An Association Between Asthma Severity and Capnography Parameters

Asthma Clinical Trial

Official title:

An Association Between Asthma Severity and Capnography Parameters

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02296489
• Other study ID #: D007773
• Status: Completed
• Phase: N/A
• First received: November 4, 2014
• Last updated: November 1, 2016
• Start date: December 2014
• Est. completion date: June 2015

Study information

• Verified date: November 2016
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. The subject was invited to participate in methacholine challenge for the purposes of clinical assessment, with no relation to this study

2. Age 18-70

3. Ability to sign informed consent form

Exclusion Criteria:

1. Cannot or not willing to have capnography measurement during the entire methacholine challenge

2. Has or had in the past chronic obstructive pulmonary disease (COPD)

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Asthma

Intervention

Device:
• Capnostream20p
The device will be used to monitor respiratory co2 values during the methacholine challenge, a well known diagnostic procedure

Locations

Country	Name	City	State
Israel	Pulmonary Institute Rabin Medical center, Beilinson Hospital	Petach Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Oridion

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measuring the change in expired CO2 over time in asthma patients during the methacholine challenge.		1 year	No
Secondary	Finding a correlation between the change in expired CO2 and the severity of asthma as reflected by PC20.		1 year	No
Secondary	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).		1 year	No
Secondary	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.		1 year	No
Secondary	Finding a correlation between change in expired CO2 and fraction of exhaled nitric oxide (FeNO).		1 year	No