- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06346678
Accuracy of Accuhaler Tester, Ellipta Tester and Turbutester in Patients With Chronic Obstructive Pulmonary Disease
The goal of this observational study is to investigate the accuracy of Accuhaler tester, Ellipta tester and Turbutester in patients with chronic obstructive pulmonary disease (COPD). The main question it aims to answer is:
• Do Accuhaler tester, Ellipta tester, and Turbutester demonstrate comparable accuracy to the In-check DIAL for assessing inspiratory inhalation force in COPD patients?
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Changwat Pathum Thani
-
Pathum Thani, Changwat Pathum Thani, Thailand, 12120
- Narongkorn Saiphoklang
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- COPD diagnosis with confirmed by post-bronchodilator forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) <0.7
- Age 40 years or older
- Smoking history 10 pack-years or more
Exclusion Criteria:
- COPD exacerbation within 3 months
- Oral or intravenous corticosteroid treatment within 6 weeks
- Inability to perform assessment of peak inspiratory flow rate
- Asthma
- Tracheostomy, invasive or noninvasive mechanical ventilation
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Accuracy of Accuhaler tester
Time Frame: At day 1 of the study
|
Percentage
|
At day 1 of the study
|
|
Accuracy of Ellipta tester
Time Frame: At day 1 of the study
|
Percentage
|
At day 1 of the study
|
|
Accuracy of Turbutester
Time Frame: At day 1 of the study
|
Percentage
|
At day 1 of the study
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prevalence of suboptimal peak inspiratory flow rate
Time Frame: At day 1 of the study
|
Percentage
|
At day 1 of the study
|
|
Prevalence of insufficient peak inspiratory flow rate
Time Frame: At day 1 of the study
|
Percentage
|
At day 1 of the study
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Narongkorn Saiphoklang, MD, Thammasat University Faculty of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MTU-EC-IM-0-016/67
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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