- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT01013753
A Study of the Safety and Efficacy of 4 Doses of BI 1744 CL Delivered Via the Respimat in Patients With Asthma.
17. června 2014 aktualizováno: Boehringer Ingelheim
A Randomised, Double-Blind, Placebo- and Active-Controlled, Incomplete Crossover Efficacy and Safety Comparison of 4-week Treatment Periods of Once Daily Treatment of 4 Doses of BI 1744 CL Inhalation Solution Delivered by the Respimat® in Patients With Asthma
The primary objective of this study is to determine the efficacy and safety of 4 doses of BI 1744 CL inhalation solution delivered by the Respimat® inhaler once daily for four weeks in patients with asthma in comparison to placebo.
Přehled studie
Postavení
Dokončeno
Podmínky
Typ studie
Intervenční
Zápis (Aktuální)
198
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
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Berlin, Německo
- 1222.27.49003 Boehringer Ingelheim Investigational Site
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Berlin, Německo
- 1222.27.49004 Boehringer Ingelheim Investigational Site
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Berlin, Německo
- 1222.27.49009 Boehringer Ingelheim Investigational Site
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Frankfurt, Německo
- 1222.27.49011 Boehringer Ingelheim Investigational Site
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Hannover, Německo
- 1222.27.49008 Boehringer Ingelheim Investigational Site
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Lübeck, Německo
- 1222.27.49002 Boehringer Ingelheim Investigational Site
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Rüdersdorf, Německo
- 1222.27.49007 Boehringer Ingelheim Investigational Site
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Wiesbaden, Německo
- 1222.27.49006 Boehringer Ingelheim Investigational Site
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Wiesloch, Německo
- 1222.27.49010 Boehringer Ingelheim Investigational Site
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Lodz, Polsko
- 1222.27.48001 Boehringer Ingelheim Investigational Site
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Lodz, Polsko
- 1222.27.48002 Boehringer Ingelheim Investigational Site
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Poznan, Polsko
- 1222.27.48003 Boehringer Ingelheim Investigational Site
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Proszowice, Polsko
- 1222.27.48004 Boehringer Ingelheim Investigational Site
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Linz, Rakousko
- 1222.27.43002 Boehringer Ingelheim Investigational Site
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Schlüsslberg, Rakousko
- 1222.27.43004 Boehringer Ingelheim Investigational Site
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Thalheim bei Wels, Rakousko
- 1222.27.43001 Boehringer Ingelheim Investigational Site
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Wien, Rakousko
- 1222.27.43003 Boehringer Ingelheim Investigational Site
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Bucharest, Rumunsko
- 1222.27.40002 Boehringer Ingelheim Investigational Site
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Bucharest, Rumunsko
- 1222.27.40003 Boehringer Ingelheim Investigational Site
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Bardejov, Slovensko
- 1222.27.42101 Boehringer Ingelheim Investigational Site
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Lucenec, Slovensko
- 1222.27.42103 Boehringer Ingelheim Investigational Site
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Martin, Slovensko
- 1222.27.42104 Boehringer Ingelheim Investigational Site
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Spisska Nova Ves, Slovensko
- 1222.27.42102 Boehringer Ingelheim Investigational Site
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Golnik, Slovinsko
- 1222.27.38601 Boehringer Ingelheim Investigational Site
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Hoce, Slovinsko
- 1222.27.38603 Boehringer Ingelheim Investigational Site
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Kamnik, Slovinsko
- 1222.27.38605 Boehringer Ingelheim Investigational Site
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Topolsica, Slovinsko
- 1222.27.38604 Boehringer Ingelheim Investigational Site
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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:
- All patients must sign an informed consent consistent with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) guidelines prior to participation in the trial, i.e. prior to any study procedures which includes medication washout and restrictions. A separate informed consent is required for pharmacogenomic sampling.
- Male or female patients, aged between 18 and 70 years of age, diurnally active
- A history of asthma diagnosed by physician at least 3 months prior to Visit 1 at GINA treatment steps 3 or 4. The diagnosis of asthma must have been made before the age of 40.
