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A Phase 2 Study to Determine the Safety and Efficacy of AIR001 in Subjects With Pulmonary Arterial Hypertension (PAH)

2014년 4월 7일 업데이트: Aires Pharmaceuticals, Inc.

A Phase 2, Multi-Center, Open-label, Randomized, Parallel-Dose Study to Determine the Safety and Efficacy of AIR001 in Subjects With WHO Group 1 Pulmonary Arterial Hypertension (PAH)

The purpose of this study is to evaluate the safety and effectiveness of an investigational/experimental drug called AIR001.

To test the effectiveness, the study will evaluate how AIR001 affects the blood vessels in the lungs and the function of the heart. This will be done by monitoring changes in Pulmonary Vascular Resistance (PVR); from Baseline/Day 1 (start of study drug) to Week 16 of the study. PVR measures the resistance to flow in the blood vessels of the lungs. The study will include other assessments to evaluate the effect of the study drug on PAH, including measurements of exercise ability and evaluations of PAH disease symptoms.

연구 개요

상태

종료됨

정황

개입 / 치료

상세 설명

The primary objective of this study is to evaluate the efficacy of inhaled nebulized AIR001 administered, for 16 weeks, according to 3 treatment arms (80 mg once daily, 46 mg 4 times daily, or 80 mg 4 times daily) in subjects with World Health Organization (WHO) Group 1 Pulmonary Arterial Hypertension (PAH), as determined by change in Pulmonary Vascular Resistance (PVR) from Baseline to Week 16 measured immediately post completion of AIR001 nebulization (as soon as feasible).

연구 유형

중재적

등록 (실제)

29

단계

  • 2 단계

연락처 및 위치

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

연구 장소

  • 미국
    • California
      • La Jolla, California, 미국, 92037
        • UCSD Medical Center
      • Torrance, California, 미국, 90509
        • UCLA Medical Center
    • Colorado
      • Aurora, Colorado, 미국, 80045
        • University of Colorado Denver
    • Kentucky
      • Louisville, Kentucky, 미국, 40202
        • Kentuckiana Pulmonary Associates
    • Maryland
      • Baltimore, Maryland, 미국, 21201
        • University of Maryland Medical Center
    • Massachusetts
      • Boston, Massachusetts, 미국, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, 미국, 02111
        • Tufts Medical Center
      • Boston, Massachusetts, 미국, 02118
        • Boston University School of Medicine
    • Missouri
      • St. Louis, Missouri, 미국, 63110-1093
        • Washington University School of Medicine
    • North Carolina
      • Durham, North Carolina, 미국, 27710
        • Duke University Medical Center
    • Ohio
      • Cincinnati, Ohio, 미국, 45267
        • University of Cincinnati
      • Columbus, Ohio, 미국, 43210
        • The Ohio State University Medical Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, 미국, 15213
        • University of Pittsburgh Medical Center
    • Texas
      • Dallas, Texas, 미국, 75390
        • University of Texas Southwestern Medical Center
      • Houston, Texas, 미국, 77030
        • Baylor College of Medicine
    • Virginia
      • Falls Church, Virginia, 미국, 22042
        • Inova Fairfax Hospital
    • Wisconsin
      • Milwaukee, Wisconsin, 미국, 53215
        • Aurora St. Luke's Medical Center
  • 헝가리
      • Budapest, 헝가리, 1083
        • Gottsegen Gyorgy Hungarian
      • Budapest, 헝가리, 1125
        • Semmelweis Karlocai
      • Debrecen, 헝가리, 4032
        • University of Debrecen
      • Szeged, 헝가리, 6720
        • University Of Szeged
  • 호주
    • New South Wales
      • Darlinghurst, New South Wales, 호주, 2010
        • St. Vincent's Hospital
    • Queensland
      • Chermside, Queensland, 호주, 4032
        • The Prince Charles Hospital
    • Tasmania
      • Hobart, Tasmania, 호주, 7000
        • Royal Hobart Hospital
    • Victoria
      • Melbourne, Victoria, 호주, 3004
        • The Alfred Hospital

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

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  1. Signed and dated informed consent document
  2. Able to comply with study procedures

  3. Diagnosis of PAH as classified by:

    1. Idiopathic (IPAH) or heritable(HPAH); or
    2. PAH associated with CTD; Systemic Sclerosis, Limited Scleroderma, Mixed, SLE, or overlap syndrome;
    3. PAH associated with HIV ii. Simple, congenital shunts at least one year post repair. iii. Exposure to legal drugs, chemicals and toxins

