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

Trial Comparing the Safety and Efficacy of Two Different Oral VPV Doses With Placebo as Treatment for RV in Participants With COPD (Cardinal COPD)

2026년 10월 21일 업데이트: Altesa Biosciences, Inc.

A Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial Comparing the Safety and Efficacy of Two Different Oral Vapendavir (VPV) Doses With Placebo as Treatment for Rhinovirus (RV) in Participants With Chronic Obstructive Pulmonary Disease (COPD)

Compare the safety and efficacy of two different oral vapendavir doses with placebo in order to determine the appropriate dose of vapendavir to reduce the severity and/or duration of respiratory symptoms associated with RV infections in patients with COPD.

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

180

단계

  • 2 단계

연락처 및 위치

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

연구 연락처

연구 장소

  • 미국
    • Alabama
      • Mobile, Alabama, 미국, 36608
        • 모병
        • Velocity Clinical Research - Mobile
        • 연락하다:
          • Velocity Clinical Research - Mobile
    • Arizona
      • Tempe, Arizona, 미국, 85281
        • 모집하지 않고 적극적으로
        • AMR Clinical - Tempe
    • California
      • Inglewood, California, 미국, 90301
        • 모집하지 않고 적극적으로
        • 310 Clinical Research, LLC
      • Newport Beach, California, 미국, 92663
        • 모병
        • NewportNativeMD, Inc.
        • 연락하다:
          • NewportNativeMD, Inc.
      • San Diego, California, 미국, 92120
        • 모병
        • Apex Clinical Research
        • 연락하다:
          • Apex Clinical Research
    • Florida
      • Bradenton, Florida, 미국, 34209
        • 모병
        • Synergy Health
        • 연락하다:
          • Synergy Health
      • Miami Lakes, Florida, 미국, 33014
        • 모병
        • VM Clintrials
        • 연락하다:
          • VM Clintrials
      • Miami Lakes, Florida, 미국, 33016
        • 모병
        • Medquest Translational Sciences
        • 연락하다:
          • Medquest Translational Sciences
      • Tamarac, Florida, 미국, 33321
        • 모병
        • Metropolitan Clinical Research Center
        • 연락하다:
          • Metropolitan Clinical Research Center
    • Georgia
      • East Point, Georgia, 미국, 30344
        • 모병
        • Covenant Critical Pulmonary Care
        • 연락하다:
          • Covenant Critical Pulmonary Care
      • Snellville, Georgia, 미국, 30078
        • 모집하지 않고 적극적으로
        • Accelerated Clinical Trials
    • Illinois
      • Naperville, Illinois, 미국, 60540
        • 모병
        • Bioluminux Clinical Research Illinois
        • 연락하다:
          • Bioluminux Clinical Research Illinois
    • Indiana
      • Valparaiso, Indiana, 미국, 46383
        • 모병
        • Velocity Clinical Research - Valparaiso
        • 연락하다:
          • Velocity Clinical Research - Valparaiso
    • Kentucky
      • Lexington, Kentucky, 미국, 40509
        • 모집하지 않고 적극적으로
        • AMR Clinical - Lexington
    • Maryland
      • Lutherville, Maryland, 미국, 21093
        • 모병
        • Patient First Clinical Trials (PFCTRIALS)
        • 연락하다:
          • Patient First Clinical Trials (PFCTRIALS)
    • Michigan
      • Dearborn, Michigan, 미국, 48126
        • 모병
        • Verexa Health
        • 연락하다:
          • Verexa Health
      • Troy, Michigan, 미국, 48085
        • 모병
        • Oakland Medical Research
        • 연락하다:
          • Oakland Medical Research
    • Nevada
      • Las Vegas, Nevada, 미국, 89119
        • 모집하지 않고 적극적으로
        • AMR Clinical - Las Vegas
    • New Jersey
      • Hamilton, New Jersey, 미국, 08690
        • 모병
        • Bioluminux Clinical Research New Jersey
        • 연락하다:
          • Bioluminux Clinical Research New Jersey
    • New York
      • Binghamton, New York, 미국, 13905
        • 모병
        • Velocity Clinical Research - Binghamton
        • 연락하다:
          • Velocity Clinical Research - Binghamton
      • Brooklyn, New York, 미국, 11226
        • 모병
        • Brooklyn Clinical Research
        • 연락하다:
          • Brooklyn Clinical Research
    • North Carolina
      • Kings Mountain, North Carolina, 미국, 28086
        • 모병
        • CRC Kings Mountain
        • 연락하다:
          • CRC Kings Mountain
    • Ohio
      • Columbus, Ohio, 미국, 43215
        • 모병
        • Remington-Davis, Inc.
        • 연락하다:
          • Remington-Davis, Inc.
      • Milford, Ohio, 미국, 45150
        • 모병
        • Hometown Urgent Care - Milford
        • 연락하다:
          • Hometown Urgent Care - Milford
    • Oklahoma
      • Edmond, Oklahoma, 미국, 73013
        • 모병
        • Tekton Research
        • 연락하다:
          • Tekton Research
    • Oregon
      • Medford, Oregon, 미국, 97504
        • 모병
        • Velocity Clinical Research - Medford
        • 연락하다:
          • Velocity Clinical Research - Medford
    • Pennsylvania
      • DuBois, Pennsylvania, 미국, 15801
        • 모병
        • Clinical Research Associates of Central PA, LLC
        • 연락하다:
          • Clinical Research Associates of Central PA, LLC l
      • Pittsburgh, Pennsylvania, 미국, 15423
        • 모병
        • Preferred Primary Care Physicians - St. Clair
        • 연락하다:
          • Preferred Primary Care Physicians - St. Clair
      • Sayre, Pennsylvania, 미국, 18840
        • 모병
        • Guthrie Medical Group, PC
        • 연락하다:
          • Guthrie Medical Group, PC
    • South Carolina
      • Anderson, South Carolina, 미국, 29621
        • 모병
        • Velocity Clinical Research - Anderson
        • 연락하다:
          • Velocity Clinical Research - Anderson
      • Rock Hill, South Carolina, 미국, 29732
        • 모병
        • Clinical Research of Rock Hill
        • 연락하다:
          • Clinical Research of Rock Hill
      • Spartanburg, South Carolina, 미국, 29303
        • 모병
        • Velocity Clinical Research - Spartanburg
        • 연락하다:
          • Velocity Clinical Research - Spartanburg
      • Union, South Carolina, 미국, 29379
        • 모병
        • Velocity Clinical Research - Union
        • 연락하다:
          • Velocity Clinical Research - Union
    • Texas
      • Dallas, Texas, 미국, 75230
        • 모집하지 않고 적극적으로
        • Zenos Clinical Research, LLC
      • Kingwood, Texas, 미국, 77339
        • 모집하지 않고 적극적으로
        • Activian Clinical Research - Kingwood
      • Lewisville, Texas, 미국, 75057
        • 모집하지 않고 적극적으로
        • Epic Clinical Research, LLC
      • Tomball, Texas, 미국, 77375
        • 모병
        • Activian Clinical Research - Tomball
        • 연락하다:
          • Activian Clinical Research - Tomball
  • 영국
      • Bromborough, 영국, CH62 6EE
        • 모병
        • FutureMeds Liverpool
        • 연락하다:
          • FutureMeds Liverpool
      • Glasgow, 영국, G20 7BE
        • 모병
        • FutureMeds Glasgow
        • 연락하다:
          • FutureMeds Glasgow
      • London, 영국, W12 0HS
        • 모병
        • Imperial College Healthcare NHS Trust
        • 연락하다:
          • Imperial College Healthcare NHS Trust
      • London, 영국, NW10 2PB
        • 모병
        • FutureMeds London
        • 연락하다:
          • FutureMeds London
      • London, 영국, RM1 1BH
        • 모병
        • Clinicalysis
        • 연락하다:
          • CLINICALYSIS
      • London, 영국, SE6 4LF
        • 모병
        • ProMed Innovations Clinical Research
        • 연락하다:
          • ProMed Innovations Clinical Research
      • London, 영국, NW1 0NH
        • 모병
        • Imperial Clinical Respiratory Research Unit
        • 연락하다:
          • Imperial Clinical Respiratory Research Unit
      • Milton Keynes, 영국, MK15 0DU
        • 모병
        • Bioluminux Clinical Research Milton Keynes
        • 연락하다:
          • Bioluminux Clinical Research Milton Keynes
      • Wolverhampton, 영국, WV9 5HB
        • 모병
        • Bioluminux Clinical Research Wolverhampton
        • 연락하다:
          • Bioluminux Clinical Research Wolverhampton

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 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion

Sign informed consent for study participation and medical records release (if needed).