- Pre-bronchodilator FEV1 between 60% predicted and 90% predicted at Visit 1.
- Increase in FEV1 greater or equal to 12% and 200 ml 15 minutes after 400mcg salbutamol (albuterol) at Visit 1.
- Patient must have been taking inhaled corticosteroids (ICS) for at least 12 weeks prior to screening, and must have been receiving at a stable dose for at least 6 weeks prior to screening either: - a medium to high dose ICS or - a low to high dose ICS in combination with Long acting beta agonist (LABA).
- All patients must be symptomatic.
Exclusion criteria:
- Patients with a significant disease other than asthma; a significant disease is defined as a disease which, in the opinion of the investigator, may (i) put the patient at risk because of participation in the study, (ii) influence the results of the study, or (iii) cause concern regarding the patient's ability to participate in the study
- Patients who have been hospitalised for an asthma exacerbation within 3 months or had an admission to an intensive care unit for asthma within 3 years of Visit 1
- Patients will be excluded when they have: - an aspartate aminotransferase (AST) >80 IU/L, alanine aminotransferase (ALT) >80 IU/L, bilirubin >1.5 X upper limit of normal (ULN) or creatinine >1.5 X ULN - clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis
Patients with any of the following conditions: - a diagnosis of thyrotoxicosis
- a diagnosis of paroxysmal tachycardia (>100 beats per minute)
- a marked baseline prolongation of QT/QTc interval at Visit 1 (e.g., repeated demonstration of a QTc interval >450 ms) as recommended by ICH E14
- a history of additional risk factors for Torsade de Pointes (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome) as recommended by ICH E14.
Patients with any of the following conditions: - a history of myocardial infarction within 1 year of screening visit (Visit 1)
- a diagnosis of clinically relevant cardiac arrhythmia
- a history of cor pulmonale
- known active tuberculosis
- a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years (patients with treated basal cell carcinoma are allowed)
- a history of life-threatening pulmonary obstruction
- a history of chronic obstructive pulmonary disease
- history of cystic fibrosis
- clinically evident bronchiectasis
- a history of significant alcohol or drug abuse
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 |
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Komparátor placeba: Placebo
Placebo olodaterol (BI 1744) inhalované jednou denně z inhalátoru Respimat a/nebo placebo Formoterol inhalované dvakrát denně z inhalátoru Aerolizer
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Determine efficacy and safety of Placebo inhaled once daily from the Respimat inhaler and/or twice daily from the Aerolizer inhaler
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Experimentální: Olodaterol (BI 1744) low
Low dose inhaled orally once daily from the Respimat inhaler
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Determine efficacy and safety of 4 different doses of Olodaterol (BI 1744) inhaled once daily via the Respimat
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Experimentální: Olodaterol (BI 1744) very low
Very low dose inhaled orally once daily from the Respimat inhaler
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Determination of efficacy in 4 different doses of Olodaterol (BI 1744) inhaled once daily via the Respimat
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Experimentální: Olodaterol (BI 1744) medium
Medium dose inhaled orally once daily from the Respimat inhaler
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Determination of efficacy in 4 different doses of Olodaterol (BI 1744) inhaled once daily via the Respimat
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Experimentální: Olodaterol (BI 1744) high
High dose inhaled orally once daily from the Respimat inhaler
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Determine efficacy and safety in 4 different doses of Olodaterol (BI 1744) inhaled once daily via the Respimat
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Aktivní komparátor: Formoterol 12 mcg
12mcg inhaled twice daily from the Aerolizer inhaler
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Determine efficacy and safety of 12 mcg Formoterol dose inhaled orally twice daily from the Aerolizer in comparison to other treatment groups
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-24 Hours (AUC 0-24h) Response at the End of Each Treatment Period
Časové okno: 1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks
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Response was defined as change from baseline.
Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit.
Means are adjusted for treatment, period, patient and study baseline.
FEV1 AUC 0-24h was calculated from 0-24 hours post-dose using the trapezoidal rule, divided by the observation time (24h) to report in litres.
