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NCT06346678 Clinical Trial

Accuracy of Accuhaler Tester, Ellipta Tester and Turbutester in Patients With Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:
Accuracy of Accuhaler Tester, Ellipta Tester and Turbutester in Patients With Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06346678
Other study ID # MTU-EC-IM-0-016/67
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 16, 2024
Est. completion date October 31, 2024

Study information
Verified date March 2024
Source Thammasat University
Contact Narongkorn Saiphoklang, MD
Phone +6629260794
Email M_narongkorn@hotmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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?

Description:

This study is a cross-sectional study. COPD patients aged 40 years or older will be included. Peak inspiratory flow rate (PIFR) will be assessed using In-check DIAL as the standard tool. PIFR will be tested in each patient using Accuhaler tester, Ellipta tester and Turbutester.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 80
Est. completion date October 31, 2024
Est. primary completion date August 31, 2024
Accepts healthy volunteers
Gender All
Age group 40 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Accuhaler tester
Patients will perform testing with Accuhaler tester, Ellipta tester and Turbutester.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Thammasat University

Outcome
Type Measure Description Time frame Safety issue
Primary Accuracy of Accuhaler tester Percentage At day 1 of the study
Primary Accuracy of Ellipta tester Percentage At day 1 of the study
Primary Accuracy of Turbutester Percentage At day 1 of the study
Secondary Prevalence of suboptimal peak inspiratory flow rate Percentage At day 1 of the study
Secondary Prevalence of insufficient peak inspiratory flow rate Percentage At day 1 of the study
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