Male or female age ≥40 years and ≤85 years at the time of signing the informed consent at Screening.

If sexually active and/or of child-bearing potential (both females and males), must agree to use a highly effective form of contraception at the time of randomization until 30 days (females) or 90 days (males) after the last dose. Female participants may not use hormonal birth control as a sole method. Participants will be asked to commit to this criterion at screening even though it does not need to be implemented until treatment is received. See Section 11.2 below.

Confirmed diagnosis of COPD, defined as chronic cough, sputum production, and/or dyspnea with airflow obstruction which is not fully reversible (that is, post bronchodilator FEV1/FVC ratio <0.70 and post bronchodilator FEV1 ≥20% and <80% of predicted normal value).

History of AECOPD with at least 1 documented AECOPD within 1 year of Screening.

  • AECOPD is defined as an event characterized by dyspnea and/or cough and increased sputum purulence/change in sputum color that worsens over several days, and requires at least one of the following for at least 2 days:
  • Increase frequency or dose of beta agonist(s), oxygen, breathing treatments or chronic COPD medications (Mild Exacerbation)
  • Use of oral or systemic steroids (Moderate Exacerbation), or
  • Use of Antibiotics (Moderate Exacerbation), or
  • Emergency room visit or hospitalization (Severe Exacerbation). CAT score ≥10 at screening. Able to comply with all study requirements, including the use of a mobile application to complete daily PROs, perform nasal swabs at home, and able to assess when they have cold symptoms.

Interacts with people at least twice a week without a mask (e.g., grocery shopping, dinner with grandchildren, eating at a restaurant, going to the movies, etc.) or are living in a multigenerational home.

Inclusion criteria to be assessed only at Randomization:

If on stable COPD maintenance therapy this should be stable for at least 2 months prior to randomization. Changes allowed with Sponsor approval (i.e., change within same class due to financial considerations and clinically stable).

Clinically stable with no other exacerbations or respiratory infections (viral or bacterial) within 2 months prior to randomization.

The presence of RV (without a co-infection) at the time of randomization based on an approved molecular diagnostic test.

To be randomized, participants must have at least 3 E-RS scores completed within the previous 35 days to establish a PSB.

Exclusion

Pregnant or nursing or expected to become pregnant during the study period. Experiencing a current/active or prior exacerbation within 2 months of the Screening Visit (these participants should be rescreened after the exacerbation has been resolved for two months).

Participants with other primary causes of chronic airflow limitation:

- Including but not limited to: asthma alone (COPD with asthmatic features is acceptable), CF, bronchiolitis obliterans, fibrosis such as TB, IPF, non-CF bronchiectasis with multi-lobe involvement or other major respiratory diagnosis (e.g., allergic bronchopulmonary aspergillosis), etc.

Any disorder, for example, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric impairment that is not medically stable, or other major physical impairment that is not considered by the investigator medically stable/controlled.

Participants with hepatitis B are excluded. Participants on a stable treatment for HIV can be permitted with permission from the medical monitor. Participants with hepatitis C should be treated and confirmed HCV RNA negative prior to enrollment. (Testing performed at the Screening Visit).

In the Investigator's opinion, the participant has any clinically significant laboratory abnormality including an abnormality that indicates clinically significant hematologic, hepatobiliary, or renal disease.

Presence of clinically significant out-of-range cardiac interval on the screening ECG including a QTcF > 450 msec (men) and a QTcF > 460 msec (women).

Medications or other non-medicinal products that could be impacted by CYP3A4, CYP2C8, or CYP2C19 induction and have serious complications for the participant within the treatment period.

Medications that are potent CYP2C8, CYP3A4 or CYP2C19 inducers that would reduce exposures of VPV.

Medications that are potent CYP2C8, CYP3A4, or CYP2C19 inhibitors that would increase exposures of VPV.

Medications that are substrates of MATE1, OAT3, P-gp, and BCRP for which elevated concentrations are associated with serious and/or life-threatening reactions.

