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Efficacy and Safety of 4 Weeks Treatment With Inhaled BI 1744 CL in Japanese Patients With COPD

17 de junio de 2014 actualizado por: Boehringer Ingelheim

Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of 4 Weeks of Once Daily Treatment of Orally Inhaled BI 1744 CL Delivered by the Respimat Inhaler in Japanese Patients With COPD

The primary objective of this study is to determine the optimum dose(s) of BI 1744 CL inhalation solution delivered by the Respimat inhaler once daily for 4 weeks in Japanese patients with chronic obstructive pulmonary disease (COPD). The selection of the optimum dose(s) will be based on bronchodilator efficacy, safety evaluations and pharmacokinetic evaluations.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

328

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Japón
      • Asahikawa, Hokkaido, Japón
        • 1222.22.048 Boehringer Ingelheim Investigational Site
      • Bunkyo-ku, Tokyo, Japón
        • 1222.22.044 Boehringer Ingelheim Investigational Site
      • Chiba, Chiba, Japón
        • 1222.22.008 Boehringer Ingelheim Investigational Site
      • Fukuoka, Fukuoka, Japón
        • 1222.22.002 Boehringer Ingelheim Investigational Site
      • Fukuoka, Fukuoka, Japón
        • 1222.22.041 Boehringer Ingelheim Investigational Site
      • Himeji, Hyogo, Japón
        • 1222.22.027 Boehringer Ingelheim Investigational Site
      • Himeji, Hyogo, Japón
        • 1222.22.028 Boehringer Ingelheim Investigational Site
      • Hiroshima, Hiroshima, Japón
        • 1222.22.018 Boehringer Ingelheim Investigational Site
      • Hitachi, Ibaraki, Japón
        • 1222.22.021 Boehringer Ingelheim Investigational Site
      • Inashiki-gun, Ibaraki, Japón
        • 1222.22.010 Boehringer Ingelheim Investigational Site
      • Itabashi-ku, Tokyo, Japón
        • 1222.22.012 Boehringer Ingelheim Investigational Site
      • Kamogawa, Chiba, Japón
        • 1222.22.009 Boehringer Ingelheim Investigational Site
      • Kawasaki, Kanagawa, Japón
        • 1222.22.023 Boehringer Ingelheim Investigational Site
      • Kawasaki, Kanagawa, Japón
        • 1222.22.025 Boehringer Ingelheim Investigational Site
      • Kishiwada, Osaka, Japón
        • 1222.22.017 Boehringer Ingelheim Investigational Site
      • Kitakyusyu, Fukuoka, Japón
        • 1222.22.004 Boehringer Ingelheim Investigational Site
      • Koga, Fukuoka, Japón
        • 1222.22.020 Boehringer Ingelheim Investigational Site
      • Komaki, Aichi, Japón
        • 1222.22.014 Boehringer Ingelheim Investigational Site
      • Kumamoto, Kumamoto, Japón
        • 1222.22.032 Boehringer Ingelheim Investigational Site
      • Kurume, Fukuoka, Japón
        • 1222.22.005 Boehringer Ingelheim Investigational Site
      • Kurume, Fukuoka, Japón
        • 1222.22.029 Boehringer Ingelheim Investigational Site
      • Kyoto, Kyoto, Japón
        • 1222.22.033 Boehringer Ingelheim Investigational Site
      • Kyoto, Kyoto, Japón
        • 1222.22.050 Boehringer Ingelheim Investigational Site
      • Matsumoto, Nagano, Japón
        • 1222.22.022 Boehringer Ingelheim Investigational Site
      • Nagoya, Aichi, Japón
        • 1222.22.015 Boehringer Ingelheim Investigational Site
      • Nagoya, Aichi, Japón
        • 1222.22.043 Boehringer Ingelheim Investigational Site
      • Naka-gun, Ibaraki, Japón
        • 1222.22.001 Boehringer Ingelheim Investigational Site
      • Niigata, Niigata, Japón
        • 1222.22.007 Boehringer Ingelheim Investigational Site
      • Obihiro, Hokkaido, Japón
        • 1222.22.040 Boehringer Ingelheim Investigational Site
      • Okinawa, Okinawa, Japón
        • 1222.22.042 Boehringer Ingelheim Investigational Site
      • Osaka, Osaka, Japón
        • 1222.22.034 Boehringer Ingelheim Investigational Site
      • Osaka, Osaka, Japón
        • 1222.22.038 Boehringer Ingelheim Investigational Site
      • Osaka, Osaka, Japón
        • 1222.22.049 Boehringer Ingelheim Investigational Site
      • Osaka-sayama, Osaka, Japón
        • 1222.22.045 Boehringer Ingelheim Investigational Site
      • Sakai, Oasaka, Japón
        • 1222.22.019 Boehringer Ingelheim Investigational Site
      • Sapporo, Hokkaido, Japón
        • 1222.22.006 Boehringer Ingelheim Investigational Site
      • Sashima-gun, Ibaraki, Japón
        • 1222.22.051 Boehringer Ingelheim Investigational Site
      • Sendai, Miyagi, Japón
        • 1222.22.031 Boehringer Ingelheim Investigational Site
      • Seto, Aichi, Japón
        • 1222.22.013 Boehringer Ingelheim Investigational Site
      • Shibata-gun, Miyagi, Japón
        • 1222.22.024 Boehringer Ingelheim Investigational Site
      • Takarazuka, Hyogo, Japón
        • 1222.22.003 Boehringer Ingelheim Investigational Site
      • Tsukuba, Ibaraki, Japón
        • 1222.22.026 Boehringer Ingelheim Investigational Site
      • Ube, Yamaguchi, Japón
        • 1222.22.030 Boehringer Ingelheim Investigational Site
      • Uji, Kyoto, Japón
        • 1222.22.037 Boehringer Ingelheim Investigational Site
      • Wakayama, Wakayama, Japón
        • 1222.22.047 Boehringer Ingelheim Investigational Site
      • Yamagata, Yamagata, Japón
        • 1222.22.016 Boehringer Ingelheim Investigational Site
      • Yao, Osaka, Japón
        • 1222.22.036 Boehringer Ingelheim Investigational Site
      • Yokohama, Kanagawa, Japón
        • 1222.22.011 Boehringer Ingelheim Investigational Site

