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OpenTrials
Completed

NCT Number: NCT04081740

Biological Determinants of Sputum Rheology in Chronic Airway Diseases

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

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Measurement of crossover stress (mucus rheology)

    Time frame: Day 0

    The crossover stress point for each mucus sample will be measured in Pa.

Secondary outcomes

  1. Measurement of the storage modulus (mucus rheology)

    Time frame: Day 0

    The storage modulus point for each mucus sample will be measured in Pa.

  2. Measurement of the loss modulus (mucus rheology)

    Time frame: Day 0

    The loss modulus point for each mucus sample will be measured in Pa.

  3. Measurement of the strain crossover (mucus rheology)

    Time frame: Day 0

    The strain crossover point for each mucus sample will be measured in Pa.

  4. Measurement of the loss factor (mucus rheology)

    Time frame: Day 0

    The loss factor point for each mucus sample will be measured as a tangent to an angle in radians.

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • APARD Fonds de dotation

Registry information

Acronym: CADRhé

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 9, 2019
Registry last updated
Nov 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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