AsthmaNCT02296489
An Association Between Asthma Severity and Capnography Parameters
An observational study of Asthma, run by Oridion at 1 site in Israel.
Trial summary
Asthma is a common chronic disorder of the airways characterized by periods of reversible airflow obstruction known as asthma episodes or attacks. Asthma attacks are caused by chronically hyperactive (contraction of the muscles surrounding the airways) and inflamed airways, leading to airflow obstruction, and may be… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Capnostream20p
- Type of treatment
- Medical device
- How many people
- 73 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2014to Jun 2015
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Sixty subjects, both men and women, who will be invited to participate in the methacholine challenge in the Institute of Pulmonary Medicine at Rabin Medical Center, regardless to the study, will be recruitment to the study.
Who may be able to join
- The subject was invited to participate in methacholine challenge for the purposes of clinical assessment, with no relation to this study
- Age 18-70
- Ability to sign informed consent form
Who cannot join
- Cannot or not willing to have capnography measurement during the entire methacholine challenge
- Has or had in the past chronic obstructive pulmonary disease (COPD)
Trial locations and contacts
1 site in 1 country.
Israel1 site
Pulmonary Institute Rabin Medical center, Beilinson Hospital
Petah Tikva, 49100
About this study
Asthma is a common chronic disorder of the airways characterized by periods of reversible airflow obstruction known as asthma episodes or attacks. Asthma attacks are caused by chronically hyperactive (contraction of the muscles surrounding the airways) and inflamed airways, leading to airflow obstruction, and may be mild, moderate, or severe enough to become life-threatening events. Severity of asthma exacerbation is assessed through medical history and lung function measurements with Spirometer and requires full cooperation of the patient. Thus, in uncooperative populations or during emergency medical situations the spirometer cannot be used. As an alternative, capnography data has been proposed as an indicator of bronchospasm in asthma. Previous studies found correlations between the capnography parameters and methacholine challenge in asthma patients. However, the relationship between capnography parameters and severity of asthma or severity of asthma exacerbation have not been well characterized. The study hypothesis is that within the clinical population that is invited to do the methacholine challenge, a different waveform pattern in asthma patients will be detected and possibly a correlation between the severity of obstruction and pattern of waveform during the methacholine challenge. In this proposed feasibility observational study, sixty subjects, both men and women, who will be invited to participate in the methacholine challenge in the Institute of Pulmonary Medicine at Rabin Medical Center, will be recruited to the study. Respiratory information will be recorded using the CapnostreamTM20p while the subjects will wear the non-invasive Smart CapnoLine® Plus sampling line. Additionally, FeNO will be measured using a DENOX 88 device during the methacholine challenge.
- Conditions
- Asthma
- Being tested
- Capnostream20p
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capnostream20pDevice
The device will be used to monitor respiratory co2 values during the methacholine challenge, a well known diagnostic procedure
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Not described Receives: Device: Capnostream20p | |
| Asthma patients | Not described Receives: Device: Capnostream20p |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring the change in expired CO2 over time in asthma patients during the methacholine challenge.
Measured: 1 year
Secondary outcomes (4)
Finding a correlation between the change in expired CO2 and the severity of asthma as reflected by PC20.
Measured: 1 year
Finding a correlation between the change in expired CO2 and the severity of asthma as reflected by the frequency of symptoms according the Asthma Severity Tool (AST).
Measured: 1 year
Finding correlations between changes in capnography parameters and the severity of asthma as reflected by preliminary FEV1, forced vital capacity (FVC), FEV1/FVC, and peak expiratory flow rate.
Measured: 1 year
Finding a correlation between change in expired CO2 and fraction of exhaled nitric oxide (FeNO).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study startDec 2014
- Primary completionJun 2015
- Study completionJun 2015
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-control
- Time perspective
- Prospective
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oridion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02296489
- Sponsor's protocol ID
- D007773
- Status last verified
- Nov 2016
- First submitted
- 4 Nov 2014
- Last updated
- 2 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Association Between Asthma Severity and Capnography Parameters
- ClinicalTrials.gov ID
- NCT02296489
- Acronym / sponsor ID
- D007773
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- OridionIndustry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 20 Nov 2014 (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.
Asthma is a common chronic disorder of the airways characterized by periods of reversible airflow obstruction known as asthma episodes or attacks. Asthma attacks are caused by chronically hyperactive (contraction of the muscles surrounding the airways) and inflamed airways, leading to airflow obstruction, and may be mild, moderate, or severe enough to become life-threatening events. Severity of asthma exacerbation is assessed through medical history and lung function measurements with Spirometer and requires full cooperation of the patient. Thus, in uncooperative populations or during emergency medical situations the spirometer cannot be used. As an alternative, capnography data has been proposed as an indicator of bronchospasm in asthma. Previous studies found correlations between the capnography parameters and methacholine challenge in asthma patients. However, the relationship between capnography parameters and severity of asthma or severity of asthma exacerbation have not been well characterized. The study hypothesis is that within the clinical population that is invited to do the methacholine challenge, a different waveform pattern in asthma patients will be detected and possibly a correlation between the severity of obstruction and pattern of waveform during the methacholine challenge. In this proposed feasibility observational study, sixty subjects, both men and women, who will be invited to participate in the methacholine challenge in the Institute of Pulmonary Medicine at Rabin Medical Center, will be recruited to the study. Respiratory information will be recorded using the CapnostreamTM20p while the subjects will wear the non-invasive Smart CapnoLine® Plus sampling line. Additionally, FeNO will be measured using a DENOX 88 device during the methacholine challenge.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | Device: Capnostream20p |
| Asthma patients | – | Device: Capnostream20p |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Sixty subjects, both men and women, who will be invited to participate in the methacholine challenge in the Institute of Pulmonary Medicine at Rabin Medical Center, regardless to the study, will be recruitment to the study.
Key inclusion criteria (3 listed)
- The subject was invited to participate in methacholine challenge for the purposes of clinical assessment, with no relation to this study
- Age 18-70
- Ability to sign informed consent form
Key exclusion criteria (2 listed)
- Cannot or not willing to have capnography measurement during the entire methacholine challenge
- Has or had in the past chronic obstructive pulmonary disease (COPD)
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 |
|---|---|---|
| Capnostream20pThe device will be used to monitor respiratory co2 values during the methacholine challenge, a well known diagnostic procedure | Device | Asthma patients, Healthy volunteers |
Primary outcome
Measuring the change in expired CO2 over time in asthma patients during the methacholine challenge.
Time frame: 1 year
4 secondary outcomes
Finding a correlation between the change in expired CO2 and the severity of asthma as reflected by PC20.
Time frame: 1 year
Finding a correlation between the change in expired CO2 and the severity of asthma as reflected by the frequency of symptoms according the Asthma Severity Tool (AST).
Time frame: 1 year
Finding correlations between changes in capnography parameters and the severity of asthma as reflected by preliminary FEV1, forced vital capacity (FVC), FEV1/FVC, and peak expiratory flow rate.
Time frame: 1 year
Finding a correlation between change in expired CO2 and fraction of exhaled nitric oxide (FeNO).
Time frame: 1 year
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 2 Nov 2016.
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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 Asthma, 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 2 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 2 Nov 2016. 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?
Measuring the change in expired CO2 over time in asthma patients during the methacholine challenge. (time frame: 1 year). 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 2 Nov 2016; AzTrials last refreshed its copy on 30 Oct 2026.