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

40 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  1. All patients must sign an informed consent consistent with GCP guidelines prior to participation in the trial.
  2. All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria: Patients must have relatively stable, moderate to severe airway obstruction with a post-bronchodilator FEV1 >=30% of predicted normal and <80% of predicted normal and a post-bronchodilator FEV1/FVC <70% at Visit 1
  3. Male or female patients, 40 years of age or older
  4. Patients must be current or ex-smokers with a smoking history of more than 10 pack-years. Pack-Years = [Number of cigarettes/day/20] - years of smoking Patients who have never smoked cigarettes must be excluded.
  5. Patients must be able to perform technically acceptable pulmonary function tests (both supervised and unsupervised) and PEFR measurements, and must be able to record a patient diary during the study period as required in the protocol.
  6. Patients must be able to inhale medication in a competent manner from the Respimat inhaler and from a MDI.

Exclusion Criteria:

  1. Patients with a significant disease other than COPD; 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
  2. Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis; all patients with an AST >80 IU/L, ALT >80 IU/L, bilirubin >1.5 x ULN or creatinine >1.5 x ULN will be excluded regardless of clinical condition (a repeat laboratory evaluation will not be conducted in these patients)
  3. Patients with a history of asthma or a total blood eosinophil count >=600/mm3. A repeat eosinophil count will not be conducted in these patients

  4. 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 (e.g. repeated demonstration of a QTc interval >450 ms) as recommended by ICH E14. For patients who have a QTc interval between 450 ms and 500 ms, as judged by site personnel, there will be a confirmatory reading by centralized evaluation institute. If the confirmatory reading is still greater than 450 ms, patient will be excluded. Patients with a QTc interval >=500 ms will immediately be excluded from the study.
    • 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.

