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

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 Overview

• Status: Unknown
• Conditions: Asthma
• Intervention / Treatment: Other: Correct/recheck strategy; Other: Usual verbal instruction

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 Type: Interventional
• Enrollment (Anticipated): 109
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taoyuan, Taiwan, 33305
    • Recruiting
    • Department of Thoracic Medicine, Chang Gung Memorial Hospital
    • Contact: Ting-Yu Lin, MD; Phone Number: 8157 886-3-3281200; Email: yuebaoyuebao@yahoo.com.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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).
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of the errors rate of Inhaler steps and mini-cog score	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.	1 month
Correlation of the errors rate of Inhaler steps and poor asthma control	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.	3 month

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Principal Investigator: Ting-Yu Lin, Chest department, Chang-Gung Memorial Hospital, Linkou branch

Study record dates

Study Major Dates

• Study Start (Anticipated): January 2, 2021
• Primary Completion (Anticipated): April 1, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: December 23, 2020
• First Submitted That Met QC Criteria: January 5, 2021
• First Posted (Actual): January 6, 2021

Study Record Updates

• Last Update Posted (Actual): January 12, 2021
• Last Update Submitted That Met QC Criteria: January 9, 2021
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Asthma; Tiotropium; Inhaler technique
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 202002047B0

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No