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

Completed

• Conditions: Chronic Obstructive Pulmonary Disease

• Registration Number: NCT06346678
• Lead Sponsor: Thammasat University

Brief 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?

Detailed 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.

Study Timeline

• Study First Submitted: 2024-03-29
• Study First Submitted QC: 2024-03-29
• Study Start: 2024-04-01
• Study First Posted: 2024-04-04
• Primary Completion: 2024-10-31
• Study Completion: 2024-11-15
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-16
• Last Update Posted: 2025-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Accuracy of Ellipta tester	At day 1 of the study	Percentage
Accuracy of Turbutester	At day 1 of the study	Percentage
Accuracy of Accuhaler tester	At day 1 of the study	Percentage

Secondary Outcome Measures

Name	Time	Method
Prevalence of insufficient peak inspiratory flow rate	At day 1 of the study	Percentage
Prevalence of suboptimal peak inspiratory flow rate	At day 1 of the study	Percentage

Trial Locations

Locations (1)

Narongkorn Saiphoklang; 🇹🇭 Klongluang, Pathumthani, Thailand