Use of either of the following treatments:

  • Chronic oral/systemic steroids >10 mg per day (inhaled corticosteroids are permitted).
  • Continuous oxygen via nasal cannula of >2 L/min at the time of Screening or during the Asymptomatic Phase. (Participants on continuous oxygen may have the rate increased during physical exercise/ exertion or to cover any situationally induced decompensation, so long as the participant will resume a continuous rate of ≤2 L/min thereafter).

Participation in another investigational drug study within 5 half-lives prior to Screening and during the study is prohibited. This includes approved drugs being evaluated for a new indication. Observational studies are permitted.

Participants who have taken VPV in another clinical trial.

Exclusion criteria to be assessed only at Randomization:

It is already determined, based on the Investigator's clinical judgement, that the participant will likely need antibiotics and/or oral steroids at the Day 1 Randomization Visit.

On or within 7 days prior to randomization, there is another active diagnosed infection with viral or bacterial pathogens (i.e., urinary tract infection, cellulitis, etc.) that requires treatment.

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: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Dosing Group 1 VPV 1000 mg

The first dose of 1,000 mg VPV will be taken at the study site with food once the Day 1 visit is completed. The second dose of 1,000 mg VPV will be taken at home the following morning with food. The subsequent 1,000 mg doses will be taken every 24 hours with food from the time of the second dose for a total of 7 doses.
의약품: VPV 1000 mg

Vapendavir 1000 mg

다른 이름들:
  • Vapendavir
실험적: Dosing Group 2 VPV 500 mg

The first dose of 1,000 mg VPV will be taken at the study site with food once the Day 1 visit is completed. The second dose of 500 mg VPV will be taken at home the following morning with food. The subsequent 500 mg doses will be taken every 24 hours with food from the time of the second dose for a total of 7 doses.
의약품: VPV 1000 mg

Vapendavir 1000 mg

다른 이름들:
  • Vapendavir
의약품: VPV 500 mg

Vapendavir 500 mg

다른 이름들:
  • Vapendaivr
위약 비교기: Dosing Group 3 Placebo

The first dose of placebo will be taken at the study site with food once the Day 1 visit is completed. The second dose of placebo will be taken at home the following morning with food. The subsequent placebo doses will be taken every 24 hours with food from the time of the second dose for a total of 7 doses
다른: Placebo

Placebo

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Evaluating Respiratory Symptoms (E-RS)
기간: Baseline Period/Asymptomatic Phase: Daily for 12 weeks Treatment/Follow-Up Periods: Daily for up to 42 days

11-item E RS collected as part of the 14-item EXAcerbations of Chronic pulmonary disease Tool (EXACT PRO®) scale, with data from the additional 3 items from the EXACT PRO scale used for exploratory purposes only. The PSB will be calculated as the mean of the E-RS scores collected in the -35 to -6 days prior to RV symptom onset. If the E-RS score has not returned to PSB at the time of Day 28 Visit, the participant will complete the E-RS daily until Day 42. The questions are asked about how the participant feels today and will be collected at night.
Baseline Period/Asymptomatic Phase: Daily for 12 weeks Treatment/Follow-Up Periods: Daily for up to 42 days

2차 결과 측정

결과 측정
측정값 설명
기간
Patient Global Impression of Severity (PGIS)
기간: Baseline Period/Asymptomatic Phase: Daily for 12 weeks Treatment/Follow-Up Periods: Daily for up to 42 days

The PGIS is one question, 'Please rate the overall severity of your respiratory symptoms today? (none, mild, moderate, severe, very severe).'
Baseline Period/Asymptomatic Phase: Daily for 12 weeks Treatment/Follow-Up Periods: Daily for up to 42 days
Wisconsin Upper Respiratory Symptom Survey - 11
기간: Treatment/Follow-up Periods: Daily for 28 days

The questions are asked about how the participant feels today or within the last 24 hours. The questionnaire will be completed at night.
Treatment/Follow-up Periods: Daily for 28 days
Change from Baseline in Respiratory System Resistance at 5 Hz (R5) Measured by Oscillometry
기간: Screening Visit, Day 1, Day 3, Day 7, Day 14, Day 28, Day 42

