COPD AsthmaNCT03056066
Accuracy of Spircare Device as Compared to the Conventional Plethysmograph
An observational study of COPD Asthma and Pulmonary Fibrosis, run by Spircare Ltd. at 1 site in Israel.
Trial summary
The purpose of this study is to assess the accuracy of FRC and airway resistance calculate values of Spircare device as compared to the conventional body plethysmograph in healthy adults and patients with obstructive and restrictive pulmonary diseases/disorders. 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, Pulmonary Fibrosis
- What is being tested?
- Plethysmograph
- Type of treatment
- Medical device
- How many people
- 90 participants
- Where
- 1 siteIsrael
- Study dates
- 31 Jul 2017to Jan 2019
- Phase
- Observational
- 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
Study population: Phase I Health subjects without respiratory system disease. Phase II Subjects which are referred to a Pulmonary Functional Testing in the Meir pulmonary unit.
Who may be able to join
- Signed Informed consent.
- Age≥18 year.
- Subject is cooperative and capable of following instructions.
- Phase I: Healthy asymptomatic subjects, never smokers without known history of respiratory, cardiovascular, hepatic, renal or metabolic disease.
- Phase II: Chronic pulmonary patients with lung volume disorders:
- COPD
- Asthma
- Restrictive diseases such as pulmonary fibrosis, other interstitial lung diseases, kyphoscoliosis, neuro-muscular disorders.
Who cannot join
- Subjects unable or unwilling to give informed consent.
- Subjects who are unable to satisfactorily perform routine, full lung function testing (due to non-compliance or claustrophobia).
- History suggesting upper respiratory infection during the four weeks prior to testing
- Physical activity during 1 hour prior to the Study.
- Patients with a tracheostomy.
- Pregnant women.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to assess the accuracy of FRC and airway resistance calculate values of Spircare device as compared to the conventional body plethysmograph in healthy adults and patients with obstructive and restrictive pulmonary diseases/disorders.
- Conditions
- COPD Asthma, Pulmonary Fibrosis
- Being tested
- Plethysmograph
- Medical subject headings
- Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlethysmographDevice
A full Body Plethysmography examination
What is being measured
The primary outcome is the main question the study is designed to answer.
The FRC and air way resistance values of the body plethysmograph will be compared to the values of the Spircare device
The primary outcome of the FRC and air way resistance of the Spircare device against the plethysmograph will be displayed as scatter plot. A linear regression and the R2 value will be display as well. The associated Bland-Altman plots comparing the FRC and airway resistance of the Spircare device to the plethysmograph with lines that represent width of 0.1 (±1.96*SD).
Measured: September 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2017
- Study start31 Jul 2017
- Primary completionNov 2018 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD AsthmaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spircare Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03056066
- Sponsor's protocol ID
- DA-1
- Status last verified
- Apr 2018
- First submitted
- 13 Feb 2017
- Last updated
- 1 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Spircare Device as Compared to the Conventional Plethysmograph
- ClinicalTrials.gov ID
- NCT03056066
- Acronym / sponsor ID
- DA-1
- Conditions
- COPD Asthma, Pulmonary Fibrosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Spircare Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Jul 2017 (actual)
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 17 Feb 2017 (actual)
- 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.
The purpose of this study is to assess the accuracy of FRC and airway resistance calculate values of Spircare device as compared to the conventional body plethysmograph in healthy adults and patients with obstructive and restrictive pulmonary diseases/disorders.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Phase I Health subjects without respiratory system disease. Phase II Subjects which are referred to a Pulmonary Functional Testing in the Meir pulmonary unit.
Key inclusion criteria (8 listed)
- Signed Informed consent.
- Age≥18 year.
- Subject is cooperative and capable of following instructions.
- Phase I: Healthy asymptomatic subjects, never smokers without known history of respiratory, cardiovascular, hepatic, renal or metabolic disease.
- Phase II: Chronic pulmonary patients with lung volume disorders:
Key exclusion criteria (6 listed)
- Subjects unable or unwilling to give informed consent.
- Subjects who are unable to satisfactorily perform routine, full lung function testing (due to non-compliance or claustrophobia).
- History suggesting upper respiratory infection during the four weeks prior to testing
- Physical activity during 1 hour prior to the Study.
- Patients with a tracheostomy.
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 |
|---|---|---|
| PlethysmographA full Body Plethysmography examination | Device | – |
Primary outcome
The FRC and air way resistance values of the body plethysmograph will be compared to the values of the Spircare device
Time frame: September 2017
The primary outcome of the FRC and air way resistance of the Spircare device against the plethysmograph will be displayed as scatter plot. A linear regression and the R2 value will be display as well. The associated Bland-Altman plots comparing the FRC and airway resistance of the Spircare device to the plethysmograph with lines that represent width of 0.1 (±1.96*SD).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2018.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of COPD Asthma and Pulmonary Fibrosis, run by Spircare Ltd. at 1 site in Israel.
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 8 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 1 May 2018. 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 Israel. 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?
Results are not available in the source record.
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?
The FRC and air way resistance values of the body plethysmograph will be compared to the values of the Spircare device (time frame: September 2017). 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 1 May 2018.