Single Dose Study to Assess Efficacy, Safety and Tolerability of LAS100977 in Asthmatic Patients.
maanantai 7. toukokuuta 2018 päivittänyt: AstraZeneca
A Phase IIa, Randomised, Single Dose, Double-blind, Double-dummy, 6 Way Complete Cross-over, Placebo Controlled Clinical Trial to Assess the Efficacy, Safety and Tolerability of 4 Doses of LAS100977 QD Compared to Placebo and an Active Comparator in Patients With Persistent Asthma.
The purpose of this study is to evaluate the pharmacodynamics of single doses of inhaled LAS100977 QD in patients with persistent asthma.
Tutkimuksen yleiskatsaus
Tila
Valmis
Ehdot
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
62
Vaihe
- Vaihe 2
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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Berlin, Saksa, 10117
- Almirall Investigational Sites#6
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Berlin, Saksa, 14050
- Almirall Investigational Sites#4
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Berlin, Saksa, 14057
- Almirall Investigational Sites#1
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Frankfurt, Saksa, 60596
- Almirall Investigational Sites#3
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Grosshansdorf, Saksa, 22927
- Almirall Investigational Sites#2
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Hamburg, Saksa, 20249
- Almirall Investigational Sites#8
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Wiesbaden, Saksa, 65187
- Almirall Investigational Sites#5
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London, Yhdistynyt kuningaskunta, W1G 8HT
- Almirall Investigational Sites#2
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Manchester, Yhdistynyt kuningaskunta, M3 9QZ
- Almirall Investigational Sites#1
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
18 vuotta - 70 vuotta (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Ei
Sukupuolet, jotka voivat opiskella
Kaikki
Kuvaus
Inclusion Criteria:
- Adult male and female patients aged 18-70 years (both included).
- Clinical diagnosis of persistent asthma (according to GINA guidelines 2009 update) for at least 6 months prior to screening.
- Screening FEV1 value of 60% < FEV1 ≤ 85% of the predicted normal value.
- FEV1 reversibility ≥ 12% and an absolute increase of at least 200 ml over baseline value after inhalation of 400µg (four inhalations) of salbutamol.
- Pre-dose FEV1 value of first treatment period within the range of ± 20% of the FEV1 measured at screening prior to salbutamol inhalation.
- Patients on a stable dose and regimen
Exclusion Criteria:
- Current smokers, former smokers within the last 6 months, or ex-smokers with a history of more than 10 pack-years.
- Patients diagnosed with COPD.
- Recent Respiratory tract infections within 6 weeks before Screening Visit.
- Intubation (ever) or hospitalization for longer than 24 hours for the management of an asthma exacerbation within the preceding 6 weeks of the screening visit.
- Clinically significant respiratory conditions.
- Clinically significant cardiovascular conditions.
- Patients unable to properly use a dry powder or pMDI inhaler device or unable to perform acceptable spirometry.
- Clinically relevant abnormalities laboratory, ECG parameters or physical examination results at the screening evaluation that in the investigator's opinion, preclude study participation.
- Patients who intend to use any concomitant medication not permitted by this protocol or who have not undergone the required washout period for a particular prohibited medication.
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Crossover-tehtävä
- Naamiointi: Kaksinkertainen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Kokeellinen: LAS100977 0.625 μg
Single-dose LAS100977 0.625 μg, during double-blind treatment period
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Dry powder inhalation, once-daily, single-dose
Pressurized inhalation, once-daily
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Kokeellinen: LAS100977 1.25 μg
Single-dose LAS100977 1.25 μg, during double-blind treatment period
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Pressurized inhalation, once-daily
Dry powder inhalation, once-daily, single-dose
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Kokeellinen: LAS100977 2.5 μg
Single-dose LAS100977 2.5 μg, during double-blind treatment period
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Pressurized inhalation, once-daily
Dry powder inhalation, once-daily, single-dose
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Active Comparator: Salbutamol
Single-dose salbutamol 400 μg, during double-blind treatment period
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Pressurized inhalation suspension, once-daily, single-dose
Dry powder inhalation, once-daily
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Placebo Comparator: Placebo
Placebo to LAS100977, and placebo to salbutamol
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Pressurized inhalation, once-daily
Dry powder inhalation, once-daily
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Kokeellinen: LAS100977 0.313 μg
Single-dose LAS100977 0.313 μg, during double-blind treatment period
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Pressurized inhalation, once-daily
Dry powder inhalation, once-daily, single-dose
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1)
Aikaikkuna: Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose
|
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min).
The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning.
At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 were selected.
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Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Percentage Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1)
Aikaikkuna: Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose
|
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min).
The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning.
At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 were selected.
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Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose
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Peak Forced Expiratory Volume in One Second (FEV1)
Aikaikkuna: +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose
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The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning on Day 1.
At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 were selected.
