NCT04696965

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

1. 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. 2. 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. 3. 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. 4. 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/). 5. 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. 6. 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.

Conditions

• Asthma

Interventions

Type	Name	Description
OTHER	Correct/recheck strategy	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).
OTHER	Usual verbal instruction	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.

Timeline

• Start date: 2021-03-04
• Primary completion: 2023-03-13
• Completion: 2023-11-20
• First posted: 2021-01-06
• Last updated: 2025-02-28

Locations

1 site across 1 country: Taiwan