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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

France1 site
  • Damien JOLLY

    Reims

Other trials in France

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).

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 groups in NCT06355323
Study groupRoleWhat they receive
PatientsExperimentalNot 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.

  1. 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)
  1. Pulmonary Function Test

    Measures with plethysmography : Forced Expiratory volume

    Measured: Day 0

  2. Pulmonary Function Test

    Measures with plethysmography : DLCO

    Measured: Day 0

  3. Pulmonary Function Test

    Measures with plethysmography : Total Lung Capacity

    Measured: Day 0

  4. Pulmonary Function Test

    Measures with plethysmography : Residual Volume

    Measured: Day 0

  5. Pulmonary Function Test

    Measures with plethysmography : Functional Residual Capacity

    Measured: Day 0

  6. Pulmonary Function Test

    Measures with plethysmography : Vital Capacity

    Measured: Day 0

  7. 6 minutes walking test

    measurement of maximal distance walked in 6 minutes

    Measured: Day 0

  8. 6 minutes walking test

    saturation in oxygen (SpO2)

    Measured: Day 0

  9. 6 minutes walking test

    Borg index after test

    Measured: Day 0

  10. 6 minutes walking test

    Borg index before test

    Measured: Day 0

  11. Quality of life questionnaires

    SF-36

    Measured: Day 0

  12. Quality of life questionnaires

    BHQ

    Measured: Day 0

  13. Immunophenotyping

    description of some circulating B and T cells subsets

    Measured: Day 0

  14. 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.

  1. First posted9 Apr 2024
  2. Study start28 Nov 2022
  3. Primary completion11 Mar 2024
  4. Study completion11 Mar 2024

Resources

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)
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

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.

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