COPDFungiCOPDNCT02318524
Clinical Impact of Fungal Domestic Environmental Exposure on COPD Patients
An observational study of COPD and Pulmonary Fungal Diseases, run by University Hospital, Lille at 1 site in France.
Trial summary
Fungal infections could play a role in chronic obstructive pulmonary disease (COPD) patient's exacerbations and in lung function impairment. In fact, Aspergillus fumigatus is often isolated from respiratory samples, but few data are available about its clinical significance. Read more about this study
- Who is it for?
- Ages 35 to 90 years
- Conditions the study is for
- COPD, Pulmonary Fungal Diseases, Environmental Exposure
- How many people
- 65 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2011to Oct 2017
- 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 35 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- 35 to 90 years old male or female,
- COPD patient (I to IV stages),
- Medical consultation or severe COPD exacerbation requiring hospitalization.
Who cannot join
- Active tuberculosis.
- Cancer (or prior anticancer therapy within the past 3 years).
- Diffuse bronchiectasia.
- Cystic fibrosis.
- Asthma.
- Any other pulmonary disease (sarcoidosis, pulmonary fibrosis, pneumoconiosis,…).
Show all 12Show fewer
- Prior anti- P. jirovecii or antifungal treatment within the past 6 months.
- Pregnant or breast-feeding females.
- Patient with no social insurance.
- Patient unwilling to comply with the protocol.
- Patient unable to understand the study and its objectives.
- Patient under guardianship.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Circulation of Pathogenic Fungi in the Domestic Environment: Clinical Impact of Mould and Pneumocystis Jirovecii Exposure on COPD Patients
Fungal infections could play a role in chronic obstructive pulmonary disease (COPD) patient's exacerbations and in lung function impairment. In fact, Aspergillus fumigatus is often isolated from respiratory samples, but few data are available about its clinical significance. Aspergillus colonization could be associated to a higher risk of invasive pulmonary aspergillosis (IPA), which, in COPD patients, is characterized by a 2% incidence (probably underestimated) and a high mortality (72 to 95%). Similarly, detection of anti-Aspergillus antibodies is quite frequent in COPD patients but its significance and usefulness for aspergillosis diagnosis and follow-up have not been assessed. Furthermore, several studies suggest a frequent carriage of Pneumocystis jirovecii, reaching 37-55%, with a higher frequency in the most severe COPD stages and a possible role of colonisation in the occurrence and progression of COPD.
As these colonization and sensitization phenomena could be related to domestic exposure to airborne or, for P. jirovecii, to human reservoirs, the investigators set-up a study in order to (i) Evaluate how domestic exposure to mould or to P. jirovecii could impact fungal colonization and sensitization frequency in COPD patients, (ii) Study the relationship between these fungal colonization/sensitization phenomena and lung function impairment in the course of COPD and (iii) Have a better understanding of mould and P. jirovecii circulation in the close environment of patients (between airborne, human reservoirs and patients).
In fine, this study will provide data (i) On fungal contamination levels (species and conidia concentration) of COPD patient's homes in a French region, (ii) On the relationship between fungal exposure level and colonization/sensitization phenomena, (iii) On the role of fungal colonization/sensitization in lung function impairment, (iv) To design diagnostic, therapeutic, and preventive options for the management of COPD patients, taking into account fungal environmental exposure and colonization/sensitization impact on the evolution of the disease.
Read the detailed description
The investigators will focus on both the patient and its domestic environment. More precisely, for 80 patients, the investigators will measure mould domestic exposure (determination of mould frequency during an environmental investigation at the patient's home), search for mould sensitization and colonization (complete bio clinical check-up including spirometry, inflammatory and mycological markers at inclusion), and do a clinical follow-up of exacerbation's (frequency and severity). At last, clinical and environmental mould and P. jirovecii isolates will be characterized at the phenotypic and genotypic level.
- Conditions
- COPD, Pulmonary Fungal Diseases, Environmental Exposure
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Fungal
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of domestic mould exposure of colonized/sensitized and non colonized/non sensitized COPD patients.
The primary endpoint will be the difference between " colonized/sensitized " and " non colonized/non sensitized " groups in change of mould exposure level. Mould exposure level is a numeric value which corresponds to the concentration of fungal conidia in the dust catcher (measurement by culture and quantitative real-time PCR).