  4. Cardiac catheterization prior to Screening with:

    1. mPAP ≥ 25 mmHg (at rest);
    2. PCWP ≤ 15 mmHg; and
    3. PVR > 3 mmHg/L/min or 240 dyn.sec/cm5

  5. A qualification cardiac catheterization, to confirm the persistence and severity of PAH, if the diagnostic catheterization was performed more than 30 days prior to Baseline

    1. Confirms diagnosis;
    2. PVR above 300 dyn.sec/cm5 to demonstrate the persistence and severity of PAH; and
    3. No change in disease-specific PAH therapy since the qualification catheterization used
  6. Newly diagnosed PAH on no disease-specific PAH therapy or previously diagnosed on oral disease-specific PAH therapy for 90 days prior with either an ETRA and/or PDE-5i

  7. Has PFTs within 180 days prior to Baseline with no evidence of significant parenchymal lung disease defined as:

    • FEV1 ≤ 70% (predicted) (pre-bronchodilators);
    • FEV1/FVC ≤ 70% (pre-bronchodilators); or
    • Total lung capacity < 70% (predicted).
  8. Has WHO/NYHA FC II- IV.
  9. ≥ 18 and ≤ 75 years.
  10. Weight ≥ 40 kg.
  11. Has 6MWT distance at least 50 meters.
  12. Had a V/Q scan or pulmonary angiogram prior to Screening that shows no evidence of thromboembolic disease
  13. If on the following: vasodilators (including calcium channel blockers), digoxin, spironolactone, or L-Arginine; must be on a stable dose 30 days prior to Baseline and maintained throughout the study
  14. If on corticosteroids, has been receiving a stable dose of ≤ 20 mg/day of prednisone (or equivalent dose, if other corticosteroid) for at least 30 days
  15. Women of childbearing potential must be using at least one form of medically acceptable contraception. Women who are surgically sterile or those who are post-menopausal for at least 2 years are not considered to be of childbearing potential. Men who are not sterile must also agree to use contraception

Exclusion Criteria:

  1. Participation in a device or other interventional clinical studies, within 30 days of Baseline and during study participation
  2. Participation in a cardio-pulmonary rehabilitation program based upon exercise within 30 days prior to Baseline and/or during the study
  3. Has uncontrolled systemic hypertension: SBP > 160 millimeter of mercury (mmHg) or DBP > 100 mmHg during Screening
  4. SBP < 90 mmHg at Screening or Baseline
  5. History of orthostatic hypotension or at the time of Screening; defined as a drop in SBP by ≥ 20 mmHg or DBP of ≥ 10 mmHg during Screening

  6. History of left-sided heart disease and/or clinically significant cardiac disease, including:

    1. Aortic or mitral valve disease (stenosis or regurgitation) defined as greater than mild;
    2. Pericardial constriction;
    3. Restrictive or congestive cardiomyopathy;
    4. Left ventricular ejection fraction < 40%
    5. Left ventricular shortening fraction < 22% by ECHO prior to Screening;
    6. Symptomatic coronary disease
  7. Significant (2+ for regurgitation) valvular disease other than TR or PR
  8. Acutely decompensated heart failure within 30 days prior to Baseline
  9. History of atrial septostomy within 180 days prior to Baseline
  10. History of obstructive sleep apnea (treated, untreated or resolved)
  11. Diagnosis of Down syndrome
  12. Moderate to severe hepatic impairment
  13. Has chronic renal insufficiency as defined by serum creatinine > 2.5 mg/dL or has an eGFR < 30 mL/min at Screening, or requires dialysis
  14. Has a Hgb concentration < 8.5 g/dL at Screening

  15. Personal or family history of the following:

    1. Congenital or acquired methemoglobinemia;
    2. RBC CYPB5 reductase deficiency
  16. G6PD deficiency or any contraindication to receiving methylene blue

