Biological Determinants of Sputum Rheology in Chronic Airway Diseases
CADRhé
1 other identifier
observational
48
1 country
1
Brief Summary
The primary objective of this study is to investigate the biological determinants of sputum rheology variations.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 4, 2019
CompletedFirst Posted
Study publicly available on registry
September 9, 2019
CompletedStudy Start
First participant enrolled
September 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 15, 2019
CompletedNovember 7, 2019
November 1, 2019
1 month
September 4, 2019
November 5, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Measurement of crossover stress (mucus rheology)
The crossover stress point for each mucus sample will be measured in Pa.
Day 0
Secondary Outcomes (4)
Measurement of the storage modulus (mucus rheology)
Day 0
Measurement of the loss modulus (mucus rheology)
Day 0
Measurement of the strain crossover (mucus rheology)
Day 0
Measurement of the loss factor (mucus rheology)
Day 0
Study Arms (3)
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.
Eligibility Criteria
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.
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
- Patients under any type of legal guardianship
- Prisoners
- Impossible to correctly inform the patient
- Does not fluently read French
- Emergency situations
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Montpellierlead
- APARD Fonds de dotationcollaborator
Study Sites (1)
Arnaud de Villeneuve Hospital
Montpellier, 34295, France
Related Publications (1)
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.
PMID: 35843096DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mathilde Volpato, MS
University Hospitals of Montpellier
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 4, 2019
First Posted
September 9, 2019
Study Start
September 15, 2019
Primary Completion
October 15, 2019
Study Completion
October 15, 2019
Last Updated
November 7, 2019
Record last verified: 2019-11
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Requests for individual datasets can be made anytime following full publication of results.
- Access Criteria
- Due to French law there are restrictions on publicly sharing the data of this study. Data requests may be submitted to the study sponsor and must be approved by the French data protection authority (la Commission Nationale de l'Informatique et des Libertés (CNIL)). French law requires that everyone who wishes to access clinical study data on humans must ask the CNIL for permission. For further information, please see: https://www.cnil.fr/.
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.