AsthmaNCT04696965
Appropriate Inhaler Use of Tiotropium As Add-on Therapy in Symptomatic Asthma
A study testing Correct/recheck strategy and Usual verbal instruction in people with Asthma, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Asthma
- What is being tested?
- Correct/recheck strategy and Usual verbal instruction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTaiwan
- Study dates
- 4 Mar 2021to 20 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Thoracic Medicine, Chang Gung Memorial Hospital
Taoyuan, 33305
About this study
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
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.
Read the detailed description
- 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.
- 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.
- 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.
- 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/).
- 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.
- 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
- Being tested
- Correct/recheck strategy, Usual verbal instruction
- Keywords
- Tiotropium, Inhaler technique, Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Correct/recheck strategyOther
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 instructionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Usual verbal instruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Errors rate of Inhaler steps
The improvement of inhaler steps errors after recheck stratage after 3 month of add-on tiotropium and ICS+LABA
Measured: 3 months
Secondary outcomes (4)
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.
Measured: 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%)
Measured: 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
Measured: 3 months
Acute exacerbation
The rate of acute exacerbation in one year
Measured: 3, 6,9 and 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start4 Mar 2021
- Primary completion13 Mar 2023
- Study completion20 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- 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)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ting-Yu Lin, Chang Gung Memorial Hospital
- Investigators
- Ting-Yu Lin, Principal investigator, Chest department, Chang-Gung Memorial Hospital, Linkou branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04696965
- Sponsor's protocol ID
- 202002047B0
- Status last verified
- Feb 2025
- First submitted
- 23 Dec 2020
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04696965
- Acronym / sponsor ID
- 202002047B0
- Conditions
- Asthma
- Keywords
- Tiotropium, Inhaler technique, Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 4 Mar 2021 (actual)
- Primary completion
- 13 Mar 2023 (actual)
- Study completion
- 20 Nov 2023 (actual)
- First posted
- 6 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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.
- 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.
- 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/).
- 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.
- 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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| Correct/recheck strategy | Experimental | Other: Correct/recheck strategyPatients 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. |
| Usual verbal instruction | Active comparator | Other: Usual verbal instructionPatients 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. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Correct/recheck strategyOne 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). | Other | Correct/recheck strategy |
| Usual verbal instructionOne 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. | Other | Usual verbal instruction |
Primary outcome
Errors rate of Inhaler steps
Time frame: 3 months
The improvement of inhaler steps errors after recheck stratage after 3 month of add-on tiotropium and ICS+LABA
4 secondary outcomes
Asthma control
Time frame: 3 months
Asthma control
Time frame: 3 months
Forced expiratory volume in one second (FEV1) before bronchodilation
Time frame: 3 months
Acute exacerbation
Time frame: 3, 6,9 and 12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ting-Yu Lin principal investigator
Chest department, Chang-Gung Memorial Hospital, Linkou branch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Correct/recheck strategy and Usual verbal instruction in people with Asthma, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Errors rate of Inhaler steps (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.