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

COPD Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03275935
• Other study ID #: 73/17
• Status: Completed
• Phase: N/A
• First received: September 6, 2017
• Last updated: September 7, 2017
• Start date: March 1, 2017
• Est. completion date: June 30, 2017

Study information

• Verified date: September 2017
• Source: Kathmandu University School of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 307
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Asthma-COPD Overlap Syndrome
• COPD Asthma
• Inhalation
• Pulmonary Disease, Chronic Obstructive
• Respiratory Aspiration
• Syndrome

Locations

Country	Name	City	State
Nepal	Dhulikhel Hospital- Kathmandu University Hospital	Dhulikhel

Sponsors (1)

Lead Sponsor	Collaborator
Kathmandu University School of Medical Sciences

Country where clinical trial is conducted

Nepal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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