
measurement of maximal distance walked in 6 minutes
Measured: Day 0
6 minutes walking test
saturation in oxygen (SpO2)
Measured: Day 0
6 minutes walking test
Borg index after test
Measured: Day 0
6 minutes walking test
Borg index before test
Measured: Day 0
Quality of life questionnaires
SF-36
Measured: Day 0
Quality of life questionnaires
BHQ
Measured: Day 0
Immunophenotyping
description of some circulating B and T cells subsets
Measured: Day 0
Biochemical factors : desmosine seric concentration
Measurement of desmosine seric concentration (a specific marker of elastin degradation)
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start28 Nov 2022
- Primary completion11 Mar 2024
- Study completion11 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary ImmunodeficiencyStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06355323
- Sponsor's protocol ID
- PT22020
- Acronym
- PREDDICHA
- Status last verified
- Dec 2025
- First submitted
- 24 Feb 2023
- Last updated
- 18 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bronchiectasis Prevalence in Patients With Primary Humoral Immunodefiency in Champagne-Ardenne Region, France
- ClinicalTrials.gov ID
- NCT06355323
- Acronym / sponsor ID
- PREDDICHA / PT22020
- Conditions
- Primary Immunodeficiency, Common Variable Immunodeficiency, Igg Subclass Deficiency, Selective IgM Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 28 Nov 2022 (actual)
- Primary completion
- 11 Mar 2024 (actual)
- Study completion
- 11 Mar 2024 (actual)
- First posted
- 9 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Common variable immunodeficiency (CVID) and other antibody deficiencies like immunoglobin G subclass deficiency and selective IgM deficiency are the most frequent clinically significant primary immunodeficiencies (PID) in adults. Prevalence in France in 2009 was 2.11/100.000 people.
These immunodeficiencies are characterized by a significant decrease in serum immunoglobulin concentrations and antibodies production. In some patients, qualitative and/or quantitative alterations in B cells repertoire and sometimes in T cells repertoire are observed. Consequently, patients are more prone to bacterial infections, respiratory manifestations, auto-immune diseases, atopic manifestations, neoplastic complications. Respiratory manifestations are the main complication responsible for the morbidity and mortality in PHID. Bronchiectasis are one of the observed pulmonary complications. It is characterized by pathological and permanent dilatation of the airways, as demonstrated by a thoracic CT-scan. Its frequency varies from a study to another, ranging from 20% to 60% in different PHID populations. Some patients with bronchiectasis can be asymptomatic, while others can present daily symptoms of cough and sputum production with periodic worsening of their symptoms (exacerbations). It can lead to chronic respiratory failure, more infectious complications and altered quality of life. Moreover, mortality in patients with bronchiectasis (whatever the cause) is twice as high than in general population.
A thoracic CT-scan is therefore recommended at PHID diagnosis. However, there is no recommendation concerning screening of this complication during follow-up.
Pathophysiology of bronchiectasis in general is described as a cycle of events promoting impaired mucociliary clearance and retention of airways secretions, leading to chronic infection and thus to inflammatory response, leading to abnormal remodeling oh the airways.
To date, it is not known if some PHID patients are more prone to developing bronchiectasis. There is no statistical link with the number of past infectious events. Some studies suggested that patients with lower IgM concentration or lower switched memory B cell might be more at risk.
Concerning T-cell subset, polarization of CD4 T helper cells response as well as T follicular helper implication might be of interest. Indeed, in auto-immune manifestations in patients with primary immunodeficiency, T follicular helper cells (T cells implied in regulation of B -cells response in germinal centers) are sometimes impaired.
Another interesting phenomenon has been described in chronic obstructive pulmonary disease (another pulmonary disease, presenting similar clinical and pathophysiological mechanisms with bronchiectasis), where lung-infiltrating inflammatory cells secrete proteases participating in elastin breakdown a specific marker of elastin degradation genesis of elastin-derived peptides. These peptides modulate CD4+ T cell (T helper) response and pro-inflammatory cytokine production. As inflammatory response in patients with PHID can differ from immunocompetent patients, modulation of pro-inflammatory T helper cell response by elastin-derived peptides might also be different, participating in the abnormal remodeling of the airways.
In the Champagne-Ardenne region, PHID prevalence is high (5.37/100.000 habitants), however, we do not have data concerning bronchiectasis prevalence in this population and its repercussion on respiratory function and quality of life for our patients. Moreover, a better understanding of pathophysiology and factors associated with the presence of bronchiectasis may lead to better and more personalized care (diagnostic and therapeutic).
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Other: Blood test, Other: chest CT scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients with primary humoral immunodeficiency defined as following :
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood testBlood test | Other | Patients |
| chest CT scanchest CT scan | Other | Patients |
Primary outcome
Thoracic CTscan
Time frame: Day 0
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)
14 secondary outcomes
Pulmonary Function Test
Time frame: Day 0
Pulmonary Function Test
Time frame: Day 0
Pulmonary Function Test
Time frame: Day 0
Pulmonary Function Test
Time frame: Day 0
Pulmonary Function Test
Time frame: Day 0
Pulmonary Function Test
Time frame: Day 0
6 minutes walking test
Time frame: Day 0
6 minutes walking test
Time frame: Day 0
6 minutes walking test
Time frame: Day 0
6 minutes walking test
Time frame: Day 0
Quality of life questionnaires
Time frame: Day 0
Quality of life questionnaires
Time frame: Day 0
Immunophenotyping
Time frame: Day 0
Biochemical factors : desmosine seric concentration
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood test and chest CT scan in people with Primary Immunodeficiency and Common Variable Immunodeficiency, run by CHU de Reims at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thoracic CTscan (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.