AsthmaCADRhéNCT04081740
Biological Determinants of Sputum Rheology in Chronic Airway Diseases
An observational study of Asthma and COPD, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The primary objective of this study is to investigate the biological determinants of sputum rheology variations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma, COPD, Bronchiectasis
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- 15 Sep 2019to 15 Oct 2019
- 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: The study population corresponds to patients with a chronic airway disease (asthma, chronic obstructive pulmonary disease (COPD) or bronchiectasis) present at the study centre and capable of spontaneous mucus expectoration.
Who may be able to join
- Affiliate with or beneficiary of the French national single-payer health insurance system
- Patient capable of spontaneous mucus expectoration
- Consulting or hospitalized at the study centre
- Never- or former-smoker (<10 pack-years)
- Medical history compatible with asthma
- Reversible post-brochodilator (or post-corticosteroid test) ventilatory obstruction (ratio of forced expiratory volume in 1 second : forced vital capacity < 70%) or significant variation in respiratory function -- OR -- Bronchial hyperresponsiveness demonstrated during a broncho-provocation test
Show all 10Show fewer
- Current- or former-smokers (>10 pack years)
- Chronic obstructive pulmonary disease according to GOLD criteria
- Presence of bronchiectasis on computed tomography scan
- Cystic fibrosis has been ruled out
Who cannot join
- Patient expresses opposition to the protocol
- Breast feeding or pregnant
- Metastatic neoplastic disease
- Other active pulmonary disease (tuberculosis, interstitial lung disease)
- Recent psychiatric disorder (in the past year and documented via a specialist consult)
- Consumption of illicit drugs or alcoholism
Show all 12Show fewer
- Patients in an exclusion period determined by another study
- Patients under any type of legal guardianship
- Prisoners
- Impossible to correctly inform the patient
- Does not fluently read French
- Emergency situations
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of this study is to investigate the biological determinants of sputum rheology variations.
Read the detailed description
Secondarily, this study aims to compare rheology parameters between different chronic airway disease sub-populations.
- Conditions
- Asthma, COPD, Bronchiectasis
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive, Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Asthma | The patients included in this group will have asthma, as specified in the inclusion criteria. | |
| COPD | The patients included in this group will have COPD, as specified in the inclusion criteria. | |
| Bronchiectasis | The patients included in this group will have bronchiectasis, as specified in the inclusion criteria. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of crossover stress (mucus rheology)
The crossover stress point for each mucus sample will be measured in Pa.
Measured: Day 0
Secondary outcomes (4)
Measurement of the storage modulus (mucus rheology)
The storage modulus point for each mucus sample will be measured in Pa.
Measured: Day 0
Measurement of the loss modulus (mucus rheology)
The loss modulus point for each mucus sample will be measured in Pa.
Measured: Day 0
Measurement of the strain crossover (mucus rheology)
The strain crossover point for each mucus sample will be measured in Pa.
Measured: Day 0
Measurement of the loss factor (mucus rheology)
The loss factor point for each mucus sample will be measured as a tangent to an angle in radians.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start15 Sep 2019
- Primary completion15 Oct 2019
- Study completion15 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Retrospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- APARD Fonds de dotation
- Responsible party
- Sponsor
- Investigators
- Mathilde Volpato, MS, Principal investigator, University Hospitals of Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04081740
- Sponsor's protocol ID
- RECHMPL19_0430
- Acronym
- CADRhé
- Status last verified
- Nov 2019
- First submitted
- 4 Sep 2019
- Last updated
- 7 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The general goal is to, in as much as possible, make the study data available to interested researchers as well as to provide proof of transparency for the study. Data (and an accompanying data dictionary) will be de-identified and potentially further cleaned or aggregated as the investigators deem necessary to protect participant anonymity. Due to conditions imposed by French law, data will be made available to the public upon request to the study sponsor and fulfilment of French legal requirements.