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+15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose
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Time to Peak Forced Expiratory Volume in One Second (FEV1)
Aikaikkuna: +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose
|
The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning.
At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 were selected.
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+15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose
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Change From Baseline to Trough Forced Expiratory Volume in One Second (FEV1)
Aikaikkuna: Baseline and +23 h and +24 h post-dose
|
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min).
Trough at Day 2 was computed as the average of the two values measured at 23 and 24 hours after administration of the morning dose of investigational medicinal product on Day 1.
At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.
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Baseline and +23 h and +24 h post-dose
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Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-24h at Day 1
Aikaikkuna: Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h and +24 h
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FEV1 was normalized to baseline.
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min).
At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.
|
Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h and +24 h
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Absolute Values of Forced Expiratory Volume (FEV1) at Each Timepoint
Aikaikkuna: Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h
|
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min).
At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.
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Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h
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Change From Baseline in Forced Expiratory Volume (FEV1) at Each Timepoint
Aikaikkuna: Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h
|
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min).
At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.
The number of participants analyzed differed between timepoints - the number of participants analyzed at 0.25 h is shown.
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Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h
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Percentage Change From Baseline in Forced Expiratory Volume (FEV1) at Each Timepoint
Aikaikkuna: Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h
|
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min).
At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.
The number of participants analyzed differed between timepoints - the number of participants analyzed at 0.25 h is shown.
|
Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h
|
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Change From Baseline in Peak Forced Vital Capacity (FVC)
Aikaikkuna: Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose
|
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min).
The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning.
At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.
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Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose
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Peak Forced Vital Capacity (FVC)
Aikaikkuna: +15 min, +30 min, +1 h, +2 h, +3 h, +4 h
|
The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning.
At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.
|
+15 min, +30 min, +1 h, +2 h, +3 h, +4 h
|
|
Time to Peak Forced Vital Capacity (FVC)
Aikaikkuna: +15 min, +30 min, +1 h, +2 h, +3 h, +4 h
|
The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning.
At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.
|
+15 min, +30 min, +1 h, +2 h, +3 h, +4 h
|
|
Change From Baseline to Trough Forced Vital Capacity (FVC)
Aikaikkuna: Baseline and +23 h +24 h post-dose
|
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min).
Trough at Day 2 was computed as the average of the two values measured at 23 and 24 hours after administration of the morning dose of investigational medicinal product on Day 1.
At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.
|
Baseline and +23 h +24 h post-dose
|
|
Change From Baseline in Normalized Forced Vital Capacity (FVC) Area Under the Curve (AUC)
Aikaikkuna: Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h and +24 h
|
FVC was normalized to baseline.
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min).
At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.
|
Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h and +24 h
|
|
Absolute Values of Forced Vital Capacity (FVC) at Each Timepoint
Aikaikkuna: Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h
|
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min).
At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.
The number of participants analyzed differed between timepoints - the number of participants analyzed at 0.25 h is shown.
|
Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h
|
|
Change From Baseline in Forced Vital Capacity (FVC) at Each Timepoint
Aikaikkuna: Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h
|
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min).
At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.
The number of participants analyzed differed between timepoints - the number of participants analyzed at 0.25 h is shown.
|
Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h
|
Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Tutkijat
- Opintojohtaja: Carol Astbury, PhD, AstraZeneca
Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
Hyödyllisiä linkkejä
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Maanantai 1. elokuuta 2011
Ensisijainen valmistuminen (Todellinen)
Keskiviikko 1. helmikuuta 2012
Opintojen valmistuminen (Todellinen)
Keskiviikko 1. helmikuuta 2012
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Maanantai 29. elokuuta 2011
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Maanantai 29. elokuuta 2011
Ensimmäinen Lähetetty (Arvio)
Tiistai 30. elokuuta 2011
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Tiistai 8. toukokuuta 2018
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Maanantai 7. toukokuuta 2018
Viimeksi vahvistettu
Sunnuntai 1. huhtikuuta 2018
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
- Hengityselinten sairaudet
- Immuunijärjestelmän sairaudet
- Keuhkosairaudet
- Yliherkkyys, välitön
- Keuhkoputken sairaudet
- Keuhkosairaudet, obstruktiiviset
- Hengitysteiden yliherkkyys
- Yliherkkyys
- Astma
- Huumeiden fysiologiset vaikutukset
- Adrenergiset aineet
- Neurotransmitterit
- Farmakologisen vaikutuksen molekyylimekanismit
- Autonomiset agentit
- Ääreishermoston aineet
- Adrenergiset agonistit
- Keuhkoputkia laajentavat aineet
- Astmaattiset aineet
- Hengityselinten aineet
- Lisääntymistä säätelevät aineet
- Adrenergiset beeta-2-reseptoriagonistit
- Adrenergiset beeta-agonistit
- Tokolyyttiset aineet
- Albuteroli
Muut tutkimustunnusnumerot
- M/100977/202
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .
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-
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