Chronic Obstructive Pulmonary DiseaseBPCO-MycNCT05456178
Relationship Between Degree of Domestic Environmental Fungal Exposure and Clinical Symptoms of Patients With Chronic Obstructive Pulmonary Disease
An observational study of Chronic Obstructive Pulmonary Disease, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 41 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Electrostatic wipe
- How many people
- 63 participants
- Where
- 1 siteFrance
- Study dates
- 23 Jul 2021to 29 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 41 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study concerns adult subjects with chronic obstructive pulmonary disease.
Who may be able to join
- 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
Who cannot join
- 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,
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- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Parasitologie et Mycologie médicale / Institut des Agents Infectieux, Hôpital de la Croix-Rousse, HCL
Lyon, 69317
About this study
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
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
- Being tested
- Electrostatic wipe
- Keywords
- chronic obstructive pulmonary disease, Pulmonary aspergillosis, environmental fungal exposure, electrostatic wipe
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Pulmonary Aspergillosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrostatic wipeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Electrostatic wipe |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks after inclusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start23 Jul 2021
- Primary completion29 Jun 2023
- Study completion29 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean MENOTTI, MD, Principal investigator, Service de Parasitologie et Mycologie médicale / Institut des Agents Infectieux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05456178
- Sponsor's protocol ID
- 69HCL19_0913
- Acronym
- BPCO-Myc
- Status last verified
- Jul 2023
- First submitted
- 8 Jul 2022
- Last updated
- 19 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05456178
- Acronym / sponsor ID
- BPCO-Myc / 69HCL19_0913
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- chronic obstructive pulmonary disease, Pulmonary aspergillosis, environmental fungal exposure, electrostatic wipe
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 23 Jul 2021 (actual)
- Primary completion
- 29 Jun 2023 (actual)
- Study completion
- 29 Jun 2023 (actual)
- First posted
- 13 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult subjects with chronic obstructive pulmonary disease | – | Other: Electrostatic wipeIn 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. |
Who may qualify
- Ages
- 41 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study concerns adult subjects with chronic obstructive pulmonary disease.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrostatic wipeThe 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. | Other | Adult subjects with chronic obstructive pulmonary disease |
Primary outcome
Quantification of domestic fungal exposure.
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean MENOTTI, MD principal investigator
Service de Parasitologie et Mycologie médicale / Institut des Agents Infectieux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification of domestic fungal exposure. (time frame: 12 weeks after inclusion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2023.