Biological Determinants of Sputum Rheology in Chronic Airway Diseases

Completed

• Conditions: COPD; Bronchiectasis; Asthma

• Registration Number: NCT04081740
• Lead Sponsor: University Hospital, Montpellier

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.

Study Timeline

• Study First Submitted: 2019-09-04
• Study First Submitted QC: 2019-09-04
• Study First Posted: 2019-09-09
• Study Start: 2019-09-15
• Primary Completion: 2019-10-15
• Study Completion: 2019-10-15
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-05
• Last Update Posted: 2019-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measurement of crossover stress (mucus rheology)	Day 0	The crossover stress point for each mucus sample will be measured in Pa.

Secondary Outcome Measures

Name	Time	Method
Measurement of the storage modulus (mucus rheology)	Day 0	The storage modulus point for each mucus sample will be measured in Pa.
Measurement of the strain crossover (mucus rheology)	Day 0	The strain crossover point for each mucus sample will be measured in Pa.
Measurement of the loss modulus (mucus rheology)	Day 0	The loss modulus point for each mucus sample will be measured in Pa.
Measurement of the loss factor (mucus rheology)	Day 0	The loss factor point for each mucus sample will be measured as a tangent to an angle in radians.

Trial Locations

Locations (1)

Arnaud de Villeneuve Hospital; 🇫🇷 Montpellier, France