AsthmaNCT02805127
Obstructive Airways Diseases in Emergency Department (OADED) Study
An observational study of Asthma and Chronic Obstructive Pulmonary Disease (COPD), run by Oridion.
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
- 12 participants
- Where
- No sites listed yet
- Study dates
- 22 Dec 2016to 6 Aug 2017
- 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 > 60%
- Disability or unwillingness to undergo capnography measurement
- Cannot be assessed for FEV1
- Oxygen supply >5 L/min
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 a feasibility 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 adults asthma and COPD patients (age >18) that arrive at the Emergency Department (ED). Patients will be enrolled on a continuous basis and will be monitored by a capnograph and an oximeter before, during and after lung function assessment and medical treatment.
- Keywords
- Asthma, 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 |
|---|---|---|
| Patients with COPD and Asthma . | Patients with COPD and Asthma. Continuous capnography and spirometry measurements of the subjects will be taken form 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 start22 Dec 2016
- Primary completion6 Aug 2017
- Study completion6 Aug 2017
Why it stopped: Lower recruitment rate than expected
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oridion
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hadassah Medical Organization
- Responsible party
- Sponsor
- Investigators
- Ruth Stalnikowicz, Prof. ; M.D., Principal investigator, Emergency Department, Hadassah University Hospital Mount Scopus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02805127
- Sponsor's protocol ID
- MDT17071
- Status last verified
- Dec 2017
- First submitted
- 15 Jun 2016
- Last updated
- 8 Dec 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 8 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obstructive Airways Diseases in Emergency Department (OADED) Study
- ClinicalTrials.gov ID
- NCT02805127
- Acronym / sponsor ID
- MDT17071
- Keywords
- Asthma, COPD, Capnography
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lower recruitment rate than expected
- Enrolment
- 12 participants (actual)
- Lead sponsor
- OridionIndustry (pharma, biotech, devices)
- Collaborators
- Hadassah Medical Organization
- Study start
- 22 Dec 2016
- Primary completion
- 6 Aug 2017 (actual)
- Study completion
- 6 Aug 2017 (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 a feasibility 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 adults asthma and COPD patients (age >18) that arrive at the Emergency Department (ED). Patients will be enrolled on a continuous basis and will be monitored by a capnograph and an oximeter before, during and after lung function assessment and medical treatment.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with COPD and Asthma . | – | –Patients with COPD and Asthma. Continuous capnography and spirometry measurements of the subjects will be taken form 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 (5 listed)
- Pregnant women
- Asthma or COPD patients with FEV1 > 60%
- 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 was stopped early (reason given: Lower recruitment rate than expected). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 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.
Ruth Stalnikowicz, Prof. ; M.D. principal investigator
Emergency Department, Hadassah University Hospital Mount Scopus
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Chronic Obstructive Pulmonary Disease (COPD), run by Oridion.
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 5 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: stopped early, as of the sponsor's last update on 8 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early (reason given: Lower recruitment rate than expected). 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?
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?
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 8 Dec 2017.