Obstructive Airways Diseases in Pulmonary Clinic (OADPC) Study

Asthma Clinical Trial

Official title:

Obstructive Airways Diseases in Pulmonary Clinic (OADPC) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02805114
• Other study ID #: MDT17072
• Status: Completed
• Start date: November 2016
• Est. completion date: May 21, 2018

Study information

• Verified date: January 2019
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 21, 2018
• Est. primary completion date: May 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Oridion	Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between capnography parameters and severity of asthma	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	1/2 hour to 48 hours from enrollment of subjects