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

Risk of Re-Hospitalization in Patients With Chronic Obstructive Pulmonary Disease (COPD) Post Exacerbation

2017년 5월 19일 업데이트: GlaxoSmithKline

Differences in the Risk of Re-hospitalization and Other COPD-related (Chronic Obstructive Pulmonary Disease) Exacerbations and Costs for Patients Receiving Fluticasone Propionate-salmeterol Xinafoate Combination 250/50mcg (FSC) Versus Anticholinergics [i.e. Tiotropium (TIO) and Ipratropium or Combination Ipratropium-albuterol (IPR) Post-hospitalization or ED Visit for the Treatment of COPD.

This retrospective database study will assess differences in the risk of re-hospitalization and other COPD-related exacerbations and costs for patients receiving fluticasone propionate/salmeterol xinafoate combination 250/50 (FSC) versus anticholinergics [i.e. tiotropium (TIO) and ipratropium or combination ipratropium-albuterol (collectively referred to as ipratropium - IPR)] post-hospitalization or Emergency Department (ED) visit for the treatment of COPD.

This is a hypotheses testing study. Associations are compared between FSC and AC cohorts.

Hypotheses for the primary outcome and key secondary outcomes are presented below:

Specifically the study hypotheses for the primary outcome being tested were:

Ho: There is no difference in risk of COPD-related hospitalization between FSC and AC Ha: There is a difference in risk of COPD-related hospitalization between FSC and AC

Hypothesis for the key secondary outcome of COPD-related costs that was tested was:

Ho: There is no difference in COPD-related costs between FSC and AC Ha: There is a difference in COPD-related costs between FSC and AC

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

Managed care patients (aged >40 years) who were fluticasone propionate/salmeterol xinafoate combination (FSC)-naive in the 12 months pre-index period. The index-date was the date of discharge of the index Chronic Obstructive Pulmonary Disease (COPD)-related hospitalization/Emergency Department (ED) visit. Eligible patients were required to newly initiate or switch to drug therapy with FSC or ipratropium (IPR) / tiotropium (TIO) during the identification period (01/01/2004 to 01/31/2008) to treat COPD. Patients who switched to another maintenance medication or had an exacerbation in the treatment assessment period (30-days post-index date) were excluded from the study. Follow-up period was 12 months post treatment assessment period. Patients classified as being on FSC 250/50 versus anticholinergics (TIO, IP or IPR). Examined risk of COPD-related exacerbations such as hospitalizations, emergency department (ED) visits, COPD-related physician/outpatient visit with oral corticosteroid (OCS) or antibiotic prescription (ABX) within 5 days of physician/outpatient visit and COPD-related medical, pharmacy, and total healthcare costs in follow-up period.

연구 유형

관찰

등록 (실제)

1936

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

해당 없음

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

Managed care patients (aged >40 years) who were FSC naive in the 12 months pre-index period. The index-date was the date of discharge of the index COPD-related hospitalization/ED visit. Eligible patients were required to newly initiate or switch to drug therapy with FSC or IPR/TIO during the identification period (01/01/2004 to 01/31/2008) to treat COPD. Patients who switched to another maintenance medication or had an exacerbation in the treatment assessment period (30-days post-index date) were excluded from the study. Follow-up period was 12 months post treatment assessment period.

설명

Inclusion Criteria:

  • ≥40 years of age at index discharge date
  • Continuous health plan eligibility in the pre-index, treatment assessment, and follow-up periods
  • Absence of other fluticasone propionate -salmeterol xinafoate doses or combination product of budesonide-formoterol anytime during pre-index, treatment assessment, and follow-up periods

Exclusion Criteria:

  • COPD-related exacerbation during the treatment assessment period
  • Any therapy change, which was defined as switching or augmenting index therapy during treatment assessment period
  • Absence of comorbid conditions (respiratory cancer, cystic fibrosis, fibrosis due to tuberculosis, bronchiectasis, pneumonociosis, pulmonary fibrosis, pulmonary tuberculosis, and sarcoidosis) during the pre-index, treatment assessment, and follow-up periods

공부 계획

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

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
COPD patients receiving pharmacotherapy
COPD patients age 40 years and older receiving pharmacotherapy to treat their COPD and an index event of COPD hospitalization or ER visit.
의약품: FSC
fluticasone propionate / salmeterol xinofoate combination
다른 이름들:
  • Advair (tm)
의약품: ACs
tiotropium alone, ipratropium alone, or in combination with albuterol

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Risk of Hospitalization in COPD patients
기간: January 1, 2003 through March 31, 2009 (up to 6 years)
Risk of hospitalization was assessed as any hospitalization that was catpured in the follow up period. We required this event to have a primary discharge dx of COPD (ICD-9 code 491.xx, 492.xx, 496.xx) thus assuring it to be COPD-related. a logistic regression model was run to examine this outcome.
January 1, 2003 through March 31, 2009 (up to 6 years)

2차 결과 측정

결과 측정
측정값 설명
기간
Number of COPD exacerbations
기간: January 1, 2003 through March 31, 2009 (up to 6 years)
Exacerbation rates were assessed between the FSC and AC groups. We examined COPD-related (primary dx of COPD (ICD-9 code 491.xx, 492.xx, 496.xx)) emergency department visits, outpatient visits, outpatient visits accompanied by prescription of oral steroids and antibiotics. A negative binomial regression model was run to examine this outcome.
January 1, 2003 through March 31, 2009 (up to 6 years)
COPD-related Costs
기간: January 1, 2003 through March 31, 2009 (up to 6 years)
Mean COPD-related medical costs-, pharmacy costs - and total costs (the sum of medical and pharmacy costs) were calculated. Medical costs included healthcare facility and professional services charges for hospital admissions, ED visits, physician and other outpatient visits, and laboratory, radiology and other outpatient procedures with a primary diagnosis of COPD. Costs were adjusted to 2009 US dollars using the medical care component of the Consumer Price Index (CPI ). A Generalized Linear Model (GLM) with a log-link function was used to assess differences in costs.
January 1, 2003 through March 31, 2009 (up to 6 years)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

GlaxoSmithKline

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

2010년 9월 1일

기본 완료 (실제)

2010년 10월 1일

연구 완료 (실제)

2011년 3월 1일

연구 등록 날짜

최초 제출

2011년 6월 23일

QC 기준을 충족하는 최초 제출

2011년 6월 23일

처음 게시됨 (추정)

2011년 6월 27일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2017년 5월 22일

QC 기준을 충족하는 마지막 업데이트 제출

2017년 5월 19일

마지막으로 확인됨

2017년 5월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 113899

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. .

FSC에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Congo

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

3
구독하다