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1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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FEV1 Area Under Curve 0-12 h (AUC 0-12h) Response at the End of Each Treatment Period
Časové okno: 1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min related to evening dose after 4 weeks
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Response was defined as change from baseline.
Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit.
Means are adjusted for treatment, period, patient and study baseline.
FEV1 AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.
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1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min related to evening dose after 4 weeks
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FEV1 Area Under Curve 12-24 h (AUC 12-24h) Response at the End of Each Treatment Period
Časové okno: 1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks
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Response was defined as change from baseline.
Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit.
Means are adjusted for treatment, period, patient and study baseline.
FEV1 AUC 12-24h was calculated from 12-24 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.
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1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks
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Peak FEV1 Within 24 Hours Post-dose Response
Časové okno: 1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks
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Response was defined as change from baseline.
Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit.
Peak FEV1 within 24 hours post dose measured following the evening trial drug inhalation at the end of each 4 week period of randomised treatment.
Means are adjusted for treatment, period, patient and study baseline.
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1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks
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Trough FEV1 Response
Časové okno: 1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 23 h, and 23 h 50 min related to evening dose after 4 weeks
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Response was defined as change from baseline.
Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit.
Trough values were defined as the mean of 2 FEV1 values performed at the planned timepoints 23h and 23h 50min related to evening trial-drug inhalation at the end of each 4 week period of randomised treatment.
Means are adjusted for treatment, period, patient and study baseline.
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1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 23 h, and 23 h 50 min related to evening dose after 4 weeks
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Forced Vital Capacity (FVC) Area Under Curve 0-12 Hours (AUC 0-12h) Response
Časové okno: 1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h , 3 h, 4 h, 11 h 50 min related to evening dose after 4 weeks
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Response was defined as change from baseline.
Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit.
Means are adjusted for treatment, period, patient and study baseline.
FVC AUC 0-12h was calculated using the trapezoidal rule, divided by the observation time to report in litres.
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1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h , 3 h, 4 h, 11 h 50 min related to evening dose after 4 weeks
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FVC Area Under Curve 12-24 Hours (AUC 12-24h) Response
Časové okno: 1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks
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Response was defined as change from baseline.
Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit.
Means are adjusted for treatment, period, patient and study baseline.
FVC AUC 12-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.
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1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks
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FVC Area Under Curve 0-24 Hours (AUC 0-24h) Response
Časové okno: 1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 min, 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks
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Response was defined as change from baseline.
Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit.
Means are adjusted for treatment, period, patient and study baseline.
FVC AUC 0-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.
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1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 min, 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks
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Peak FVC Within 24 Hours Post-dose Response
Časové okno: 1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks
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Response was defined as change from baseline.
Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit.
Peak FVC within 24 hours post dose measured following the trial drug inhalation at the end of each 4 week period of randomised treatment.
Means are adjusted for treatment, period, patient and study baseline.
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1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks
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Trough FVC Response
Časové okno: 1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 23 h, and 23 h 50 min related to evening dose after 4 weeks
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Response was defined as change from baseline.
Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit.
Trough values were defined as the mean of 2 FEV1 values performed at the planned timepoints 23h and 23h 50min related to evening trial-drug inhalation at the end of each 4 week period of randomised treatment.
Means are adjusted for treatment, period, patient and study baseline.
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1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 23 h, and 23 h 50 min related to evening dose after 4 weeks
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Peak Expiratory Flow (PEF) Area Under Curve 0-12 Hours (AUC 0-12h) Response
Časové okno: 1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min related to evening dose after 4 weeks
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Response was defined as change from baseline.
Study baseline PEF was defined as the mean of the available pre-dose PEF values at the randomisation visit.
Means are adjusted for treatment, period, patient and study baseline.
PEF AUC 0-12h was calculated using the trapezoidal rule, divided by the observation time to report in litres/seconds.
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1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min related to evening dose after 4 weeks
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PEF Area Under Curve 12-24 Hours (AUC 12-24h) Response
Časové okno: 1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks
|
Response was defined as change from baseline.
