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

NCT03275935 | Completed

• 1 other identifier: 73/17
• Study Type: observational
• Target: 307
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD Asthma; Asthma-COPD Overlap Syndrome; Inhalation

Keywords

ACOS; Asthma; COPD; inhalation technique

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  3 months

• Associated Factors for Incorrect Inhalation Technique

  3 months

• Prevalence of patients using the inhalation devices via incorrect technique

  At pretraining

Study Arms (1)

Training Arm

Patients that were given training in regards to proper inhalation technique of Rotahalers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kathmandu University School of Medical Sciences: lead

Study Sites (1)

Dhulikhel Hospital- Kathmandu University Hospital

Dhulikhel, Nepal

Location

MeSH Terms

Conditions

Asthma-Chronic Obstructive Pulmonary Disease Overlap Syndrome; Respiratory Aspiration; Asthma; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Hypersensitivity, Immediate

Study Officials

• Dr Sudeep Shrestha, MD, MRCP(UK)

  Dhulikhel Hospital- Kathmandu University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, CardioPulmonology Unit, Department of Internal Medicine

Study Record Dates

• First Submitted: September 6, 2017
• First Posted: September 8, 2017
• Study Start: March 1, 2017
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: September 11, 2017

Record last verified: 2017-09

Locations

NE (1)