Appropriate Inhaler Use of Tiotropium as add-on Therapy in Symptomatic Asthma

Asthma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04696965
• Other study ID #: 202002047B0
• Status: Recruiting
• Phase: N/A
• Start date: January 2, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: December 2020
• Source: Chang Gung Memorial Hospital
• Contact: Ting-Yu Lin
• Phone: 886-3-3281200
• Email: h12519[@]cgmh.org.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 109
• Est. completion date: December 31, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

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).
• 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.

Locations

Country	Name	City	State
Taiwan	Department of Thoracic Medicine, Chang Gung Memorial Hospital	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Acute exacerbation	The rate of acute exacerbation in one year	3, 6,9 and 12 month