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NCT Number: NCT04696965

Appropriate Inhaler Use of Tiotropium As Add-on Therapy in Symptomatic Asthma

This pragmatic, two-arm, randomized controlled trial study aim to survey the inhaler errors of add-on tiotropium therapy with ICS+LABA in real-world practice of asthma patients and the efficacy of recheck stratage of inhaler skills. Patient characteristics and inflammatory features will be evaluated prospectively for association of asthma control by add-on tiotropium.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Thoracic Medicine, Chang Gung Memorial Hospital

Taoyuan, 33305, Taiwan

About this study

  • The clinical efficacy of tiotropium as add-on treatment to ICS with a LABA have been demonstrated in clinical trials in adult patients with symptomatic asthma.
  • Certain patients of daily care, like patients with smoking asthma, late onset asthma or asthma with chronic airway obstruction are often excluded from clinical trials.
  • Studies have shown the cognitive function of patients with COPD is impaired. When mixed types of inhaler devices are prescribed, the multiple steps of different devices may ensure complexity and confusion for patients, which may compromise the efficacy of add-on therapy. The inhaler error of add-on tiotropium treatment in real-world asthma treatment is unknown.
  • The improvement of step errors after varieties of teaching intervention is around 30~50%. Strategy of recheck inhaler technique recommended by the treatment guideline may optimized inhaler use. (https://ginasthma.org/gina-reports/).
  • Factors like responseness of short-acting bronchodilators and cholinergic tone have been reported as predictors of a positive clinical response of add-on tiotropium. However, more specific physiological or inflammatory factors. e.g. exhaled nitric oxide test (FeNo), and para symptomatic function and cardiac-pulmonary interaction have not been evaluated prospectively.
  • This pragmatic, two-arm, randomized controlled trial study aim to survey the inhaler errors of add-on tiotropium therapy with ICS+LABA in real-world practice of asthma patients and the efficacy of recheck stratage of inhaler skills. Patient characteristics and inflammatory features will be evaluated prospectively for association of asthma control by add-on tiotropium.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 20 to 75 years old asthmatic patients under regular treatment
  • Received medium to high dose ICS with LABA at least 3 months
  • Persistent asthma related symptoms: asthma control questionnaire (ACQ-7>1.5)
  • Physicians in charged prescribed Tiotropium as add-on therapy according to clinical judgement.

Exclusion criteria

  • Refuse to provide inform consent
  • Pregnancy or breastfeeding women
  • Patients with chronic obstructive pulmonary disease
  • Using other Long-acting Muscarinic Antagonists e.g. Sebree, Ultibro, Anoro and Spiolto

Treatment and study plan

Correct/recheck strategy

Other

One month after recruitment and every 3 months. 1. Check the inhaler step errors of patients by research assistant; 2.Demonstrate the right way by research assistant; 3. give the inhaler check list with marks of the wrong step(s) patients made to patients and 4. confirm the patients do the right way of the previous wrong step(s).

Usual verbal instruction

Other

One month after recruitment and every 3 months.1. Check the inhaler step errors of patients by research assistant; 2. Verbal instruction with a physical demonstration will be given by educational nurse in usual care.

Primary outcomes

  1. Errors rate of Inhaler steps

    Time frame: 3 months

    The improvement of inhaler steps errors after recheck stratage after 3 month of add-on tiotropium and ICS+LABA

Secondary outcomes

  1. Asthma control

    Time frame: 3 months

    The improvement of asthma control evaluated by Asthma Control Test (ACT). The scores range from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. An ACT score >19 indicates well-controlled asthma.

  2. Asthma control

    Time frame: 3 months

    The improvement of asthma control evaluated by Asthma Control Questionnaire-7 (ACQ-7).

    ACQ-7 is 7-point scale (0=no impairment, 6= maximum impairment for symptoms and rescue use; and 7 categories for FEV1%)

  3. Forced expiratory volume in one second (FEV1) before bronchodilation

    Time frame: 3 months

    The improvement of FEV1 before bronchodilation evaluated by spirometry after 3 month of add-on tiotropium and ICS+LABA

  4. Acute exacerbation

    Time frame: 3, 6,9 and 12 month

    The rate of acute exacerbation in one year

Other outcomes

  1. Correlation of the errors rate of Inhaler steps and mini-cog score

    Time frame: 1 month

    The mini-cog score will be evaluated when patient recruitment. The mini-cog is score of five-points in total, a score of zero, one or two indicates a concern in cognitive functioning.

    The error of inhaler steps will be recorded one month after 3 month of add-on tiotropium and ICS+LABA.

    Correlation will be tested via Pearson's test or Sperman rank correlation test.

  2. Correlation of the errors rate of Inhaler steps and poor asthma control

    Time frame: 3 month

    The error of inhaler steps will be recorded one month after add-on tiotropium therapy.

    Asthma control will be evaluated by Asthma Control Test (ACT) 3 months after 3 month of add-on tiotropium and ICS+LABA.

    Correlation will be tested via Pearson's test or Sperman rank correlation test. The distribution of errors rate of inhaler steps between patients with asthma well control (ACT>19) and patients with asthma poor control (ACT<=19) will be tested by Mann-Whitney test.

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

Appropriate Inhaler Use of Tiotropium As Add-on Therapy to Inhaled Glucocorticoids (ICS) with Long-acting Beta-agonists (LABA) in Adult Patients with Symptomatic Asthma: the Impact of Checking and Correcting Inhaler Technique in Real World

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 6, 2021
Registry last updated
Feb 28, 2025

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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