  17. For subjects with HIV any of the following:

    • Concomitant active opportunistic infections 180 days prior to Screening;
    • Detectable viral load within 90 days of Screening;
    • T-cell count < 200 mm3 within 90 days of Screening;
    • Changes in antiretroviral regimen within 90 days of Screening;
    • Using inhaled pentamidine
  18. Receiving chronic treatment with prostacyclin/prostacyclin analogue within 60 days of Baseline
  19. Requirement of intravenous inotropes within 30 days prior to Baseline
  20. The use of oral or topical nitrates (nitroglycerin, glyceryl trinitrate (GTN), isosorbide dinitrate, and isosorbide mononitrate) within 30 days prior to Baseline and until EOS or Termination
  21. Known or suspected hypersensitivity or allergic reaction to sodium nitrite or sodium nitrate
  22. History of malignancy within 5-years prior to Baseline
  23. Other severe acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation
  24. Has a disorder that compromises the ability to give informed consent
  25. Is currently pregnant or breastfeeding or intends to become pregnant
  26. Investigators, study staff or their immediate families

공부 계획

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

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 80mg AIR001 four times daily
80mg AIR001 nebulized four times daily for 16 weeks
의약품: AIR001 (sodium nitrite inhalation solution)
Dose arms specify dose loaded into the I-neb AAD System nebulizer
다른 이름들:
  • 아질산나트륨
  • nitrite
  • sodium nitrite inhalation solution
실험적: 46mg AIR001 four times daily
46mg AIR001 nebulized four times daily for 16 weeks
의약품: AIR001 (sodium nitrite inhalation solution)
Dose arms specify dose loaded into the I-neb AAD System nebulizer
다른 이름들:
  • 아질산나트륨
  • nitrite
  • sodium nitrite inhalation solution
실험적: 80mg AIR001 once daily
80mg AIR001 nebulized once daily for 16 weeks
의약품: AIR001 (sodium nitrite inhalation solution)
Dose arms specify dose loaded into the I-neb AAD System nebulizer
다른 이름들:
  • 아질산나트륨
  • nitrite
  • sodium nitrite inhalation solution

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in pulmonary vascular resistance (PVR)from baseline to week 16 assessed at peak AIR001
기간: 16 weeks
The primary objective of this study is to evaluate the efficacy of inhaled nebulized AIR001 administered, for 16 weeks, according to 3 treatment arms (80 mg once daily, 46 mg 4 times daily, or 80 mg 4 times daily) in subjects with World Health Organization (WHO) Group 1 Pulmonary Arterial Hypertension (PAH), as determined by change in Pulmonary Vascular Resistance (PVR) from Baseline to Week 16 measured immediately post completion of AIR001 nebulization (as soon as feasible).
16 weeks

2차 결과 측정

결과 측정
측정값 설명
기간
Time to Clinical Worsening (TTCW), other hemodynamics, and safety
기간: 16 weeks

To evaluate the effect of inhaled nebulized AIR001 administered according to 3 treatment arms (80 mg once daily, 46 mg 4 times daily, or 80 mg 4 times daily) in subjects with WHO Group 1 PAH for 16 weeks, as determined by time to the first morbidity/mortality event as defined in Time to Clinical Worsening (TTCW) assessments and change from Baseline to Week 16 in the following:

Pulmonary Vascular Resistance Index (PVRI), N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP), 6-Minute Walk Distance (6MWD) assessed at peak, 6MWD assessed prior to AIR001 nebulization (trough), Cardiac Output (CO), Cardiac Index (CI), Mean Right Atrial Pressure (mRAP), WHO/NYHA Functional Class (FC), Quality of Life (QOL) as measured by Short-Form 36 (SF-36), Borg Dyspnea Index, Mean pulmonary artery pressure (mPAP), PVR measured at trough, PVR/systemic vascular resistance (SVR) ratio at trough and peak,

To evaluate the safety and tolerability of AIR001 in subjects with WHO Group 1 PAH.
16 weeks

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Aires Pharmaceuticals, Inc.

수사관

  • 수석 연구원: Adaani E Frost, M.D., Baylor College of Medicine

간행물 및 유용한 링크

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

일반 간행물

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

2012년 11월 1일

기본 완료 (실제)

2014년 2월 1일

연구 완료 (실제)

2014년 2월 1일

연구 등록 날짜

최초 제출

2012년 11월 8일

QC 기준을 충족하는 최초 제출

2012년 11월 9일

처음 게시됨 (추정)

2012년 11월 12일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2014년 4월 9일

QC 기준을 충족하는 마지막 업데이트 제출

2014년 4월 7일

마지막으로 확인됨

2014년 4월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • AIR001-CS05

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. .

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