Relationship Between Degree of Domestic Environmental Fungal Exposure and Clinical Symptoms of Patients With Chronic Obstructive Pulmonary Disease (BPCO-Myc)

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Other: Electrostatic wipe

• Study Type: Observational
• Enrollment (Actual): 63

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69317
    • Service de Parasitologie et Mycologie médicale / Institut des Agents Infectieux, Hôpital de la Croix-Rousse, HCL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 41 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This study concerns adult subjects with chronic obstructive pulmonary disease.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Adult subjects with chronic obstructive pulmonary disease; In adult patients with chronic obstructive pulmonary disease, an electrostatic wipe will be deposited in the living room and another one in the bedroom for 12 weeks, to be analyzed by the mycology laboratory of the Croix-Rousse hospital, Lyon.

Other: Electrostatic wipe; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantification of domestic fungal exposure.	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.	12 weeks after inclusion.

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Jean MENOTTI, MD, Service de Parasitologie et Mycologie médicale / Institut des Agents Infectieux

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2021
• Primary Completion (Actual): June 29, 2023
• Study Completion (Actual): June 29, 2023

Study Registration Dates

• First Submitted: July 8, 2022
• First Submitted That Met QC Criteria: July 8, 2022
• First Posted (Actual): July 13, 2022

Study Record Updates

• Last Update Posted (Actual): July 19, 2023
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: chronic obstructive pulmonary disease; Pulmonary aspergillosis; environmental fungal exposure; electrostatic wipe
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Chronic Disease; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 69HCL19_0913

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No