- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04696965
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
연구 개요
상세 설명
- 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.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Taoyuan, 대만, 33305
- 모병
- Department of Thoracic Medicine, Chang Gung Memorial Hospital
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연락하다:
- Ting-Yu Lin, MD
- 전화번호: 8157 886-3-3281200
- 이메일: yuebaoyuebao@yahoo.com.tw
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
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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).
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활성 비교기: 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.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Errors rate of Inhaler steps
기간: 3 months
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The improvement of inhaler steps errors after recheck stratage after 3 month of add-on tiotropium and ICS+LABA
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3 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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천식 조절
기간: 3 개월
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천식 조절 테스트(ACT)에 의해 평가된 천식 조절의 개선.
점수의 범위는 5(천식 조절 불량)에서 25(천식 완전 조절)까지이며, 점수가 높을수록 천식이 더 잘 조절되었음을 나타냅니다.
ACT 점수 >19는 잘 조절된 천식을 나타냅니다.
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3 개월
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Asthma control
기간: 3 months
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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
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Forced expiratory volume in one second (FEV1) before bronchodilation
기간: 3 months
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The improvement of FEV1 before bronchodilation evaluated by spirometry after 3 month of add-on tiotropium and ICS+LABA
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3 months
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Acute exacerbation
기간: 3, 6,9 and 12 month
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The rate of acute exacerbation in one year
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3, 6,9 and 12 month
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Correlation of the errors rate of Inhaler steps and mini-cog score
기간: 1 month
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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
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Correlation of the errors rate of Inhaler steps and poor asthma control
기간: 3 month
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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
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공동 작업자 및 조사자
수사관
- 수석 연구원: Ting-Yu Lin, Chest department, Chang-Gung Memorial Hospital, Linkou branch
연구 기록 날짜
연구 주요 날짜
연구 시작 (예상)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Correct/recheck strategy에 대한 임상 시험
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Manhattan Beach Orthodontics완전한