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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04081740
Other study ID # RECHMPL19_0430
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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