Single Dose Study to Assess Efficacy, Safety and Tolerability of LAS100977 in Asthmatic Patients.
7. května 2018 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Podmínky
Typ studie
Intervenční
Zápis (Aktuální)
62
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 místa
-
-
-
Berlin, Německo, 10117
- Almirall Investigational Sites#6
-
Berlin, Německo, 14050
- Almirall Investigational Sites#4
-
Berlin, Německo, 14057
- Almirall Investigational Sites#1
-
Frankfurt, Německo, 60596
- Almirall Investigational Sites#3
-
Grosshansdorf, Německo, 22927
- Almirall Investigational Sites#2
-
Hamburg, Německo, 20249
- Almirall Investigational Sites#8
-
Wiesbaden, Německo, 65187
- Almirall Investigational Sites#5
-
-
-
-
-
London, Spojené království, W1G 8HT
- Almirall Investigational Sites#2
-
Manchester, Spojené království, M3 9QZ
- Almirall Investigational Sites#1
-
-
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
18 let až 70 let (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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.
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: Crossover Assignment
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: LAS100977 0.625 μg
Single-dose LAS100977 0.625 μg, during double-blind treatment period
|
Dry powder inhalation, once-daily, single-dose
Pressurized inhalation, once-daily
|
|
Experimentální: LAS100977 1.25 μg
Single-dose LAS100977 1.25 μg, during double-blind treatment period
|
Pressurized inhalation, once-daily
Dry powder inhalation, once-daily, single-dose
|
|
Experimentální: LAS100977 2.5 μg
Single-dose LAS100977 2.5 μg, during double-blind treatment period
|
Pressurized inhalation, once-daily
Dry powder inhalation, once-daily, single-dose
|
|
Aktivní komparátor: Salbutamol
Single-dose salbutamol 400 μg, during double-blind treatment period
|
Pressurized inhalation suspension, once-daily, single-dose
Dry powder inhalation, once-daily
|
|
Komparátor placeba: Placebo
Placebo to LAS100977, and placebo to salbutamol
|
Pressurized inhalation, once-daily
Dry powder inhalation, once-daily
|
|
Experimentální: LAS100977 0.313 μg
Single-dose LAS100977 0.313 μg, during double-blind treatment period
|
Pressurized inhalation, once-daily
Dry powder inhalation, once-daily, single-dose
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1)
Časové okno: 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.
|
Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Percentage Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1)
Časové okno: 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.
|
Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose
|
|
Peak Forced Expiratory Volume in One Second (FEV1)
Časové okno: +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 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.
|
+15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose
|
|
Time to Peak Forced Expiratory Volume in One Second (FEV1)
Časové okno: +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.
|
+15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose
|
|
Change From Baseline to Trough Forced Expiratory Volume in One Second (FEV1)
Časové okno: 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.
|
Baseline and +23 h and +24 h post-dose
|
|
Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-24h at Day 1
Časové okno: 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
|
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
|
|
Absolute Values of Forced Expiratory Volume (FEV1) at Each Timepoint
Časové okno: 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.
|
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 Expiratory Volume (FEV1) at Each Timepoint
Časové okno: 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
|
|
Percentage Change From Baseline in Forced Expiratory Volume (FEV1) at Each Timepoint
Časové okno: 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 Peak Forced Vital Capacity (FVC)
Časové okno: 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.
|
Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose
|
|
Peak Forced Vital Capacity (FVC)
Časové okno: +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)
Časové okno: +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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Ředitel studie: Carol Astbury, PhD, AstraZeneca
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Užitečné odkazy
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. srpna 2011
Primární dokončení (Aktuální)
1. února 2012
Dokončení studie (Aktuální)
1. února 2012
Termíny zápisu do studia
První předloženo
29. srpna 2011
První předloženo, které splnilo kritéria kontroly kvality
29. srpna 2011
První zveřejněno (Odhad)
30. srpna 2011
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
8. května 2018
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
7. května 2018
Naposledy ověřeno
1. dubna 2018
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Nemoci dýchacích cest
- Onemocnění imunitního systému
- Plicní onemocnění
- Přecitlivělost, okamžitá
- Bronchiální onemocnění
- Plicní onemocnění, obstrukční
- Respirační přecitlivělost
- Přecitlivělost
- Astma
- Fyziologické účinky léků
- Adrenergní látky
- Neurotransmiterové látky
- Molekulární mechanismy farmakologického působení
- Autonomní agenti
- Agenti periferního nervového systému
- Adrenergní agonisté
- Bronchodilatační činidla
- Antiastmatická činidla
- Agenti dýchacího systému
- Činidla pro kontrolu reprodukce
- Agonisté adrenergních beta-2 receptorů
- Adrenergní beta-agonisté
- Tokolytická činidla
- Albuterol
Další identifikační čísla studie
- M/100977/202
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 .
Klinické studie na LAS100977 0.625 μg
-
AstraZenecaDokončenoChronická obstrukční plicní nemoc (CHOPN)Německo
-
Alebund Pty LtdDokončenoZdravé předmětyAustrálie
-
GlaxoSmithKlineDokončenoCOVID-19 | SARS-CoV-2Filipíny, Spojené státy, Austrálie
-
Alebund PharmaceuticalsDokončeno
-
Atridia Pty Ltd.Linear Clinical ResearchDokončeno
-
CytoAgents, Inc.TFS HealthScienceNáborSyndrom uvolňování cytokinůSpojené státy
-
AstraZenecaDokončeno
-
Judit Pich MartínezDokončeno
-
University of OxfordZatím nenabírámeVaccine Reaction | Malárie | Malárie Plasmodium FalciparumBangladéš
-
GlaxoSmithKlineDokončenoPlicní onemocnění, chronická obstrukčníJaponsko