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

NCT05456178 | Completed

• 1 other identifier: 69HCL19_0913
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

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

Keywords

chronic obstructive pulmonary disease; Pulmonary aspergillosis; environmental fungal exposure; electrostatic wipe

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

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

Interventions

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.

Adult subjects with chronic obstructive pulmonary disease

Eligibility Criteria

• Age: 41 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study concerns adult subjects with chronic obstructive pulmonary disease.

You may qualify if:

• 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
• Delivery of enlightened information and collection of non-opposition

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

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

Lyon, 69317, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

3 blood sample of 3.5 ml for: * aspergillosis serology (Aspergillus IgG, total IgE and specific IgE for Cladosporium, Alternaria, Penicillium, Botritis, Fusarium, Candida, Schizophyllum, Curvularia, Bipolaris * Blood count One sample of expectoration for fungal diversity analysis An electrostatic wipe will be left 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.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Pulmonary Aspergillosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Jean MENOTTI, MD

  Service de Parasitologie et Mycologie médicale / Institut des Agents Infectieux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2022
• First Posted: July 13, 2022
• Study Start: July 23, 2021
• Primary Completion: June 29, 2023
• Study Completion: June 29, 2023
• Last Updated: July 19, 2023

Record last verified: 2023-07

Locations

FR (1)