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

NCT06346678 | Completed

• 1 other identifier: MTU-EC-IM-0-016/67
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 1

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?

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic obstructive pulmonary disease; COPD; Accuhaler tester; Ellipta tester; Turbutester; Peak inspiratory flow rate

Outcome Measures

Primary Outcomes (3)

• Accuracy of Accuhaler tester

  Percentage

  At day 1 of the study

• Accuracy of Ellipta tester

  Percentage

  At day 1 of the study

• Accuracy of Turbutester

  Percentage

  At day 1 of the study

Secondary Outcomes (2)

• Prevalence of suboptimal peak inspiratory flow rate

  At day 1 of the study

• Prevalence of insufficient peak inspiratory flow rate

  At day 1 of the study

Interventions

Accuhaler tester OTHER

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

Also known as: Ellipta tester, Turbutester

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

COPD patients aged 40 years or older who are confirmed diagnosis by spirometry (post-bronchodilator FEV1/FVC \<0.7) and smoking history 10 pack-years or more.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Thammasat University: lead

Study Sites (1)

Narongkorn Saiphoklang

Pathum Thani, Changwat Pathum Thani, 12120, Thailand

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Narongkorn Saiphoklang, MD

  Thammasat University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: April 4, 2024
• Study Start: April 1, 2024
• Primary Completion: October 31, 2024
• Study Completion: November 15, 2024
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

TH (1)