Relationship Between Degree of Domestic Environmental Fungal Exposure and Clinical Symptoms of Patients With Chronic Obstructive Pulmonary Disease

Exposure to Aspergillus spores is associated with symptoms of asthma or airway inflammation (Chaudhary & Marr, 2011; Smith & Denning, 2011), leading to the possible onset of severe fungal complications with acute or chronic inflammation. In patients with chronic obstructive pulmonary disease (COPD), whose main etiological factor is cigarette smoke, A. fumigatus sensitization has been reported to be related to poor lung function (Bafadhel et al., 2014). Besides, COPD patients with fungal sensitization exhibit greater granulocyte count, implying more severe inflammation (Agarwal, Gaur, & Chowdhary, 2015). Fungal cultures from sputum are frequently positive in patients with asthma or with COPD (Pashley, 2014). Fungal colonization and infection have also been suspected to be related to exacerbations of COPD, but their potential role in the pathogenesis of COPD is poorly understood (Bafadhel et al., 2014). The hypothesis is that patients with COPD have a worsening of their pulmonary symptoms after exposure to fungal spores. This study will ensure the feasibility of quantifying environmental fungal exposure in patients' dwellings. For this, an electrostatic wipe will be deposited in the living room and another one in the bedroom for 12 weeks. The wipes will be analyzed by the mycology laboratory of the Croix Rousse hospital.

If the results of this first study are conclusive, it is planned to continue this analysis with a regional multicentre study.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Aspergillosis Bacterial Infections and Mycoses Chronic Disease Disease Attributes Infections Lung Diseases Lung Diseases, Fungal Lung Diseases, Obstructive Mycoses Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Aspergillosis Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

41 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de Parasitologie et Mycologie médicale / Institut des Agents Infectieux, Hôpital de la Croix-Rousse, HCL

Lyon, 69317, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Male or female aged over 40
Suffering from COPD (chronic obstructive pulmonary disease), diagnosed by a pulmonologist
Presence of bronchial obstruction with FEV1 (Forced expiratory volume)/FVC (Forced vital capacity) <70%
FEV reversibility post β2-mimetic < 12% and < 200 ml (vs FEV prebronchodilator)
Smoking ≥ 10 PA active or not
Occupied the same residence for at least 12 months
No changes to the home or recent work in the 6 months preceding inclusion
Delivery of enlightened information and collection of non-opposition

Exclusion criteria

Other chronic respiratory diseases: asthma, bronchiectasis,
bronchial cancer, pulmonary fibrosis, diseases requiring the use of immunosuppressive treatment or biotherapy, or any long-term treatment with oral corticosteroids used for the treatment of a disease other than COPD
COPD exacerbation of less than 4 weeks
Treatment with inhaled corticosteroids alone,
Long-term treatment with oral corticosteroids
Persons deprived of liberty by a judicial or administrative decision,
people undergoing psychiatric care, people admitted to a health or social establishment for purposes other than research
Adults subject to a legal protection measure
Patient enrolled in interventional research excluding routine care research (former regulations) and category 2 research that does not interfere with the analysis of the primary endpoint

Treatment and study plan

Electrostatic wipe

Other

The main objective will be to study the feasibility of the quantification of domestic fungal exposure with electrostatic wipe. The interval of environmental fungal exposure quantification values measured by conventional mycology and by NGS will be established, with analysis of the correlation between the quantification obtained by the two techniques.

For this, an electrostatic wipe will be deposited in the living room and another one in the bedroom for 12 weeks. The wipes will be analyzed by the mycology laboratory of the Croix Rousse hospital.

Primary outcomes

Quantification of domestic fungal exposure.

Time frame: 12 weeks after inclusion.

The main judgment criterion will be to study the feasibility of the quantification of domestic fungal exposure.

Fungal diversity exposure will be analyzed by mycological culture and next-generation sequencing.

The interval of environmental fungal exposure quantification values measured by conventional mycology and by Next Generation Sequençing will be established, with analysis of the correlation between the quantification obtained by the two techniques.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Evaluation of the Relationship Between the Degree of Environmental Fungal Exposure in Patients' Dwellings and Clinical Symptoms of Patients With Chronic Obstructive Pulmonary Disease - Study of Feasibility

Acronym: BPCO-Myc

Important dates

Study start: 2021
Primary completion: 2023
Study completion: 2023
First posted: Jul 13, 2022
Registry last updated: Jul 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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