이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

DETECT-Register DocumEnTation and Evaluation of a COPD Combination Therapy (DETECT)

2018년 12월 10일 업데이트: AstraZeneca

Non-interventional Study for Documentation of the Therapeutic Efficacy, Use and Tolerance of the Fixed-Dose Combinations (FDC) Duaklir® Genuair® (Aclidinium/Formoterol), Ultibro® Breezhaler® (Glycopyrronium/Indacaterol) and Anoro® (Umeclidinium/Vilanterol) in the Treatment of COPD Under Real Conditions in the Practices of Pneumologists, Internists, and General Practitioners

Prospective, multi-centre, non-interventional study to collect findings about the effects of LABA/LAMA (Long Acting Beta2-Agonists / Long Acting Muscarinic Antagonists) combination preparations on COPD (Chronic obstructive pulmonary disease) symptoms and quality of life under real conditions and to find out what types of patients are selected for this therapy by physicians.

연구 개요

상태

완전한

정황

만성 폐쇄성 폐질환

상세 설명

Retrospective aspect of documentation: For patients who have already been changed over to a fixed-dose combination, lung function parameters and CAT (COPD Assessment Test™) score from the time prior to the changeover will be documented.

연구 유형

관찰

등록 (실제)

3732

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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  - Aachen, D6570r00001, 독일, D6570R00001
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  - Aldenhofen, D6570r00001, 독일, D6570R00001
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  - Celle, D6570r00001, 독일, D6570R00001
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  - Elterlein, D6570r00001, 독일, D6570R00001
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  - Essen, D6570r00001, 독일, D6570R00001
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  - Euerbach-Obbach, D6570r00001, 독일, D6570R00001
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  - Euskirchen, D6570r00001, 독일, D6570R00001
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  - Flensburg, D6570r00001, 독일, D6570R00001
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  - Frankfurt, D6570r00001, 독일, D6570R00001
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  - Frankfurt/M., D6570r00001, 독일, D6570R00001
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  - Freiberg, D6570r00001, 독일, D6570R00001
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  - Fuerstenwalde, D6570r00001, 독일, D6570R00001
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  - Fuerth, D6570r00001, 독일, D6570R00001
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  - Garching, D6570r00001, 독일, D6570R00001
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  - Leonberg, D6570r00001, 독일, D6570R00001
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  - Ludwigsburg-Ossweil, D6570r00001, 독일, D6570R00001
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  - Ludwigshafen, D6570r00001, 독일, D6570R00001
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  - Potsdam, D6570r00001, 독일, D6570R00001
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  - Thaleischweiler-Froeschen, D6570r00001, 독일, D6570R00001
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  - Weisswasser, D6570r00001, 독일, D6570R00001
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  - Wuppertal, D6570r00001, 독일, D6570R00001
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참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

40년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

샘플링 방법

확률 샘플

연구 인구

Patients who have been diagnosed with COPD (Chronic obstructive pulmonary disease), who have been changed over within the last 3 months to one of the 3 listed fixed-dose combinations (FDC) or for whom such a changeover is intended, and whose lung function parameters and CAT (COPD Assessment Test™) score from the time prior to the changeover are available (within the last 6 months) or are determined at the time of the 1st visit, if this is planned as part of the routine treatment.

설명

Inclusion Criteria:

Female/male of at least 40 years of age
Patient diagnosed with COPD
Patient was changed over within the last 3 months to a fixed-dose combination (FDC) (Aclidinium/Formeterol, Glycopyrronium/Indacaterol or Umeclidinium/Vilanterol), or there is already the intent to change the patient over to a fixed-dose combination (Aclidinium/Formeterol, Glycopyrronium/Indacaterol or Umeclidinium/Vilanterol).
Lung function parameters and CAT score from the time prior to the changeover to an FDC are on record (within the last 6 months in the case of patients who have already been changed over) or are determined at the 1st visit (in the case of patients who have not yet been changed over but for whom such a changeover is intended).
Signed declaration of consent

Exclusion Criteria:

The prescribing information for the fixed-dose combinations (Duaklir® Genuair®, Ulibtro® Breezhaler® or Anoro®) list contraindications for the patient.
Patient is pregnant, plans to become pregnant, or is nursing during the therapy period.
Patient suffers from hypersensitivity to one of the active ingredients of the fixed-dose combinations.
Patient is participating in a clinical trial.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

그룹/코호트 수

코호트 및 개입

그룹/코호트
Patients on Duaklir® Genuair® Patients on fixed-dose combination Duaklir® Genuair® (Aclidinium/Formoterol)
Patients on Ultibro® Breezhaler® Patients on fixed-dose combination Ultibro® Breezhaler® (Glycopyrronium/Indacaterol)
Patients on Anoro® Patients on fixed-dose combination Anoro® (Umeclidinium/Vilanterol)

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
Lung function 기간: First visit (baseline)	Assessment of FEV1 (Forced Expiratory Volume), FVC (Forced Vital Capacity)	First visit (baseline)
Number of patients with concomitant diseases classified by diagnostic subgroups 기간: First visit (baseline)		First visit (baseline)
Number of patients receiving concomitant COPD (Chronic obstructive pulmonary disease) medication classified by therapeutic subgroups 기간: First visit (baseline)		First visit (baseline)
Number of patients with exacerbations within the previous 24 months 기간: First visit (baseline)	History of previous exacerbations that will be collected at first observational visit.	First visit (baseline)

2차 결과 측정

결과 측정	측정값 설명	기간
Change in well-being and quality of life 기간: First visit (baseline) to end of observational period at 12 months	CAT (COPD Assessment Test™) questionnaire will be completed at each visit, approximately every 3 months.	First visit (baseline) to end of observational period at 12 months
Effect on the severity of the shortness of breath 기간: First visit (baseline) to end of observational period at 12 months	mMRC (modified Medical Research Council Dyspnea Scale) questionnaire will be completed at each visit, approximately every 3 months.	First visit (baseline) to end of observational period at 12 months
Change in the night-time and early-morning COPD symptoms 기간: First visit (baseline) to end of observational period at 12 months	NiSCI/EMSCI (Night-time symptoms of COPD Instrument / Early-morning symptoms of COPD instrument) questionnaire will be completed at each visit, approximately every 3 months.	First visit (baseline) to end of observational period at 12 months
Lung function 기간: First visit (baseline) to end of observational period at 12 months	Assessment of FEV1, FVC at each visit, approximately every 3 months.	First visit (baseline) to end of observational period at 12 months
Number of exacerbations by grade 기간: First visit (baseline) to end of observational period at 12 months	Number of exacerbations will be collected at each visit, approximately every 3 months	First visit (baseline) to end of observational period at 12 months
Adverse events 기간: First visit (baseline) to end of observational period at 12 months	Adverse events will be collected at each visit, approximately every 3 months.	First visit (baseline) to end of observational period at 12 months
Handling of inhaler 기간: At 12 months	Questionnaire regarding handling of inhaler by patient	At 12 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

AstraZeneca

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

유용한 링크

CSR Synopsis

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2015년 9월 24일

기본 완료 (실제)

2017년 12월 31일

연구 완료 (실제)

2017년 12월 31일

연구 등록 날짜

최초 제출

2015년 7월 29일

QC 기준을 충족하는 최초 제출

2015년 9월 16일

처음 게시됨 (추정)

2015년 9월 17일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2018년 12월 11일

QC 기준을 충족하는 마지막 업데이트 제출

2018년 12월 10일

마지막으로 확인됨

2018년 12월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

D6570R00001

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. .