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

Chronic Obstructive Pulmonary Disease Clinical Trial

— BPCO-Myc  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05456178
• Other study ID #: 69HCL19_0913
• Status: Completed
• Start date: July 23, 2021
• Est. completion date: June 29, 2023

Study information

• Verified date: July 2023
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: June 29, 2023
• Est. primary completion date: June 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 41 Years and older

Eligibility

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 ß2-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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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.

Locations

Country	Name	City	State
France	Service de Parasitologie et Mycologie médicale / Institut des Agents Infectieux, Hôpital de la Croix-Rousse, HCL	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.