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Obstructive Airways Diseases in Pulmonary Clinic (OADPC) Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02805114
Recruitment Status : Completed
First Posted : June 17, 2016
Last Update Posted : January 10, 2019
Sponsor:
Collaborator:
Rabin Medical Center
Information provided by (Responsible Party):
Medtronic - MITG ( Oridion )

Brief 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.

Condition or disease
Asthma Chronic Obstructive Pulmonary Disease (COPD)

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.

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Obstructive Airways Diseases in Pulmonary Clinic (OADPC) Study
Actual Study Start Date : November 2016
Actual Primary Completion Date : May 21, 2018
Actual Study Completion Date : May 21, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Group/Cohort
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




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Asthma and COPD patients
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02805114


Locations
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Israel
Pulmonary Institute Rabin Medical center, Beilinson Hospital
Petach Tikva, Israel, 49100
Sponsors and Collaborators
Oridion
Rabin Medical Center
Investigators
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Principal Investigator: Mordechai M Kremer, Prof.; M.D Rabin Medical Center
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Responsible Party: Oridion
ClinicalTrials.gov Identifier: NCT02805114    
Other Study ID Numbers: MDT17072
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Study publication will not contain any identifying data of individuals.
Keywords provided by Medtronic - MITG ( Oridion ):
Asthma
Chronic Obstructive Pulmonary Disease (COPD)
Capnography
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases