Biological Determinants of Sputum Rheology in Chronic Airway Diseases

Asthma Clinical Trial

— CADRhé  

Official title:

Biological Determinants of Sputum Rheology in Chronic Airway Diseases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04081740
• Other study ID #: RECHMPL19_0430
• Status: Completed
• Start date: September 15, 2019
• Est. completion date: October 15, 2019

Study information

• Verified date: November 2019
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: October 15, 2019
• Est. primary completion date: October 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Bronchiectasis
• COPD
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
France	Arnaud de Villeneuve Hospital	Montpellier

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Montpellier	APARD

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of crossover stress (mucus rheology)	The crossover stress point for each mucus sample will be measured in Pa.	Day 0
Secondary	Measurement of the storage modulus (mucus rheology)	The storage modulus point for each mucus sample will be measured in Pa.	Day 0
Secondary	Measurement of the loss modulus (mucus rheology)	The loss modulus point for each mucus sample will be measured in Pa.	Day 0
Secondary	Measurement of the strain crossover (mucus rheology)	The strain crossover point for each mucus sample will be measured in Pa.	Day 0
Secondary	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