Publications
Volpato M, Vialaret J, Hirtz C, Petit A, Suehs C, Patarin J, Matzner-Lober E, Vachier I, Molinari N, Bourdin A, Charriot J. Rheology predicts sputum eosinophilia in patients with muco-obstructive lung diseases. Biochem Biophys Res Commun. 2022 Sep 24;622:64-71. doi: 10.1016/j.bbrc.2022.07.025. Epub 2022 Jul 11.
PubMed 35843096
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological Determinants of Sputum Rheology in Chronic Airway Diseases
- ClinicalTrials.gov ID
- NCT04081740
- Acronym / sponsor ID
- CADRhé / RECHMPL19_0430
- Conditions
- Asthma, COPD, Bronchiectasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- APARD Fonds de dotation
- Study start
- 15 Sep 2019 (actual)
- Primary completion
- 15 Oct 2019 (actual)
- Study completion
- 15 Oct 2019 (actual)
- First posted
- 9 Sep 2019 (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.
The primary objective of this study is to investigate the biological determinants of sputum rheology variations.
Detailed description
Secondarily, this study aims to compare rheology parameters between different chronic airway disease sub-populations.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Asthma | – | –The patients included in this group will have asthma, as specified in the inclusion criteria. |
| COPD | – | –The patients included in this group will have COPD, as specified in the inclusion criteria. |
| Bronchiectasis | – | –The patients included in this group will have bronchiectasis, as specified in the inclusion criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population corresponds to patients with a chronic airway disease (asthma, chronic obstructive pulmonary disease (COPD) or bronchiectasis) present at the study centre and capable of spontaneous mucus expectoration.
Key inclusion criteria (10 listed)
- Affiliate with or beneficiary of the French national single-payer health insurance system
- Patient capable of spontaneous mucus expectoration
- Consulting or hospitalized at the study centre
- Never- or former-smoker (<10 pack-years)
- Medical history compatible with asthma
Key exclusion criteria (12 listed)
- Patient expresses opposition to the protocol
- Breast feeding or pregnant
- Metastatic neoplastic disease
- Other active pulmonary disease (tuberculosis, interstitial lung disease)
- Recent psychiatric disorder (in the past year and documented via a specialist consult)
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
Measurement of crossover stress (mucus rheology)
Time frame: Day 0
The crossover stress point for each mucus sample will be measured in Pa.
4 secondary outcomes
Measurement of the storage modulus (mucus rheology)
Time frame: Day 0
Measurement of the loss modulus (mucus rheology)
Time frame: Day 0
Measurement of the strain crossover (mucus rheology)
Time frame: Day 0
Measurement of the loss factor (mucus rheology)
Time frame: Day 0
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 7 Nov 2019.
- Derived from this study: PubMed 35843096Volpato M, Vialaret J, Hirtz C, Petit A, Suehs C, Patarin J, Matzner-Lober E, Vachier I, Molinari N, Bourdin A, Charriot J. Rheology predicts sputum eosinophilia in patients with muco-obstructive lung diseases. Biochem Biophys Res Commun. 2022 Sep 24;622:64-71. doi: 10.1016/j.bbrc.2022.07.025. Epub 2022 Jul 11.
- Individual participant dataSharing planned: Yes. The general goal is to, in as much as possible, make the study data available to interested researchers as well as to provide proof of transparency for the study. Data (and an accompanying data dictionary) will be de-identified and potentially further cleaned or aggregated as the investigators deem necessary to protect participant anonymity. Due to conditions imposed by French law, data will be made available to the public upon request to the study sponsor and fulfilment of French legal requirements.
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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.
Mathilde Volpato, MS principal investigator
University Hospitals of Montpellier
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 Asthma and COPD, run by University Hospital, Montpellier 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 10 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 7 Nov 2019. 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?
Measurement of crossover stress (mucus rheology) (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04081740, which also lists 1 linked publication.
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 7 Nov 2019.