Measured: Mould exposure and colonization/sensitization will be measured at inclusion. Patients will undergo a bioclinical checkup 18 months after inclusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2014 (estimated)
- Study startAug 2011
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Région Nord-Pas de Calais, France, Pfizer, Merck Sharp & Dohme LLC, Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- Emilie Fréalle, PharmD, PhD, Study director, University Hospital, LilleStéphanie Fry, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02318524
- Sponsor's protocol ID
- 2010_35
- Other IDs
- 2010-A01379-30
- Acronym
- FungiCOPD
- Status last verified
- Dec 2017
- First submitted
- 22 Apr 2013
- Last updated
- 22 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulation of Pathogenic Fungi in the Domestic Environment: Clinical Impact of Mould and Pneumocystis Jirovecii Exposure on COPD Patients
- ClinicalTrials.gov ID
- NCT02318524
- Acronym / sponsor ID
- FungiCOPD / 2010_35
- Conditions
- COPD, Pulmonary Fungal Diseases, Environmental Exposure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Région Nord-Pas de Calais, France, Pfizer, Merck Sharp & Dohme LLC, Gilead Sciences
- Study start
- Aug 2011
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 17 Dec 2014 (estimated)
- 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.
Fungal infections could play a role in chronic obstructive pulmonary disease (COPD) patient's exacerbations and in lung function impairment. In fact, Aspergillus fumigatus is often isolated from respiratory samples, but few data are available about its clinical significance. Aspergillus colonization could be associated to a higher risk of invasive pulmonary aspergillosis (IPA), which, in COPD patients, is characterized by a 2% incidence (probably underestimated) and a high mortality (72 to 95%). Similarly, detection of anti-Aspergillus antibodies is quite frequent in COPD patients but its significance and usefulness for aspergillosis diagnosis and follow-up have not been assessed. Furthermore, several studies suggest a frequent carriage of Pneumocystis jirovecii, reaching 37-55%, with a higher frequency in the most severe COPD stages and a possible role of colonisation in the occurrence and progression of COPD.
As these colonization and sensitization phenomena could be related to domestic exposure to airborne or, for P. jirovecii, to human reservoirs, the investigators set-up a study in order to (i) Evaluate how domestic exposure to mould or to P. jirovecii could impact fungal colonization and sensitization frequency in COPD patients, (ii) Study the relationship between these fungal colonization/sensitization phenomena and lung function impairment in the course of COPD and (iii) Have a better understanding of mould and P. jirovecii circulation in the close environment of patients (between airborne, human reservoirs and patients).
In fine, this study will provide data (i) On fungal contamination levels (species and conidia concentration) of COPD patient's homes in a French region, (ii) On the relationship between fungal exposure level and colonization/sensitization phenomena, (iii) On the role of fungal colonization/sensitization in lung function impairment, (iv) To design diagnostic, therapeutic, and preventive options for the management of COPD patients, taking into account fungal environmental exposure and colonization/sensitization impact on the evolution of the disease.
Detailed description
The investigators will focus on both the patient and its domestic environment. More precisely, for 80 patients, the investigators will measure mould domestic exposure (determination of mould frequency during an environmental investigation at the patient's home), search for mould sensitization and colonization (complete bio clinical check-up including spirometry, inflammatory and mycological markers at inclusion), and do a clinical follow-up of exacerbation's (frequency and severity). At last, clinical and environmental mould and P. jirovecii isolates will be characterized at the phenotypic and genotypic level.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 35 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (3 listed)
- 35 to 90 years old male or female,
- COPD patient (I to IV stages),
- Medical consultation or severe COPD exacerbation requiring hospitalization.
Key exclusion criteria (12 listed)
- Active tuberculosis.
- Cancer (or prior anticancer therapy within the past 3 years).
- Diffuse bronchiectasia.
- Cystic fibrosis.
- Asthma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of domestic mould exposure of colonized/sensitized and non colonized/non sensitized COPD patients.
Time frame: Mould exposure and colonization/sensitization will be measured at inclusion. Patients will undergo a bioclinical checkup 18 months after inclusion.
The primary endpoint will be the difference between " colonized/sensitized " and " non colonized/non sensitized " groups in change of mould exposure level. Mould exposure level is a numeric value which corresponds to the concentration of fungal conidia in the dust catcher (measurement by culture and quantitative real-time PCR).
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 22 Dec 2017.
- Individual participant dataSharing planned: No
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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.
Emilie Fréalle, PharmD, PhD study director
University Hospital, Lille
Stéphanie Fry, MD principal investigator
University Hospital, Lille
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 COPD and Pulmonary Fungal Diseases, run by University Hospital, Lille 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 3 inclusion and 12 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 22 Dec 2017. 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?
Comparison of domestic mould exposure of colonized/sensitized and non colonized/non sensitized COPD patients. (time frame: Mould exposure and colonization/sensitization will be measured at inclusion. Patients will undergo a bioclinical checkup 18 months 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 22 Dec 2017.