Evaluation of Inhalation Technique in Patients With COPD, Asthma or ACOS Using a Dry Powder Device (DPI)

Completed

• Conditions: Asthma-COPD Overlap Syndrome; Inhalation; COPD Asthma

• Registration Number: NCT03275935
• Lead Sponsor: Kathmandu University School of Medical Sciences

Brief Summary

This study analyzes the prevalence of patients using inhalation devices via incorrect technique and access the adherence of patients to correct inhalation technique when taught along with their subjective improvement of symptoms.

Detailed Description

This is a one group pretest- posttest design conducted in all patients presenting in Chest clinic of Dhulikhel Hospital-Kathmandu University Hospital, Nepal from March 2017 to May 2017. Patients diagnosed of having COPD, Asthma or Asthma-COPD Overlap Syndrome (ACOS) and were under inhalation bronchodilators in the form of Dry Powder Device via Rotahaler were included. Enrolled patients are assessed for inhalation technique compliance at their routine medical (pre-training) visits by physician. The use of inhaler device is evaluated in a practical manner by asking the patients to demonstrate their inhalation technique. After the assessment, instructions and training are given until they can use the device correctly. One month later (post-training), all patients are re-evaluated in regards to inhalation technique and subjective improvement of symptoms.

Study Timeline

• Study Start: 2017-03-01
• Primary Completion: 2017-06-30
• Study Completion: 2017-06-30
• Status Verified: 2017-09
• Study First Submitted: 2017-09-06
• Study First Submitted QC: 2017-09-06
• Last Update Submitted: 2017-09-07
• Study First Posted: 2017-09-08
• Last Update Posted: 2017-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 307

Inclusion Criteria

• Age >18 years,
• Diagnosed of having of asthma or COPD or ACOS
• Using dry powder inhaler therapy with Rotahaler

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Exclusion Criteria

• Use of inhaler devices other than Rotahaler
• Newly started on dry powdered inhalational therapy or patients who had recently received face-to-face training program on inhalation technique within the past one month
• Patients in acute exacerbation
• Patients failing to give consent

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in 'Inhalation Scores" After a month from Baseline	After a month	An observation checklist measuring essential steps required for adequate drug delivery for Rotahaler was developed. The number of required steps are seven and the correctness of the seven-step inhalation technique was measured by giving a score 0 for incorrect action and 1 for correct action. Each of the seven steps were scored 1 or 0, giving a total score of 0-7. After assessment, instructions were given with demonstrations regarding the correct use of Rotahaler. One month later (post-training visit), all patients were re-evaluated

Secondary Outcome Measures

Name	Time	Method
Prevalance COPD, Asthma and Asthma COPD Overlap Syndrome inpatients visiting Chest Clinic of Dhulikhel Hospital- Kathmandu University Hospital.	3 months	Calculating the prevalence of the three medical conditions in Chest clinic of Dhulikhel Hospital
Associated Factors for Incorrect Inhalation Technique	3 months	The potential associated factors for an incorrect inhalation technique to be calculated via univariable logistic regression analysis
Prevalence of patients using the inhalation devices via incorrect technique	At pretraining	An observation checklist measuring essential steps required for adequate drug delivery for Rotahaler was developed. The number of required steps are seven and the correctness of the seven-step inhalation technique was measured by giving a score 0 for incorrect action and 1 for correct action. Each of the seven steps were scored 1 or 0, giving a total score of 0-7.

Trial Locations

Locations (1)

Dhulikhel Hospital- Kathmandu University Hospital; 🇳🇵 Dhulikhel, Nepal