Obstructive Airways Diseases in Pulmonary Clinic (OADPC) Study

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: May 21, 2018

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.

Arms, Groups and Cohorts

  • 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

Clinical Trial Outcome Measures

Primary Measures

  • 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

Participating in This Clinical Trial

Inclusion Criteria

1. Age >18

2. Ability and willingness to participate the study and sign informed consent form

3. Asthma / COPD patients

Exclusion Criteria

1. Pregnant women

2. Asthma or COPD patients with FEV1 > 80%

3. Disability or unwillingness to undergo capnography measurement

4. Cannot be assessed for FEV1

5. Oxygen supply >5 L/min

6. 6. Subjects that gone through LOBECTOMY OF LUNG in the last 5 years.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Oridion
  • Collaborator
    • Rabin Medical Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Mordechai M Kremer, Prof.; M.D, Principal Investigator, Rabin Medical Center

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