Single Dose Study to Assess Efficacy, Safety and Tolerability of LAS100977 in Asthmatic Patients.
2018. május 7. frissítette: 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.
A tanulmány áttekintése
Állapot
Befejezve
Körülmények
Tanulmány típusa
Beavatkozó
Beiratkozás (Tényleges)
62
Fázis
- 2. fázis
Kapcsolatok és helyek
Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.
Tanulmányi helyek
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London, Egyesült Királyság, W1G 8HT
- Almirall Investigational Sites#2
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Manchester, Egyesült Királyság, M3 9QZ
- Almirall Investigational Sites#1
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Berlin, Németország, 10117
- Almirall Investigational Sites#6
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Berlin, Németország, 14050
- Almirall Investigational Sites#4
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Berlin, Németország, 14057
- Almirall Investigational Sites#1
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Frankfurt, Németország, 60596
- Almirall Investigational Sites#3
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Grosshansdorf, Németország, 22927
- Almirall Investigational Sites#2
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Hamburg, Németország, 20249
- Almirall Investigational Sites#8
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Wiesbaden, Németország, 65187
- Almirall Investigational Sites#5
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Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
18 év (Felnőtt, Idősebb felnőtt)
Egészséges önkénteseket fogad
Nem
Tanulmányozható nemek
Összes
Leírás
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.
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Crossover kiosztás
- Maszkolás: Kettős
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
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Kísérleti: 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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Kísérleti: 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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Kísérleti: 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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Aktív összehasonlító: 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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Kísérleti: 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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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1)
Időkeret: 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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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Percentage Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1)
Időkeret: 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)
Időkeret: +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.
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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)
Időkeret: +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
|
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Change From Baseline to Trough Forced Expiratory Volume in One Second (FEV1)
Időkeret: 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
Időkeret: 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.
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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 and +24 h
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Absolute Values of Forced Expiratory Volume (FEV1) at Each Timepoint
Időkeret: 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
|
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Change From Baseline in Forced Expiratory Volume (FEV1) at Each Timepoint
Időkeret: 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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Percentage Change From Baseline in Forced Expiratory Volume (FEV1) at Each Timepoint
Időkeret: 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)
Időkeret: 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)
Időkeret: +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)
Időkeret: +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)
Időkeret: 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)
Időkeret: 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
Időkeret: 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
Időkeret: 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
|
Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Szponzor
Nyomozók
- Tanulmányi igazgató: Carol Astbury, PhD, AstraZeneca
Publikációk és hasznos linkek
A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.
Hasznos linkek
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
2011. augusztus 1.
Elsődleges befejezés (Tényleges)
2012. február 1.
A tanulmány befejezése (Tényleges)
2012. február 1.
Tanulmányi regisztráció dátumai
Először benyújtva
2011. augusztus 29.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2011. augusztus 29.
Első közzététel (Becslés)
2011. augusztus 30.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
2018. május 8.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2018. május 7.
Utolsó ellenőrzés
2018. április 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
- Légúti betegségek
- Immunrendszeri betegségek
- Tüdőbetegségek
- Túlérzékenység, azonnali
- Bronchiális betegségek
- Tüdőbetegségek, obstruktív
- Légúti túlérzékenység
- Túlérzékenység
- Asztma
- A gyógyszerek élettani hatásai
- Adrenerg szerek
- Neurotranszmitter szerek
- A farmakológiai hatás molekuláris mechanizmusai
- Autonóm ügynökök
- Perifériás idegrendszeri szerek
- Adrenerg agonisták
- Hörgőtágító szerek
- Asztmaellenes szerek
- Légzőrendszeri szerek
- Reprodukciós szabályozó szerek
- Adrenerg béta-2 receptor agonisták
- Adrenerg béta-agonisták
- Tocolitikus szerek
- Albuterol
Egyéb vizsgálati azonosító számok
- M/100977/202
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .