Clinical trial NCT04081740: Biological Determinants of Sputum Rheology in Chronic Airway Diseases
Official title: Biological Determinants of Sputum Rheology in Chronic Airway Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
COPD
Bronchiectasis
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: APARD Fonds de dotation
First posted: 2019-09-09
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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.

Brief summary: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Measurement of crossover stress (mucus rheology)
timeFrame: Day 0
Secondary outcomes:
measure: Measurement of the storage modulus (mucus rheology)
timeFrame: Day 0
measure: Measurement of the loss modulus (mucus rheology)
timeFrame: Day 0
measure: Measurement of the strain crossover (mucus rheology)
timeFrame: Day 0
measure: Measurement of the loss factor (mucus rheology)
timeFrame: Day 0
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Arnaud de Villeneuve Hospital
Study officials:
affiliation: University Hospitals of Montpellier
name: Mathilde Volpato, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.