Study baseline PEF was defined as the mean of the available pre-dose PEF values at the randomisation visit.
Means are adjusted for treatment, period, patient and study baseline.
PEF AUC 12-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres/seconds.
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1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks
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Peak Expiratory Flow (PEF) Area Under Curve 0-24 Hours (AUC 0-24h) Response
Časové okno: 1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks
|
Response was defined as change from baseline.
Study baseline PEF was defined as the mean of the available pre-dose PEF values at the randomisation visit.
Means are adjusted for treatment, period, patient and study baseline.
PEF AUC 0-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres/seconds.
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1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks
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Peak PEF Within 24 Hours Post-dose Response
Časové okno: 1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks
|
Response was defined as change from baseline.
Study baseline PEF was defined as the mean of the available pre-dose PEF values at the randomisation visit.
Peak PEF within 24 hours post-dose measured following the evening trial drug inhalation at the end of each 4 week period of randomised treatment.
Means are adjusted for treatment, period, patient and study baseline.
|
1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks
|
Trough PEF Response
Časové okno: 1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 23 h, and 23 h 50 min related to evening dose after 4 weeks
|
Response was defined as change from baseline.
Study baseline PEF was defined as the mean of the available pre-dose PEF values at the randomisation visit.
Trough values were defined as the mean of 2 FEV1 values performed at the planned timepoints 23h and 23h 50min related to evening trial-drug inhalation at the end of each 4 week period of randomised treatment.
Means are adjusted for treatment, period, patient and study baseline.
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1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 23 h, and 23 h 50 min related to evening dose after 4 weeks
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Mean Pre-dose Morning PEF (PEF a.m.)
Časové okno: 2-4 weeks
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PEF a.m. was measured by patients at home using the AM2+ device (overall means obtained during each period of randomised treatment excluding the data of the first 2 weeks will be compared).
Means are adjusted for treatment, period, patient and study baseline.
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2-4 weeks
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Mean Pre-dose Evening PEF (PEF p.m.)
Časové okno: 2-4 weeks
|
PEF p.m. was measured by patients at home using the AM2+ device (overall means obtained during each period of randomised treatment excluding the data of the first 2 weeks will be compared).
Means are adjusted for treatment, period, patient and study baseline.
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2-4 weeks
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PEF Daily Variability
Časové okno: 2-4 weeks
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PEF daily variability was assessed by patients at home using the AM2+ device (overall means obtained during each period of randomised treatment excluding the data of the first 2 weeks will be compared).
PEF daily variability is the absolute difference between the morning and the evening PEF value divided by the mean of these two values, expressed as a percent.
Means are adjusted for treatment, period, patient and study baseline.
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2-4 weeks
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Mean Pre-dose Morning FEV1 (FEV1 a.m.)
Časové okno: 2-4 weeks
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FEV1 a.m. was measured by patients at home using the AM2+ device (overall means obtained during each period of randomised treatment excluding the data of the first 2 weeks will be compared).
Means are adjusted for treatment, period, patient and study baseline.
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2-4 weeks
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Mean Pre-dose Evening FEV1 (FEV1 p.m.)
Časové okno: 2-4 weeks
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FEV1 p.m. was measured by patients at home using the AM2+ device (overall means obtained during each period of randomised treatment excluding the data of the first 2 weeks will be compared).
Means are adjusted for treatment, period, patient and study baseline.
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2-4 weeks
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Mean Number of Puffs of Rescue Medication During the Whole Day
Časové okno: 2-4 weeks
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Mean of daily use of salbutamol (albuterol) rescue medication as needed during the entire study period.
Assessed by patients at home using the AM2+ device (overall means obtained during each period of randomised treatment excluding the data of the first 2 weeks will be compared).
Means are adjusted for treatment, period, patient and study baseline.
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2-4 weeks
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Percentage of Asthma Symptom Free Days
Časové okno: 2-4 weeks
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Percentage of asthma-symptom free days after the first 2 weeks of each treatment period was calculated as the number of symptom-free days divided by the number of days on treatment multiplied by 100.
