NCT02682290

Brief Summary

This is a proof of concept study. The aim of this study is to assess a device measuring rheological properties of human sputum of four populations :

  • 10 patients with Broncho Chronic Obstructive Pulmonary Disease (COPD)
  • 10 patients with asthma
  • 10 patients with cystic fibrosis
  • 10 healthy volunteers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 15, 2016

Completed
17 days until next milestone

Study Start

First participant enrolled

March 3, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 4, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 4, 2017

Completed
Last Updated

October 27, 2017

Status Verified

October 1, 2017

Enrollment Period

1.3 years

First QC Date

January 27, 2016

Last Update Submit

October 25, 2017

Conditions

COPDAsthmaCystic Fibrosis

Keywords

SPUTUMRHEOLOGY

Outcome Measures

Primary Outcomes (1)

  • Reproducibility of the rheological measurements of human sputum

    The reproducibility will be assessed during the first visit (Day1). The two rheological measurements performed 15 minutes apart will be compared. Rheological measurements : elastic modulus G' at 0.7Hz, elastic modulus G' at 3Hz, viscous modulus G'' at 0.7Hz, viscous modulus G'' at 3Hz)

    Day1 (at the first visit)

Secondary Outcomes (4)

  • Reproducibility of the rheological measurements of human sputum

    Day3 (48h00 after day1)

  • Feasibility of the rheological measurements

    Day1 (at the first visit) and day3 (48h00 after day1)

  • Comparison of sputum rheological measurements between the four populations studied (healthy volunteers, Asthma, COPD, Cystic Fibrosis)

    Day1 (at the first visit) and day3 (48h00 after day1)

  • Influence of two mucolytic treatments (hypertonic saline solution, RhDNAse) on rheological measurements of patient with cystic fibrosis

    Day1 (at the first visit) and day3 (48h00 after day1)

Study Arms (1)

rheological measurement of sputum

OTHER

patients with COPD and patient with cystic fibrosis will perform a spontaneous expectoration. Then all participants will have an induced expectoration with hypertonic salin solution.

Other: Expectoration and measurement of sputum rheological properties

Interventions

Expectoration and measurement of sputum rheological propertiesOTHER
rheological measurement of sputum

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>BMI\>29
  • No smoker
  • No acute disease in the previous month

You may not qualify if:

  • asthma, COPD, cystic fibrosis
  • contraindications for spirometry
  • pregnant woman
  • \- cystic fibrosis with bronchial disorder. Diagnosis confirmed by a reference center
  • Forced Expiratory Volume in 1 second (FEV1 ) ≤ 40%, contraindications for RhDNAse, patient with chronic impairment of lung function (PaO2\<60 mmHg at rest). Patient who is unable to perform a spontaneous expectoration.
  • case of acute exacerbation during the last month
  • contraindications for spirometry
  • pregnant woman
  • \- COPD with FEV1/Forced Vital Capacity (FVC) \<70% after administration of a beta-2 agonist
  • Patient with chronic impairment of lung function and/or FEV1≤ 40%. Patient who is unable to perform a spontaneous expectoration.
  • case of acute exacerbation during the last month
  • contraindications for spirometry
  • pregnant woman
  • \- diagnosis of asthma confirmed by a Pulmonologist
  • Patient with chronic impairment of lung function and/or FEV1≤ 50%.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre d'Investigation Clinique - INSERM 1406

Grenoble, Isere, 38043, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveAsthmaCystic Fibrosis

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBronchial DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesPancreatic DiseasesDigestive System DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2016

First Posted

February 15, 2016

Study Start

March 3, 2016

Primary Completion

July 4, 2017

Study Completion

July 4, 2017

Last Updated

October 27, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)