  5. Patients with any of the following conditions:

    • a history of myocardial infarction within 1 year
    • a diagnosis of clinically relevant cardiac arrhythmia
    • known active tuberculosis
    • a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last 5 years (patients with treated basal cell carcinoma are allowed)
    • a history of life-threatening pulmonary obstruction
    • a history of cystic fibrosis
    • clinically evident bronchiectasis
    • a history of significant alcohol or drug abuse
  6. Patients who have undergone thoracotomy with pulmonary resection (patients with a history of thoracotomy for other reasons should be evaluated as per exclusion criterion No. 1)

  7. Patients being treated with any of the following concomitant medications:

    • medications that prolong the QT/QTc interval
    • oral beta-adrenergics and beta-adrenergics patchs
    • beta-blockers (topical beta-blockers for ocular conditions are allowed)
    • oral corticosteroid medication at unstable doses (i.e. less than 6 weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day.
  8. Patients who regularly use daytime oxygen therapy for more than 1 hour per day and in the investigator's opinion will be unable to abstain from the use of oxygen therapy during clinic visits
  9. Patients who have completed a pulmonary rehabilitation program in the 6 weeks prior to the screening visit (Visit 1) or patients who are currently in a pulmonary rehabilitation program
  10. Patients who have taken an investigational drug within 1 month or 6 half lives (whichever is greater) prior to screening visit
  11. Patients with known hypersensitivity to beta-adrenergics drugs, BAC, EDTA or any other component of the Respimat inhalation solution delivery system
  12. Pregnant or suspect of pregnant or women who are willing to become pregnant during the study period or nursing women
  13. Patients who have previously been participated in this study or are currently participating in another study
  14. Patients who are unable to comply with pulmonary medication restrictions prior to randomisation
  15. The randomization of patients with any respiratory infection or COPD exacerbation in the 6 weeks prior to the screening visit or during the screening period should be postponed. Patients may be randomised 6 weeks following recovery from the infection or exacerbation

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: BI 1744 CL 5 µg
2 puffs of 2.5 µg/actuation
Droga: BI 1744 CL 5 µg
2 puffs of 2.5 µg/actuation delivered by the Respimat® inhaler
Experimental: BI 1744 CL 10 µg
2 puffs of 5 µg/actuation
Droga: BI 1744 CL 10 µg
2 puffs of 5 µg/actuation delivered by Respimat®
Comparador de placebos: Placebo
2 puffs
Droga: Placebo
2 puffs delivered by the Respimat® inhaler
Experimental: BI 1744 CL 2 µg
2 puffs of 1 µg/actuation
Droga: BI 1744 CL 2 µg
2 puffs of 1 µg/actuation delivered by the Respimat® inhaler

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Trough FEV1 Response at Week 4
Periodo de tiempo: baseline and after 4 weeks treatment
The change from baseline in trough FEV1 after 4 weeks of treatment. Trough FEV1 is defined as the mean of the two FEV1 values (performed at -1 hour and -10 minutes prior to next test-drug inhalation) at the end of the dosing interval, 24 hours post-drug administration. Trough FEV1 response is defined as the change from baseline . Baseline trough FEV1 is the mean of the two pre-treatment FEV1 values measured at Visit 2 prior to administration of the first dose of study medication.
baseline and after 4 weeks treatment

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Trough FEV1 Response at Week 2
Periodo de tiempo: baseline and after 2 weeks treatment
Trough FEV1 is defined as the mean of the two FEV1 values (performed at -1 hour and -10 minutes prior to next test-drug inhalation) at the end of the dosing interval, 24 hours post-drug administration. Trough FEV1 response is defined as the change from baseline in trough FEV1. Baseline trough FEV1 is the mean of the two pre-treatment FEV1 values measured at Visit 2 prior to administration of the first dose of study medication
baseline and after 2 weeks treatment
FEV1 AUC(0-3) Response at 4 Weeks
Periodo de tiempo: baseline and after 4 weeks treatment

The change from baseline in FEV1 AUC(0-3) after 4 weeks of treatment. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in liters.

Due to normalization the unit is liters.
baseline and after 4 weeks treatment
FEV1 Peak(0-3) Response at 4 Weeks
Periodo de tiempo: baseline and after 4 weeks treatment
The change from baseline in FEV1 peak(0-3) after 4 weeks of treatment.
baseline and after 4 weeks treatment
Trough FVC Response at Week 4
Periodo de tiempo: baseline and after 4 weeks treatment
The change from baseline in Trough FVC after 4 weeks of treatment
baseline and after 4 weeks treatment
FVC AUC(0-3) Response
Periodo de tiempo: baseline and after 4 weeks treatment

The change from baseline in FVC AUC(0-3) response after 4 weeks of treatment. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in liters.

