Clinical trial NCT05456178: Relationship Between Degree of Domestic Environmental Fungal Exposure and Clinical Symptoms of Patients With Chronic Obstructive Pulmonary Disease
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: chronic obstructive pulmonary disease
Pulmonary aspergillosis
environmental fungal exposure
electrostatic wipe
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2022-07-13
Enrollment: 63
Sex: ALL
Minimum age (years): 41
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study concerns adult subjects with chronic obstructive pulmonary disease.

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.


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

Primary outcomes:
measure: Quantification of domestic fungal exposure.
timeFrame: 12 weeks after inclusion.
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Service de Parasitologie et Mycologie médicale / Institut des Agents Infectieux, Hôpital de la Croix-Rousse, HCL
Study officials:
affiliation: Service de Parasitologie et Mycologie médicale / Institut des Agents Infectieux
name: Jean MENOTTI, MD
role: PRINCIPAL_INVESTIGATOR
References: