Biological Determinants of Sputum Rheology in Chronic Airway Diseases (CADRhé)

The primary objective of this study is to investigate the biological determinants of sputum rheology variations.

Study Overview

• Status: Completed
• Conditions: Bronchiectasis; Asthma; COPD

Detailed Description

Secondarily, this study aims to compare rheology parameters between different chronic airway disease sub-populations.

• Study Type: Observational
• Enrollment (Actual): 48

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Arnaud de villeneuve Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• 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

Inclusion Criteria for the Asthma Group

• 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

Inclusion Criteria for the COPD Group

• Current- or former-smokers (>10 pack years)
• Chronic obstructive pulmonary disease according to GOLD criteria

Inclusion Criteria for the Bronchiectasis Group

• Presence of bronchiectasis on computed tomography scan
• Cystic fibrosis has been ruled out

Exclusion Criteria:

• 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 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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of crossover stress (mucus rheology)	The crossover stress point for each mucus sample will be measured in Pa.	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of the storage modulus (mucus rheology)	The storage modulus point for each mucus sample will be measured in Pa.	Day 0
Measurement of the loss modulus (mucus rheology)	The loss modulus point for each mucus sample will be measured in Pa.	Day 0
Measurement of the strain crossover (mucus rheology)	The strain crossover point for each mucus sample will be measured in Pa.	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.	Day 0

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: APARD Fonds de dotation
• Investigators: Principal Investigator: Mathilde Volpato, MS, University Hospitals of Montpellier

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2019
• Primary Completion (Actual): October 15, 2019
• Study Completion (Actual): October 15, 2019

Study Registration Dates

• First Submitted: September 4, 2019
• First Submitted That Met QC Criteria: September 4, 2019
• First Posted (Actual): September 9, 2019

Study Record Updates

• Last Update Posted (Actual): November 7, 2019
• Last Update Submitted That Met QC Criteria: November 5, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchiectasis; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: RECHMPL19_0430

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Requests for individual datasets can be made anytime following full publication of results.
• IPD Sharing 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/.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No