Respiratory Microbiota and Immune Response in CVID

NCT ID: NCT06173128

Last Updated: 2025-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-15

Study Completion Date

2026-02-28

Brief Summary

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Common variable immunodeficiency (CVID) is the most prevalent symptomatic primary immunodeficiency. Respiratory ailments are the most frequent complications of CVID, with chronic pulmonary disease developing in 30-60% and even more experiencing frequent acute respiratory infections. This project aims to establish cutting-edge approaches to study pulmonary biology in CVID and apply novel bioinformatics strategies to study complex interactions among microbes and host cells by direct sampling of the respiratory tract. The central hypothesis for this research is that antibody (Ab) deficiency in CVID alters respiratory microbiota and host interactions to drive pulmonary disease.

Detailed Description

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Conditions

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CVID

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Antibody deficient participants

Provider referred patients that have antibody deficiency.

No interventions assigned to this group

Controls

Patients without antibody deficiency from the allergy and immunology clinic at Boston Medical Center and from healthy volunteers at the BU School of Medicine.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients with primary antibody deficiency diagnosed by their treating physician
* Controls will not have a diagnosis of immunodeficiency of any sort
* Male and female patients will be enrolled evenly

Exclusion Criteria

* Patients who self identify as pregnant
* Patients with asthma or chronic obstructive pulmonary disease (COPD) that are not well controlled clinically
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Takeda

INDUSTRY

Sponsor Role collaborator

Boston University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul J Maglione, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Boston University Chobanian & Avedisian School of Medicine, Pulmonary Center

Locations

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Boston Medical Center

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Paul J Maglione, MD PhD

Role: CONTACT

617 358 0913

Matthew S Ware, MS

Role: CONTACT

765 437 1305

Facility Contacts

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Paul J Maglione, MD PhD

Role: primary

617-358-0913

Matthew S Ware, MS

Role: backup

Other Identifiers

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H-42779

Identifier Type: -

Identifier Source: org_study_id

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