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

Not Applicable

Completed

• Conditions: Asthma
• Interventions: Other: Usual verbal instruction; Other: Correct/recheck strategy

• Registration Number: NCT04696965
• Lead Sponsor: Chang Gung Memorial Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2020-12-23
• Study First Submitted QC: 2021-01-05
• Study First Posted: 2021-01-06
• Study Start: 2021-03-04
• Primary Completion: 2023-03-13
• Study Completion: 2023-11-20
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual verbal instruction	Usual verbal instruction	Patients of control arm will be asked to show how thy use their two inhalers and identify errors using specific check list by research assistant. The educational nurse will give verbal instruction.
Correct/recheck strategy	Correct/recheck strategy	Patients of study arm will be asked to show how they use their two inhalers and identify errors using a device-specific checklist by research assistant. Research assistant then show the patient how to use these devices correctly and give the checklist including the steps patients did wrong. After teaching by the research assistant, patients were asked to demonstrate the correct way of wrong step(s) they made at beginning.

Primary Outcome Measures

Name	Time	Method
Errors rate of Inhaler steps	3 months	The improvement of inhaler steps errors after recheck stratage after 3 month of add-on tiotropium and ICS+LABA

Secondary Outcome Measures

Name	Time	Method
Acute exacerbation	3, 6,9 and 12 month	The rate of acute exacerbation in one year
Asthma control	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%)
Forced expiratory volume in one second (FEV1) before bronchodilation	3 months	The improvement of FEV1 before bronchodilation evaluated by spirometry after 3 month of add-on tiotropium and ICS+LABA

Trial Locations

Locations (1)

Department of Thoracic Medicine, Chang Gung Memorial Hospital; 🇨🇳 Taoyuan, Taiwan