An observational study in Asthma, sponsored by Oridion. Completed at 1 site in Israel. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-02.
Sponsored by Oridion · Observational
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.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 73 is below the median of 150 across 970 observational studies indexed under Asthma.
Browse Asthma studies →Oridion is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Device: Capnostream20p
Device: Capnostream20p
The device will be used to monitor respiratory co2 values during the methacholine challenge, a well known diagnostic procedure
Measuring the change in expired CO2 over time in asthma patients during the methacholine challenge.
Time frame: 1 year
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
This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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