Bronchial Mucus in COPD and Cystic FibrosisRHEMUNCT04687319
RHEology of the Pulmonary MUcus
An observational study of Bronchial Mucus in COPD and Cystic Fibrosis, run by University Hospital, Grenoble.
Trial summary
Patients for whom bronchial mucus collection has been performed as part of the treatment will be offered the opportunity to participate in the study. A rheology measurement will be carried out shortly after the collection of fresh bronchial mucus samples. Another part will be done on frozen bronchial mucus samples Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchial Mucus in COPD and Cystic Fibrosis
- What is being tested?
- bronchial mucus collection
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2021to Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient consulting or hospitalised in the pneumology department and for whom an emission of bronchial mucus is planned as part of the treatment
Who may be able to join
- Male or female over 18 years of age.
- Patient consulting or hospitalised in the pneumology department and for whom an emission of bronchial mucus is planned as part of the treatment (mucus from respiratory physiotherapy sessions for patients with cystic fibrosis or COPD, bronchial aspirations from the bronchial fibroscopy programme).
Who cannot join
- Patient being opposed to the use of his mucus samples and data for this research.
- Patient protected by law (guardianship or curatorship), subject deprived of liberty
About this study
Official title: Protocol for the Collection of Lung Mucus Samples From Care for a Rheology Research Programme
Patients for whom bronchial mucus collection has been performed as part of the treatment will be offered the opportunity to participate in the study.
- A rheology measurement will be carried out shortly after the collection of fresh bronchial mucus samples.
- Another part will be done on frozen bronchial mucus samples
- Being tested
- bronchial mucus collection
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bronchial mucus collectionBiological
mucus resulting from respiratory physiotherapy sessions for patients with cystic fibrosis or COPD, bronchial aspirations resulting from the bronchial fibroscopy programme
What is being measured
The primary outcome is the main question the study is designed to answer.
Reproducibility of the rheology parameters studied
Establish operating protocols for obtaining reliable rheological measurements with a view to using them as biomarkers
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study startJan 2021 (estimated)
- Primary completionJan 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchial Mucus in COPD and Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- University Grenoble Alps
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04687319
- Sponsor's protocol ID
- 38RC20.298
- Other IDs
- 2020-A02367-32
- Acronym
- RHEMU
- Status last verified
- Dec 2020
- First submitted
- 7 Dec 2020
- Last updated
- 19 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for the Collection of Lung Mucus Samples From Care for a Rheology Research Programme
- ClinicalTrials.gov ID
- NCT04687319
- Acronym / sponsor ID
- RHEMU / 38RC20.298
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- University Grenoble Alps
- Study start
- Jan 2021 (estimated)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 29 Dec 2020 (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.
Patients for whom bronchial mucus collection has been performed as part of the treatment will be offered the opportunity to participate in the study.
- A rheology measurement will be carried out shortly after the collection of fresh bronchial mucus samples.
- Another part will be done on frozen bronchial mucus samples
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient consulting or hospitalised in the pneumology department and for whom an emission of bronchial mucus is planned as part of the treatment
Key inclusion criteria (2 listed)
- Male or female over 18 years of age.
- Patient consulting or hospitalised in the pneumology department and for whom an emission of bronchial mucus is planned as part of the treatment (mucus from respiratory physiotherapy sessions for patients with cystic fibrosis or COPD, bronchial aspirations from the bronchial fibroscopy programme).
Key exclusion criteria (2 listed)
- Patient being opposed to the use of his mucus samples and data for this research.
- Patient protected by law (guardianship or curatorship), subject deprived of liberty
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 |
|---|---|---|
| bronchial mucus collectionmucus resulting from respiratory physiotherapy sessions for patients with cystic fibrosis or COPD, bronchial aspirations resulting from the bronchial fibroscopy programme | Biological | – |
Primary outcome
Reproducibility of the rheology parameters studied
Time frame: Day 1
Establish operating protocols for obtaining reliable rheological measurements with a view to using them as biomarkers
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchial Mucus in COPD and Cystic Fibrosis, run by University Hospital, Grenoble.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 19 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Reproducibility of the rheology parameters studied (time frame: Day 1). 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 Jan 2021.