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

NCT04696965 | Completed

• 1 other identifier: 202002047B0
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

Tiotropium; Inhaler technique; Asthma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Asthma control

  3 months

• Asthma control

  3 months

• Forced expiratory volume in one second (FEV1) before bronchodilation

  3 months

• Acute exacerbation

  3, 6,9 and 12 month

Other Outcomes (2)

• Correlation of the errors rate of Inhaler steps and mini-cog score

  1 month

• Correlation of the errors rate of Inhaler steps and poor asthma control

  3 month

Study Arms (2)

Correct/recheck strategy

EXPERIMENTAL

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

Usual verbal instruction

ACTIVE COMPARATOR

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

Interventions

Correct/recheck strategy OTHER

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).

Correct/recheck strategy

Usual verbal instruction OTHER

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.

Usual verbal instruction

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Department of Thoracic Medicine, Chang Gung Memorial Hospital

Taoyuan District, 33305, Taiwan

Location

MeSH Terms

Conditions

Asthma

Interventions

docusate sodium mixt. with phenolphtalein

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Ting-Yu Lin

  Chest department, Chang-Gung Memorial Hospital, Linkou branch

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The subjects enrolled will be informed the purpose of this study is to evaluate the inhaler step errors after add-on tiotropium with the other ICS+LABA inhaler and how the education improve patients to reduce the error rate. The subjects are not aware the different methods of study arm and control arm.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician

Model Details: 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)

Study Record Dates

• First Submitted: December 23, 2020
• First Posted: January 6, 2021
• Study Start: March 4, 2021
• Primary Completion: March 13, 2023
• Study Completion: November 20, 2023
• Last Updated: February 28, 2025

Record last verified: 2025-02

Locations

TW (1)