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Completed

NCT Number: NCT04999930

Tiotropium Respimat Administration With and Without Aerochamber Disease (COPD)

COPD patient on Tiotropium Respimart divided into two group, Group A given aerochamber and Group B without aerochamber enroll in the study for total 18 week .

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National University of Malaysia

Cheras, Kuala Lumpur, 50600, Malaysia

About this study

  • COPD patient who is on Tiotropium Respimart and other inhalers continued.
  • Those fullfill inclusion criteria will be randomized into two group.
  • To do Baseline CAT score and SGRQ questionnaires with Lung function test.
  • Assess inhaler technique with and without aerochamber.
  • Teach proper inhaler technique by templates and demonstrate to patients.
  • Group A given aerochamber and Group B without aerochamber enroll in the study for total 18 week .
  • First phase for 8 week after that 2 week of washout periode (without aerochamber both arm).
  • Then Group A without aerochamber and Group B with aerochamber continue with all inhalers for 8 week.
  • Followed up at 8th , 11th and 18th week to assess inhaler techniques ,Lung function test and do CAT score, and SGRQ questionnaire.
  • Analysis data

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • COPD patients under Respiratory clinic UKM follow up
  • Patients who are with stable COPD (no exacerbation past 2 months)
  • Age same and more than 40-year-old
  • Patient able to perform inhaler medication
  • Patient able to perform technically acceptable pulmonary function test

Exclusion criteria

  • Drug hypersensitivity
  • Bronchial Asthma
  • Significant disease that may influence patient's ability to participate in the study.
  • Unable to provide signed informed consent
  • Mental condition rendering the subject unable to understand the nature, scope and the possible consequences of the study.

Treatment and study plan

Aerochamber

Device

efficacy and patients satisfaction

Other names: Tiotropium respimart

Primary outcomes

  1. To compare the frequency of exacerbation (number of events ) and hospital admission (number of admissions) using tiotropium with and without aerochamber

    Time frame: 18 weeks

    Comparing frequency of exacerbation (number of events ) and hospital admission (number of admissions) in both groups

Secondary outcomes

  1. Change of FEV1 (%) between the treatment group

    Time frame: 18 weeks

    Comparing differences of lung function (FEV1 %) in both groups after cross-over

  2. Types of inhaler technique error between the group

    Time frame: 18 weeks

    Comparing inhaler errors in both groups based on the checklist

  3. To assess quality of life (SGRQ questionaire)

    Time frame: 18 weeks

    Scores range from 0 to 100, with higher scores indicating more limitations.

  4. To assess patients satisfaction and preference, attitudes, and perceptions about their inhalers using questionnaire

    Time frame: 18 weeks

    Scale of 0-5, (0-very easy, 5-hard)

Sponsors and collaborators

Lead sponsor

National University of Malaysia

Other

Registry information

Official study title

Comparison of Clinical Efficacy and Patient's Satisfaction of Tiotropium Respimat Administration With and Without Aerochamber in Patient With Chronic Obstructive Pulmonary Disease (COPD)

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 11, 2021
Registry last updated
Aug 18, 2021

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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