Respiratory system resistance at an oscillation frequency of 5 Hz, measured by oscillometry during unforced tidal breathing. R5 reflects total respiratory system resistance and is a measure of overall airway caliber. Values are reported as the mean of at least three technically acceptable measurements, performed according to the 2020 European Respiratory Society / American Thoracic Society technical standards for respiratory oscillometry. Unit of measure: cmH₂O·s/L.
Screening Visit, Day 1, Day 3, Day 7, Day 14, Day 28, Day 42
Change from Baseline in Respiratory System Resistance at 20 Hz (R20) Measured by Oscillometry
기간: Screening Visit, Day 1, Day 3, Day 7, Day 14, Day 28, Day 42

Respiratory system resistance at an oscillation frequency of 20 Hz, measured by oscillometry during unforced tidal breathing. R20 predominantly reflects large/central airway resistance, as higher-frequency oscillations do not penetrate the peripheral airways. Values are reported as the mean of at least three technically acceptable measurements, performed according to the 2020 European Respiratory Society / American Thoracic Society technical standards for respiratory oscillometry. Unit of measure: cmH₂O·s/L.
Screening Visit, Day 1, Day 3, Day 7, Day 14, Day 28, Day 42
Change from Baseline in Frequency Dependence of Resistance (R5-R20) Measured by Oscillometry
기간: Screening Visit, Day 1, Day 3, Day 7, Day 14, Day 28, Day 42

The difference between respiratory system resistance measured at 5 Hz and at 20 Hz (R5 minus R20), measured by oscillometry during unforced tidal breathing. R5-R20 is interpreted as an index of small airway dysfunction, with elevated values indicating heterogeneity of peripheral airway resistance. Values are calculated from the mean of at least three technically acceptable measurements at each frequency, performed according to the 2020 European Respiratory Society / American Thoracic Society technical standards for respiratory oscillometry. Unit of measure: cmH₂O·s/L.
Screening Visit, Day 1, Day 3, Day 7, Day 14, Day 28, Day 42
Change from Baseline in Respiratory System Reactance at 5 Hz (X5) Measured by Oscillometry
기간: Screening Visit, Day 1, Day 3, Day 7, Day 14, Day 28, Day 42

Respiratory system reactance at an oscillation frequency of 5 Hz, measured by oscillometry during unforced tidal breathing. X5 represents the elastic and inertive properties of the respiratory system at low frequency and becomes more negative with increased peripheral airway obstruction or reduced lung compliance. Values are reported as the mean of at least three technically acceptable measurements, performed according to the 2020 European Respiratory Society / American Thoracic Society technical standards for respiratory oscillometry. Unit of measure: cmH₂O·s/L.
Screening Visit, Day 1, Day 3, Day 7, Day 14, Day 28, Day 42
Change from Baseline in Area Under the Reactance Curve (AX) Measured by Oscillometry
기간: Screening Visit, Day 1, Day 3, Day 7, Day 14, Day 28, Day 42

The integrated area of the reactance curve from 5 Hz to the resonant frequency, measured by oscillometry during unforced tidal breathing. AX reflects the total elastic and inertive load of the respiratory system and is a sensitive composite index of peripheral airway dysfunction. Values are reported as the mean of at least three technically acceptable measurements, performed according to the 2020 European Respiratory Society / American Thoracic Society technical standards for respiratory oscillometry. Unit of measure: cmH₂O/L.
Screening Visit, Day 1, Day 3, Day 7, Day 14, Day 28, Day 42
Change from Baseline in Resonant Frequency (Fres) Measured by Oscillometry
기간: Screening Visit, Day 1, Day 3, Day 7, Day 14, Day 28, Day 42

The oscillation frequency at which respiratory system reactance equals zero, measured by oscillometry during unforced tidal breathing. Fres represents the frequency at which the inertive and elastic forces of the respiratory system are equal in magnitude and opposite in direction; it shifts to higher frequencies with peripheral airway obstruction. Values are reported as the mean of at least three technically acceptable measurements, performed according to the 2020 European Respiratory Society / American Thoracic Society technical standards for respiratory oscillometry. Unit of measure: Hz.
Screening Visit, Day 1, Day 3, Day 7, Day 14, Day 28, Day 42
Change from Baseline in Forced Expiratory Volume in 1 Second (FEV1) - Absolute Value
기간: Screening Visit, and Days 7, 14, 28 and 42

