Obstructive Airways Diseases in Pulmonary Clinic (OADPC) Study

Completed

• Conditions: Chronic Obstructive Pulmonary Disease (COPD); Asthma

• Registration Number: NCT02805114
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2016-06-15
• Study First Submitted QC: 2016-06-16
• Study First Posted: 2016-06-17
• Study Start: 2016-11
• Primary Completion: 2018-05-21
• Study Completion: 2018-05-21
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-09
• Last Update Posted: 2019-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between capnography parameters and severity of asthma	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

Trial Locations

Locations (1)

Pulmonary Institute Rabin Medical center, Beilinson Hospital; 🇮🇱 Petach Tikva, Israel