AsthmaNCT02805114
Obstructive Airways Diseases in Pulmonary Clinic (OADPC) Study
An observational study of Asthma and Chronic Obstructive Pulmonary Disease (COPD), run by Oridion at 1 site in Israel.
Trial summary
This is an observational study which aims to evaluate the possibility of using data from a capnography device to assess obstructive airway severity in both Chronic Obstructive Pulmonary Disease (COPD) and Asthma patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma, Chronic Obstructive Pulmonary Disease (COPD)
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2016to 21 May 2018
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Asthma and COPD patients
Who may be able to join
- Age >18
- Ability and willingness to participate the study and sign informed consent form
- Asthma / COPD patients
Who cannot join
- Pregnant women
- Asthma or COPD patients with FEV1 > 80%
- Disability or unwillingness to undergo capnography measurement
- Cannot be assessed for FEV1
- Oxygen supply >5 L/min
- 6. Subjects that gone through LOBECTOMY OF LUNG in the last 5 years.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Pulmonary Institute Rabin Medical center, Beilinson Hospital
Petah Tikva, 49100
About this study
This is an observational study which aims to evaluate the possibility of using data from a capnography device to assess obstructive airway severity in both Chronic Obstructive Pulmonary Disease (COPD) and Asthma patients.
Read the detailed description
This is an observational study which aims to evaluate the possibility of using data from a capnography device to assess obstructive airway severity in both COPD and Asthma patients. The study will include adult asthma and COPD patients (age >18). Patients will be enrolled on a continuous basis and will be monitored by capnograph and oximeter before and after lung function assessment and also during and after medical treatment.
- Keywords
- Asthma, Chronic Obstructive Pulmonary Disease (COPD), Capnography
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Asthma and COPD patients | Patients with COPD and Asthma. Continuous capnography and spirometry measurements of the subjects will be taken from the subjects with at least two minutes recording before the first spirometry assessment. All clinical diagnoses and treatments will be performed according to the department's protocols. This is an observational study with no interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between capnography parameters and severity of asthma
Correlation between the airway obstruction severity calculation based on the capnography parameters and the clinical severity of asthma and COPD as defined by forced expiratory volume in 1 second (FEV1), in severe asthma and COPD patients
Measured: 1/2 hour to 48 hours from enrollment of subjects
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study startNov 2016
- Primary completion21 May 2018
- Study completion21 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oridion
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Rabin Medical Center
- Responsible party
- Sponsor
- Investigators
- Mordechai M Kremer, Prof.; M.D, Principal investigator, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02805114
- Sponsor's protocol ID
- MDT17072
- Status last verified
- Jan 2019
- First submitted
- 15 Jun 2016
- Last updated
- 10 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Study publication will not contain any identifying data of individuals.
Publications
Pertzov B, Ronen M, Rosengarten D, Shitenberg D, Heching M, Shostak Y, Kramer MR. Use of capnography for prediction of obstruction severity in non-intubated COPD and asthma patients. Respir Res. 2021 May 21;22(1):154. doi: 10.1186/s12931-021-01747-3.
PubMed 34020637
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obstructive Airways Diseases in Pulmonary Clinic (OADPC) Study
- ClinicalTrials.gov ID
- NCT02805114
- Acronym / sponsor ID
- MDT17072
- Keywords
- Asthma, Chronic Obstructive Pulmonary Disease (COPD), Capnography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- OridionIndustry (pharma, biotech, devices)
- Collaborators
- Rabin Medical Center
- Study start
- Nov 2016 (actual)
- Primary completion
- 21 May 2018 (actual)
- Study completion
- 21 May 2018 (actual)
- First posted
- 17 Jun 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 an observational study which aims to evaluate the possibility of using data from a capnography device to assess obstructive airway severity in both Chronic Obstructive Pulmonary Disease (COPD) and Asthma patients.
Detailed description
This is an observational study which aims to evaluate the possibility of using data from a capnography device to assess obstructive airway severity in both COPD and Asthma patients. The study will include adult asthma and COPD patients (age >18). Patients will be enrolled on a continuous basis and will be monitored by capnograph and oximeter before and after lung function assessment and also during and after medical treatment.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Asthma and COPD patients | – | –Patients with COPD and Asthma. Continuous capnography and spirometry measurements of the subjects will be taken from the subjects with at least two minutes recording before the first spirometry assessment. All clinical diagnoses and treatments will be performed according to the department's protocols. This is an observational study with no interventions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Asthma and COPD patients
Key inclusion criteria (3 listed)
- Age >18
- Ability and willingness to participate the study and sign informed consent form
- Asthma / COPD patients
Key exclusion criteria (6 listed)
- Pregnant women
- Asthma or COPD patients with FEV1 > 80%
- Disability or unwillingness to undergo capnography measurement
- Cannot be assessed for FEV1
- Oxygen supply >5 L/min
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between capnography parameters and severity of asthma
Time frame: 1/2 hour to 48 hours from enrollment of subjects
Correlation between the airway obstruction severity calculation based on the capnography parameters and the clinical severity of asthma and COPD as defined by forced expiratory volume in 1 second (FEV1), in severe asthma and COPD patients
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 10 Jan 2019.
- Derived from this study: PubMed 34020637Pertzov B, Ronen M, Rosengarten D, Shitenberg D, Heching M, Shostak Y, Kramer MR. Use of capnography for prediction of obstruction severity in non-intubated COPD and asthma patients. Respir Res. 2021 May 21;22(1):154. doi: 10.1186/s12931-021-01747-3.
- Individual participant dataSharing planned: No. Study publication will not contain any identifying data of individuals.
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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.
Mordechai M Kremer, Prof.; M.D principal investigator
Rabin Medical Center
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 Asthma and Chronic Obstructive Pulmonary Disease (COPD), run by Oridion 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 3 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: finished, as of the sponsor's last update on 10 Jan 2019. 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?
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?
Correlation between capnography parameters and severity of asthma (time frame: 1/2 hour to 48 hours from enrollment of subjects). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02805114, which also lists 1 linked publication.
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 10 Jan 2019.