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

Evaluation of Inhalation Technique in Patients With Chronic Obstructive Pulmonary Disease (COPD), Asthma or Asthma-COPD Overlap Syndrome(ACOS) Using a Dry Powder Device at Chest Clinic in Dhulikhel Hospital

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 307

Contacts and Locations

Study Locations

• Nepal
  • Dhulikhel, Nepal
    • Dhulikhel Hospital- Kathmandu University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients presenting to Chest Clinic of Dhulikhel hospital, who were diagnosed of having either COPD, Asthma or Asthma-COPD Overlap Syndrome and are currently under inhalational bronchodilators in the form of Dry Powder Device (DPIs)

Description

Inclusion Criteria:

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

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Training Arm; Patients that were given training in regards to proper inhalation technique of Rotahalers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 'Inhalation Scores" After a month from Baseline	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	After a month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalance COPD, Asthma and Asthma COPD Overlap Syndrome inpatients visiting Chest Clinic of Dhulikhel Hospital- Kathmandu University Hospital.	Calculating the prevalence of the three medical conditions in Chest clinic of Dhulikhel Hospital	3 months
Associated Factors for Incorrect Inhalation Technique	The potential associated factors for an incorrect inhalation technique to be calculated via univariable logistic regression analysis	3 months
Prevalence of patients using the inhalation devices via incorrect technique	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.	At pretraining

Collaborators and Investigators

• Sponsor: Kathmandu University School of Medical Sciences
• Investigators: Principal Investigator: Dr Sudeep Shrestha, MD, MRCP(UK), Dhulikhel Hospital- Kathmandu University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2017
• Primary Completion (ACTUAL): June 30, 2017
• Study Completion (ACTUAL): June 30, 2017

Study Registration Dates

• First Submitted: September 6, 2017
• First Submitted That Met QC Criteria: September 6, 2017
• First Posted (ACTUAL): September 8, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 11, 2017
• Last Update Submitted That Met QC Criteria: September 7, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Asthma; COPD; ACOS; inhalation technique
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Immune System Diseases; Respiration Disorders; Lung Diseases; Hypersensitivity, Immediate; Disease; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Pulmonary Disease, Chronic Obstructive; Syndrome; Respiratory Aspiration; Asthma; Asthma-Chronic Obstructive Pulmonary Disease Overlap Syndrome
• Other Study ID Numbers: 73/17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No