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

8. září 2026 aktualizováno: 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.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Odhadovaný)

180

Fáze

  • Fáze 2

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Čtyřnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Lék: VPV 1000 mg
Vapendavir 1000 mg
Ostatní jména:
  • Vapendavir
Experimentální: 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.
Lék: VPV 1000 mg
Vapendavir 1000 mg
Ostatní jména:
  • Vapendavir
Lék: VPV 500 mg
Vapendavir 500 mg
Ostatní jména:
  • Vapendaivr
Komparátor placeba: 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
Jiný: Placebo
Placebo

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Evaluating Respiratory Symptoms (E-RS)
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Patient Global Impression of Severity (PGIS)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Altesa Biosciences, Inc.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

1. května 2026

Primární dokončení (Odhadovaný)

15. listopadu 2027

Dokončení studie (Odhadovaný)

15. listopadu 2027

Termíny zápisu do studia

První předloženo

12. května 2026

První předloženo, které splnilo kritéria kontroly kvality

22. května 2026

První zveřejněno (Aktuální)

28. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

10. září 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

8. září 2026

Naposledy ověřeno

1. září 2026

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • ALT-VPV-203

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ano

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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