Forced expiratory volume in the first second of a maximal forced expiration following a full inspiration, measured by spirometry. FEV1 is a primary index of airflow obstruction. Values are reported as the highest acceptable value from at least three acceptable and two repeatable maneuvers, performed according to the 2019 European Respiratory Society / American Thoracic Society standards for spirometry. Unit of measure: liters.
Screening Visit, and Days 7, 14, 28 and 42
Change from Baseline in Forced Expiratory Volume in 1 Second (FEV1) - Percent Predicted
기간: Screening Visit, Day 7, Day 14, Day 28, Day 42

Forced expiratory volume in the first second expressed as a percentage of the predicted value for the participant's age, sex, height, and ethnicity using the Global Lung Function Initiative (GLI-2012) reference equations. Measured by spirometry according to the 2019 European Respiratory Society / American Thoracic Society standards. Unit of measure: percent of predicted (%).
Screening Visit, Day 7, Day 14, Day 28, Day 42
Change from Baseline in Forced Vital Capacity (FVC) - Absolute Value
기간: Screening Visit, Day 7, Day 14, Day 28, Day 42

Forced vital capacity, defined as the maximum volume of air exhaled with maximally forced effort from a position of maximal inspiration, measured by spirometry. Values are reported as the highest acceptable value from at least three acceptable and two repeatable maneuvers, performed according to the 2019 European Respiratory Society / American Thoracic Society standards for spirometry. Unit of measure: liters.
Screening Visit, Day 7, Day 14, Day 28, Day 42
Change from Baseline in Forced Vital Capacity (FVC) - Percent Predicted
기간: Screening Visit, Day 7, Day 14, Day 28, Day 42

Forced vital capacity expressed as a percentage of the predicted value for the participant's age, sex, height, and ethnicity using the Global Lung Function Initiative (GLI-2012) reference equations. Measured by spirometry according to the 2019 European Respiratory Society / American Thoracic Society standards. Unit of measure: percent of predicted (%).
Screening Visit, Day 7, Day 14, Day 28, Day 42
Change from Baseline in FEV1/FVC Ratio
기간: Screening Visit, Day 7, Day 14, Day 28, Day 42

The ratio of forced expiratory volume in 1 second (FEV1) to forced vital capacity (FVC), calculated from the highest acceptable FEV1 and FVC obtained during the same testing session. The FEV1/FVC ratio is the principal spirometric criterion used to identify airflow obstruction. Measured by spirometry according to the 2019 European Respiratory Society / American Thoracic Society standards. Unit of measure: ratio.
Screening Visit, Day 7, Day 14, Day 28, Day 42
Change from Baseline in Peak Expiratory Flow (PEF) - Absolute Value
기간: Screening Visit, Day 7, Day 14, Day 28, Day 42

Peak expiratory flow, defined as the highest flow achieved during a maximally forced expiration starting from a position of maximal inspiration, measured by spirometry. Values are reported as the highest acceptable value from at least three acceptable and two repeatable maneuvers, performed according to the 2019 European Respiratory Society / American Thoracic Society standards for spirometry. Unit of measure: liters per minute (L/min).
Screening Visit, Day 7, Day 14, Day 28, Day 42
Change from Baseline in Peak Expiratory Flow (PEF) - Percent Predicted
기간: Screening Visit, Day 7, Day 14, Day 28, Day 42

Peak expiratory flow expressed as a percentage of the predicted value for the participant's age, sex, height, and ethnicity using the Global Lung Function Initiative (GLI-2012) reference equations. Measured by spirometry according to the 2019 European Respiratory Society / American Thoracic Society standards. Unit of measure: percent of predicted (%).
Screening Visit, Day 7, Day 14, Day 28, Day 42

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Altesa Biosciences, Inc.

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)

2026년 5월 1일

기본 완료 (추정된)

2027년 11월 15일

연구 완료 (추정된)

2027년 11월 15일

연구 등록 날짜

최초 제출

2026년 5월 12일

QC 기준을 충족하는 최초 제출

2026년 5월 22일

처음 게시됨 (실제)

2026년 5월 28일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 10월 22일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 10월 21일

마지막으로 확인됨

2026년 10월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • ALT-VPV-203

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

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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