A symptom-free day was defined as a day in which no asthma symptoms were recorded, no rescue medication was recorded, activities during the day were not at all limited due to asthma, no shortness of breath during the day was recorded, no wheezing or coughing during the day and no night-time awakenings due to asthma were recorded.
Assessed by patients at home using the AM2+ device.
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2-4 weeks
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Number of Patients Categorized by Highest Number of Night Time Awakenings (Overall)
Časové okno: 2-4 weeks
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Assessed by patients at home using the AM2+ device after the first 2 weeks of each period of randomised treatment.
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2-4 weeks
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Number of Patients Categorized by Worst Asthma Daytime Symptoms (Overall)
Časové okno: 2-4 weeks
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Assessed by patients at home using the AM2+ device after the first 2 weeks of each period of randomised treatment.
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2-4 weeks
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Number of Patients Categorized by Worst Asthma Nighttime Symptoms (Overall)
Časové okno: 2-4 weeks
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Assessed by patients at home using the AM2+ device after the first 2 weeks of each period of randomised treatment.
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2-4 weeks
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Total Asthma Quality of Life Questionnaire (AQLQ(s)) Score
Časové okno: 4 weeks
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Total score from the Standardised Asthma Quality of Life Questionnaire (AQLQ (s)) at the end of each 4 week treatment period.
The AQLQ(s) contains 32 questions, each question has a 7 point scale from 1 (highest intensity) till 7 (no symptoms).
Total score was defined as the sum of all items divided by the number of items.
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4 weeks
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Total Asthma Control Questionnaire (ACQ) Score
Časové okno: 4 weeks
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Control of asthma as assessed by the ACQ at the end of each 4-week treatment period.The ACQ contains 7 questions, each question has a 7 point scale from 0 (no symptoms) till 6 (highest intensity).
Total score was defined as the sum of all items divided by the number of items.
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4 weeks
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Potassium 1 Hour Pre-dose
Časové okno: 4 weeks
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Effect on potassium evaluated 1 hour pre-dose.
Analysis is based on the log of the potassium values.
For the geometric means, the results were back-transformed to the original scale.
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4 weeks
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Potassium 1 Hour Post-dose
Časové okno: 4 weeks
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Effect on potassium evaluated 1 hour post-dose.
Analysis is based on the log of the potassium values.
For the geometric means, the results were back-transformed to the original scale.
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4 weeks
|
Potassium 3 Hours Post-dose
Časové okno: 4 weeks
|
Effect on potassium evaluated 3 hours post-dose.
Analysis is based on the log of the potassium values.
For the geometric means, the results were back-transformed to the original scale.
|
4 weeks
|
Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG
Časové okno: 4 weeks
|
Clinical relevant abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG.
New abnormal findings or worsening of baseline conditions were reported as Adverse Events.
|
4 weeks
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
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
1. února 2010
Primární dokončení (Aktuální)
1. ledna 2011
Dokončení studie (Aktuální)
1. ledna 2011
Termíny zápisu do studia
První předloženo
13. listopadu 2009
První předloženo, které splnilo kritéria kontroly kvality
13. listopadu 2009
První zveřejněno (Odhad)
16. listopadu 2009
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
27. června 2014
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
17. června 2014
Naposledy ověřeno
1. května 2014
Více informací
Termíny související s touto studií
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
- Agonisté adrenergních beta-2 receptorů
- Adrenergní beta-agonisté
- Olodaterol
- Formoterol fumarát
Další identifikační čísla studie
- 1222.27
- 2009-013395-48 (Číslo EudraCT: EudraCT)
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 Olodaterol (BI 1744) low
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Boehringer IngelheimDokončenoPlicní onemocnění, chronická obstrukčníRakousko, Belgie, Kanada, Německo, Ruská Federace
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Boehringer IngelheimDokončeno
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Boehringer IngelheimDokončeno
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Boehringer IngelheimDokončenoAstmaSpojené státy, Kanada, Francie, Německo