COPDRHEOMUCONCT02682290
Assessment of Rheological Parameters of Human Sputum.
A study testing Expectoration and measurement of sputum rheological properties in people with COPD and Asthma, run by University Hospital, Grenoble at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COPD, Asthma, Cystic Fibrosis
- What is being tested?
- Expectoration and measurement of sputum rheological properties
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 3 Mar 2016to 4 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18>BMI>29
- No smoker
- No acute disease in the previous month
- cystic fibrosis with bronchial disorder. Diagnosis confirmed by a reference center
- COPD with FEV1/Forced Vital Capacity (FVC) <70% after administration of a beta-2 agonist
- diagnosis of asthma confirmed by a Pulmonologist
Who cannot join
- asthma, COPD, cystic fibrosis
- contraindications for spirometry
- pregnant woman
- legal exclusion criteria
- 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
Show all 20Show fewer
- contraindications for spirometry
- pregnant woman
- legal exclusion criteria
- 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
- legal exclusion criteria
- Patient with chronic impairment of lung function and/or FEV1≤ 50%.
- Very unstable Asthma
- case of acute exacerbation during the last month
- contraindications for spirometry
- pregnant woman
- legal exclusion criteria
Trial locations and contacts
1 site in 1 country.
France1 site
Centre d'Investigation Clinique - INSERM 1406
Grenoble, Isere, 38043
About this study
Official title: Assessment of a Device Used for Measuring the Rheological Parameters of Human Sputum.
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.
Read the detailed description
This study includes two visits to 48 hours apart.
During the first visit :
- Patients with COPD or cystic fibrosis will have a spontaneous expectoration
- Then all study participants will have an induced expectoration with hypertonic salin solution (4.5%).
During the second visit :
- Patients with COPD or cystic fibrosis will have a spontaneous expectoration
- Then, patients with COPD, asthma and healthy volunteers will have an induced expectoration with hypertonic salin solution (4.5%). Patients with cystic fibrosis will have a spontaneous expectoration 1 hour after an RhDNAse nebulization.
A control spirometry will be perform before each expectoration and during induced expectoration if necessary.
All sputum sample collected will be homogenized and then divided into two equal volumes in order to perform two separate rheological measurements of 15 minutes.
- Conditions
- COPD, Asthma, Cystic Fibrosis
- Being tested
- Expectoration and measurement of sputum rheological properties
- Keywords
- SPUTUM, RHEOLOGY
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma, Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expectoration and measurement of sputum rheological propertiesOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Expectoration and measurement of sputum rheological properties |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Day1 (at the first visit)
Secondary outcomes (4)
Reproducibility of the rheological measurements of human sputum
Comparison between the average of the two rheological measurements preformed at the first visit (Day1) and the average of the two rheological measurements preformed at the second visit (day3) 48 hours later.
Measured: Day3 (48h00 after day1)
Feasibility of the rheological measurements
frequency of measurements failure
Measured: 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)
Measured: 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
During the first visit (day1), for patients with cystic fibrosis: Comparison of rheological parameters before and after nebulization of saline solution.
During second visit (day 3) for patients with cystic fibrosis: Comparison of rheological parameters before and after nebulization of 2.5 ml of RhDNAse.
Measured: Day1 (at the first visit) and day3 (48h00 after day1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2016 (estimated)
- Study start3 Mar 2016
- Primary completion4 Jul 2017
- Study completion4 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02682290
- Sponsor's protocol ID
- 38RC14.444
- Acronym
- RHEOMUCO
- Status last verified
- Oct 2017
- First submitted
- 27 Jan 2016
- Last updated
- 27 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of a Device Used for Measuring the Rheological Parameters of Human Sputum.
- ClinicalTrials.gov ID
- NCT02682290
- Acronym / sponsor ID
- RHEOMUCO / 38RC14.444
- Conditions
- COPD, Asthma, Cystic Fibrosis
- Keywords
- SPUTUM, RHEOLOGY
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 3 Mar 2016 (actual)
- Primary completion
- 4 Jul 2017 (actual)
- Study completion
- 4 Jul 2017 (actual)
- First posted
- 15 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study includes two visits to 48 hours apart.
During the first visit :
- Patients with COPD or cystic fibrosis will have a spontaneous expectoration
- Then all study participants will have an induced expectoration with hypertonic salin solution (4.5%).
During the second visit :
- Patients with COPD or cystic fibrosis will have a spontaneous expectoration
- Then, patients with COPD, asthma and healthy volunteers will have an induced expectoration with hypertonic salin solution (4.5%). Patients with cystic fibrosis will have a spontaneous expectoration 1 hour after an RhDNAse nebulization.
A control spirometry will be perform before each expectoration and during induced expectoration if necessary.
All sputum sample collected will be homogenized and then divided into two equal volumes in order to perform two separate rheological measurements of 15 minutes.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rheological measurement of sputum | Other | Other: Expectoration and measurement of sputum rheological propertiespatients with COPD and patient with cystic fibrosis will perform a spontaneous expectoration. Then all participants will have an induced expectoration with hypertonic salin solution. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18>BMI>29
- No smoker
- No acute disease in the previous month
- cystic fibrosis with bronchial disorder. Diagnosis confirmed by a reference center
- COPD with FEV1/Forced Vital Capacity (FVC) <70% after administration of a beta-2 agonist
Key exclusion criteria (20 listed)
- asthma, COPD, cystic fibrosis
- contraindications for spirometry
- pregnant woman
- legal exclusion criteria
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Expectoration and measurement of sputum rheological properties | Other | rheological measurement of sputum |
Primary outcome
Reproducibility of the rheological measurements of human sputum
Time frame: Day1 (at the first visit)
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)
4 secondary outcomes
Reproducibility of the rheological measurements of human sputum
Time frame: Day3 (48h00 after day1)
Feasibility of the rheological measurements
Time frame: 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)
Time frame: 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
Time frame: Day1 (at the first visit) and day3 (48h00 after day1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expectoration and measurement of sputum rheological properties in people with COPD and Asthma, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reproducibility of the rheological measurements of human sputum (time frame: Day1 (at the first visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2017.