Clinical trial NCT04696965: Appropriate Inhaler Use of Tiotropium As Add-on Therapy in Symptomatic Asthma
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Tiotropium
Inhaler technique
Asthma
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2021-01-06
Enrollment: 48
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: PARALLEL
Intervention model description: Brief summary of protocol At visit 1, patients characteristics, lung function, cognition function, HRV, CRC and FeNo will be recorded. Randomization by stratification with cognition function will be done but both arms receive usual verbal instruction of inhaler steps.

At visit 2, inhaler step errors will be recorded 1 months after add-on Tiotropium with ICS+LABA and interventions of education start by correct/recheck strategy in study arm and usual verbal instruction in control arm.

At visit 3, inhaler step errors will be recorded 3 months after add-on Tiotropium with ICS+LABA as the primary endpoint. Heart rate variability (HRV), cardiopulmonary coupling (CRC) and FeNo will be checked.

Other endpoints, e.g. lung function, PEFR, exacerbation will be evaluated at V3 and V4 (6 months after V1), V5 (9 months after V1) and V6 (12month after V1)
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Errors rate of Inhaler steps
timeFrame: 3 months
Secondary outcomes:
measure: Asthma control
timeFrame: 3 months
measure: Asthma control
timeFrame: 3 months
measure: Forced expiratory volume in one second (FEV1) before bronchodilation
timeFrame: 3 months
measure: Acute exacerbation
timeFrame: 3, 6,9 and 12 month
Other outcomes:
measure: Correlation of the errors rate of Inhaler steps and mini-cog score
timeFrame: 1 month
measure: Correlation of the errors rate of Inhaler steps and poor asthma control
timeFrame: 3 month
Locations:
city: Taoyuan
country: Taiwan
facility: Department of Thoracic Medicine, Chang Gung Memorial Hospital
Study officials:
affiliation: Chest department, Chang-Gung Memorial Hospital, Linkou branch
name: Ting-Yu Lin
role: PRINCIPAL_INVESTIGATOR
References: