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Completed

NCT Number: NCT03275935

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

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.

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Key information

Conditions

COPD Asthma Asthma Asthma-COPD Overlap Syndrome Asthma-Chronic Obstructive Pulmonary Disease Overlap Syndrome Bronchial Diseases Chronic Disease Disease Attributes Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Inhalation Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Aspiration Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dhulikhel Hospital- Kathmandu University Hospital

Dhulikhel, Nepal

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change in 'Inhalation Scores" After a month from Baseline

    Time frame: 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 outcomes

  1. Prevalance COPD, Asthma and Asthma COPD Overlap Syndrome inpatients visiting Chest Clinic of Dhulikhel Hospital- Kathmandu University Hospital.

    Time frame: 3 months

    Calculating the prevalence of the three medical conditions in Chest clinic of Dhulikhel Hospital

  2. Associated Factors for Incorrect Inhalation Technique

    Time frame: 3 months

    The potential associated factors for an incorrect inhalation technique to be calculated via univariable logistic regression analysis

  3. Prevalence of patients using the inhalation devices via incorrect technique

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Kathmandu University School of Medical Sciences

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Sep 8, 2017
Registry last updated
Sep 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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