Biological Determinants of Sputum Rheology in Chronic Airway Diseases

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Brief Title

Biological Determinants of Sputum Rheology in Chronic Airway Diseases

Official Title

Biological Determinants of Sputum Rheology in Chronic Airway Diseases

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 Type

Observational

Primary Outcome

Measurement of crossover stress (mucus rheology)

Secondary Outcome

 Measurement of the storage modulus (mucus rheology)

Condition

Asthma

Study Arms / Comparison Groups

 Asthma
Description:  The patients included in this group will have asthma, as specified in the inclusion criteria.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Estimated Enrollment

48

Start Date

September 15, 2019

Completion Date

October 15, 2019

Primary Completion Date

October 15, 2019

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

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Mathilde Volpato, MS, ,

Location Countries

France

Location Countries

France

Administrative Informations

NCT ID

NCT04081740

Organization ID

RECHMPL19_0430

Responsible Party

Sponsor

Study Sponsor

University Hospital, Montpellier

Collaborators

 APARD Fonds de dotation

Study Sponsor

Mathilde Volpato, MS, Principal Investigator, University Hospitals of Montpellier

Verification Date

November 2019