Due to normalization the unit is liters.
baseline and after 4 weeks treatment
FVC Peak(0-3) Response
Periodo de tiempo: baseline and after 4 weeks treatment
The change from baseline in FVC peak(0-3) response after 4 weeks of treatment.
baseline and after 4 weeks treatment
Forced Expiratory Volume in 1 Second (FEV1) (Unsupervised) Area Under Curve 0-6h (AUC 0-6h) Response After 4 Weeks
Periodo de tiempo: baseline and after 4weeks treatment

Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Means are adjusted using a model with treatment (trt), baseline as fixed effects and centre as random effect.

FEV1 AUC 0-6h was calculated from 0-6 hours post-dose using the trapezoidal rule, divided by the observation time (6h) to report in liters.
baseline and after 4weeks treatment
Forced Expiratory Volume in 1 Second (FEV1) (Unsupervised) Area Under Curve 6-12 h (AUC 6-12h) Response After 4 Weeks
Periodo de tiempo: Baseline and after 4weeks treatment

Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Means are adjusted using a model with treatment (trt), baseline as fixed effects and centre as random effect.

FEV1 AUC 6-12h was calculated from 6-12 hours post-dose using the trapezoidal rule, divided by the observation time (6h) to report in liters.
Baseline and after 4weeks treatment
Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) After 4 Weeks
Periodo de tiempo: Week 4

PEFR measurements were recorded by means of a patient diary on a daily basis. This diary was used to record the twice daily PEFs,

Morning measurements were performed immediately upon arising before administration of trial and/or rescue medication.The highest of three readings for each measurement were recorded.
Week 4
Weekly Mean Evening PEFR After 4 Weeks
Periodo de tiempo: Week 4

PEFR measurements were recorded by means of a patient diary on a daily basis. This diary was used to record the twice daily PEFs,

Evening measurements were performed at bedtime.The highest of three readings for each measurement were recorded.
Week 4
Weekly Mean Number of Occasions of Rescue Therapy After 4 Weeks
Periodo de tiempo: Week 4
Weekly mean number of occasions of rescue therapy used per day (PRN salbutamol )
Week 4
Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis, ECG and Physical Examination
Periodo de tiempo: 4 weeks
Clinical relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis, ECG and Physical examination. New abnormal findings or worsenings of baseline conditions were reported as Adverse Events related to treatment (cardiac disorders and investigations).
4 weeks
Difference From Baseline in Potassium
Periodo de tiempo: Baseline, Week 4
Difference from baseline in Potassium (normalized values). Normalization means that the values from different laboratories are transformed in such a way that they are directly comparable.
Baseline, Week 4
Cmax (Maximum Measured Concentration of the Analyte in Plasma)
Periodo de tiempo: after first inhalated administration
Cmax only calculated if >1/3 of the patients have available pharmacokinetic parameters,thus not applicable for the Olodaterol 2 mcg
after first inhalated administration
Cmax,ss (Maximum Measured Concentration of the Analyte in Plasma at Steady State)
Periodo de tiempo: visit at week 4
Cmax,ss only calculated if >1/3 of the patients have available pharmacokinetic parameters, thus not applicable for the Olodaterol 2 mcg
visit at week 4
AUC0-1
Periodo de tiempo: after first inhalated administration
Area under the concentration curve from 0 to 1 hour using trapezoid rule, only calculated if >1/3 of the patients have available pharmacokinetic parameters,thus not applicable for Olodaterol 2mcg group
after first inhalated administration
AUC0-1,ss
Periodo de tiempo: visit at week 4
Area under the concentration curve from 0 to 1 hour at steady state using trapezoid rule, only calculated if >1/3 of the patients have available pharmacokinetic parameters, thus not applicable for Olodaterol 2mcg group
visit at week 4

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Boehringer Ingelheim

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de enero de 2009

Finalización primaria (Actual)

1 de marzo de 2010

Fechas de registro del estudio

Enviado por primera vez

15 de enero de 2009

Primero enviado que cumplió con los criterios de control de calidad

15 de enero de 2009

Publicado por primera vez (Estimar)

16 de enero de 2009

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

27 de junio de 2014

Última actualización enviada que cumplió con los criterios de control de calidad

17 de junio de 2014

Última verificación

1 de mayo de 2014

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 1222.22

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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