Evaluation of Long-Acting Muscarinic Antagonists in COPD (MAN04)
Proof of Concept Evaluation of Drug-Device Interaction With Aclidinium Bromide Via Genuair® and Tiotropium Bromide Via HandiHaler® in COPD Using Impulse Oscillometry
In chronic obstructive pulmonary disease (COPD), the airways of the lungs are narrowed or blocked. Bronchodilators are drugs usually delivered through inhalers which help open up the airways. Tiotropium is a type of bronchodilator drug known as a long-acting muscarinic antagonist (LAMA). For a long time tiotropium was the only available LAMA. More recently, a new LAMA called aclidinium has been approved for use in COPD. There are potentially important differences between these two medications that might have an impact on the treatment of COPD patients.
In this study we aim to compare the effects of tiotropium and aclidinium in people with COPD. The main comparison will be done using a very sensitive breathing test called impulse oscillometry
연구 개요
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
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Dundee, 영국, DD1 9SY
- Asthma and Allergy Research Group, University of Dundee
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Male and female volunteers aged 40-80 years with moderate to severe COPD (GOLD Stage 2, 3).
- On inhaled corticosteroids / long-acting beta agonists
- FEV1 30-80% predicted and FEV1/FVC <70%.
- Smoking history ≥10 pack-years.
- Ability to give informed consent
- Agreement for their General Practitioner to be made aware of study participation and to receive feedback as relevant to the participant's well being
Exclusion Criteria:
- Other respiratory diseases such as asthma, bronchiectasis or allergic bronchopulmonary aspergillosis
- A COPD exacerbation or respiratory tract infection requiring systemic steroids and/or antibiotics within 1 month of the study commencement (3 months if hospitalisation has been required)
- Any clinically significant medical condition that may endanger the health or safety of the participant
- Known or suspected sensitivity to/intolerance of investigational medicinal product
- Patients with prostatic hyperplasia, bladder outflow obstruction or glaucoma
- Pregnancy or lactation
- Unable to comply with the procedures of the protocol
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Tiotropium
Participants receive tiotropium for 2 to 3 weeks.Participants then enter a washout period and after the washout period receive the alternative treatment arm.
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실험적: Aclidinium
Participants receive tiotropium for 2 to 3 weeks.Participants then enter a washout period and after the washout period receive the alternative treatment arm.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Change in trough R5 from baseline after chronic dosing
기간: 4 to 6 weeks
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4 to 6 weeks
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2차 결과 측정
결과 측정 |
기간 |
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Remaining impulse oscillometry (IOS) variables (R20,R5-R20,X5,AX,RF)
기간: 4 to 6 weeks
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4 to 6 weeks
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Spirometry (FEV1, FEF25-75, FVC)
기간: 4 to 6 weeks
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4 to 6 weeks
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Relaxed VC (RVC) with RVC to FVC ratio
기간: 4 to 6 weeks
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4 to 6 weeks
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Six-minute walk test (includes oxygen saturation measurements and Borg dyspnoea score)
기간: 4 to 6 weeks
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4 to 6 weeks
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Domiciliary PIKO-6 measurements for FEV1 and FEV6
기간: 4 to 6 weeks
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4 to 6 weeks
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St. George's Respiratory Questionnaire (SGRQ)
기간: 4 to 6 weeks
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4 to 6 weeks
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Baseline Dyspnea Index-Transition Dyspnea Index (BDI-TDI)
기간: 4 to 6 weeks
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4 to 6 weeks
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공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2013RC09
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