Drivers of Eosinophilic COPD Exacerbations

NCT04961060 | Unknown

• 1 other identifier: NL75151.042.20
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

Main objective: investigate gene expression differences in nasal epithelium and sputum between eosinophilic COPD exacerbations and other subtypes.

Conditions

COPD Exacerbation; Eosinophilia

Outcome Measures

Primary Outcomes (2)

• Change in gene expression profiles in sputum by RNA sequencing

  Change in gene expression profiles in sputum between the four groups using RNA sequencing. The differences between the expression levels of transcripts (counts) will be analyzed.

  At admission and after 6-8 weeks after discharge.

• Change in gene expression profiles in nasal epithelium by using RNA sequencing

  Change in gene expression profilesin nasal epithelium between the four groups using RNA sequencing. The differences between the expression levels of transcripts (counts) will be analyzed.

  At admission and after 6-8 weeks after discharge.

Secondary Outcomes (6)

• Microbiome composition in sputum by using RNA sequencing.

  At admission, at day 5 of admission and 6-8 weeks after discharge.

• Phenotype blood cell population by flow cytometry.

  At admission, at day 5 of admission and 6-8 weeks after discharge.

• Phenotypic analysis of the T cell compartment by staining of whole blood or isolated peripheral blood mononuclear cells using antibodies

  At admission, at day 5 of admission and 6-8 weeks after discharge.

• Comparison of microbiome composition in sputum and nasal epithelial material by RNA sequencing.

  At admission and 6-8 weeks after discharge.

• Clinical differences between groups by the COPD Assessment Test (CAT).

  Every day of hospital admission.

Study Arms (4)

Eosinophilic exacerbation

COPD exacerbation associated with eosinophilia.

Viral exacerbation

COPD exacerbation associated with viral infection.

Bacterial exacerbation

COPD exacerbation associated bacterial infection.

Pauci-inflammatory exacerbation

Pauci-inflammatory COPD exacerbation

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the UMCG or MUMC for a COPD exacerbation.

You may qualify if:

• COPD patient admitted to the hospital for an acute exacerbation of COPD
• Physician diagnosed COPD according to the GOLD 2020 guidelines, including symptoms consistent with COPD, post-bronchodilator FEV1 \< 80% predicted and FEV1/FVC \< 70%.
• Age \> 40 years.
• Smoker or ex-smoker, ≥ 10 pack years of smoking.

You may not qualify if:

• Current asthma, or prior physician diagnosis of asthma without a symptom- free interval of at least 10 years before the age of 40.
• Chronic use of prednisolone.
• Use of systemic corticosteroids ≥4 days prior to hospital admission.
• Necessity (upon hospitalization) for non-invasive ventilation or ICU admission.
• Pneumonia at presentation documented by chest roentgenography.
• Any other clinically relevant lung disease deemed to interfere with the concept of the study design.
• Allergy to systemic corticosteroids or to antibiotics.
• Females of childbearing potential without an efficient contraception unless they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH \>40 mIU/mL or the use of one or more of the following acceptable methods of contraception:
• Surgical sterilization (e.g. bilateral tubal ligation, hysterectomy).
• Hormonal contraception (implantable, patch, oral, injectable).
• Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/cream/suppository.
• Continuous abstinence
• Pregnancy or lactation.
• Known immunodeficiency.
• Life expectancy less than 60 days

Sponsors & Collaborators

• University Medical Center Groningen: lead
• Maastricht University: collaborator
• GlaxoSmithKline: collaborator

Study Sites (2)

University Maastricht

Maastricht, Limburg, 6229 GT, Netherlands

NOT YET RECRUITING

Univesity Medical Center Groningen

Groningen, 9713 GZ, Netherlands

RECRUITING

Related Publications (19)

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Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Eosinophilia

Condition Hierarchy (Ancestors)

Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Maarten van den Berge, PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa H van Smoorenburg, MSc.

CONTACT

+3150 361 6102; l.h.van.smoorenburg@umcg.nl

Maarten van den Berge, PhD

CONTACT

+3150 361 52 60; m.van.den.berge@umcg.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: July 14, 2021
• Study Start: July 1, 2021
• Primary Completion: September 1, 2024
• Study Completion: January 1, 2025
• Last Updated: July 14, 2021

Record last verified: 2021-07

Locations

NL (2)