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

NCT ID: NCT05456178

Last Updated: 2023-07-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 63 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-07-23
• Study Completion Date: 2023-06-29

Brief Summary

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.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Electrostatic wipe

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 41 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean MENOTTI, MD

Role: PRINCIPAL_INVESTIGATOR

Service de Parasitologie et Mycologie médicale / Institut des Agents Infectieux

Locations

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

Lyon, , France

Countries

France

Other Identifiers

69HCL19_0913

Identifier Type: -

Identifier Source: org_study_id