- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02805114
Obstructive Airways Diseases in Pulmonary Clinic (OADPC) Study
January 9, 2019 updated by: Oridion
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 Overview
Status
Completed
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 Type
Observational
Enrollment (Actual)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Petach Tikva, Israel, 49100
- Pulmonary Institute Rabin Medical center, Beilinson Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Asthma and COPD patients
Description
Inclusion Criteria:
- Age >18
- Ability and willingness to participate the study and sign informed consent form
- Asthma / COPD patients
Exclusion Criteria:
- Pregnant women
- Asthma or COPD patients with FEV1 > 80%
- Disability or unwillingness to undergo capnography measurement
- Cannot be assessed for FEV1
- Oxygen supply >5 L/min
- 6. Subjects that gone through LOBECTOMY OF LUNG in the last 5 years.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
1/2 hour to 48 hours from enrollment of subjects
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Mordechai M Kremer, Prof.; M.D, Rabin Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2016
Primary Completion (Actual)
May 21, 2018
Study Completion (Actual)
May 21, 2018
Study Registration Dates
First Submitted
June 15, 2016
First Submitted That Met QC Criteria
June 16, 2016
First Posted (Estimate)
June 17, 2016
Study Record Updates
Last Update Posted (Actual)
January 10, 2019
Last Update Submitted That Met QC Criteria
January 9, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MDT17072
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Study publication will not contain any identifying data of individuals.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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