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

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Other: Electrostatic wipe

• Registration Number: NCT05456178
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-07-23
• Study First Submitted: 2022-07-08
• Study First Submitted QC: 2022-07-08
• Study First Posted: 2022-07-13
• Primary Completion: 2023-06-29
• Study Completion: 2023-06-29
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-18
• Last Update Posted: 2023-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adult subjects with chronic obstructive pulmonary disease	Electrostatic wipe	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.

Primary Outcome Measures

Name	Time	Method
Quantification of domestic fungal exposure.	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.

Trial Locations

Locations (1)

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