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A Study of the Safety and Efficacy of 4 Doses of BI 1744 CL Delivered Via the Respimat in Patients With Asthma.

2014년 6월 17일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

198

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 독일
      • Berlin, 독일
        • 1222.27.49003 Boehringer Ingelheim Investigational Site
      • Berlin, 독일
        • 1222.27.49004 Boehringer Ingelheim Investigational Site
      • Berlin, 독일
        • 1222.27.49009 Boehringer Ingelheim Investigational Site
      • Frankfurt, 독일
        • 1222.27.49011 Boehringer Ingelheim Investigational Site
      • Hannover, 독일
        • 1222.27.49008 Boehringer Ingelheim Investigational Site
      • Lübeck, 독일
        • 1222.27.49002 Boehringer Ingelheim Investigational Site
      • Rüdersdorf, 독일
        • 1222.27.49007 Boehringer Ingelheim Investigational Site
      • Wiesbaden, 독일
        • 1222.27.49006 Boehringer Ingelheim Investigational Site
      • Wiesloch, 독일
        • 1222.27.49010 Boehringer Ingelheim Investigational Site
  • 루마니아
      • Bucharest, 루마니아
        • 1222.27.40002 Boehringer Ingelheim Investigational Site
      • Bucharest, 루마니아
        • 1222.27.40003 Boehringer Ingelheim Investigational Site
  • 슬로바키아
      • Bardejov, 슬로바키아
        • 1222.27.42101 Boehringer Ingelheim Investigational Site
      • Lucenec, 슬로바키아
        • 1222.27.42103 Boehringer Ingelheim Investigational Site
      • Martin, 슬로바키아
        • 1222.27.42104 Boehringer Ingelheim Investigational Site
      • Spisska Nova Ves, 슬로바키아
        • 1222.27.42102 Boehringer Ingelheim Investigational Site
  • 슬로베니아
      • Golnik, 슬로베니아
        • 1222.27.38601 Boehringer Ingelheim Investigational Site
      • Hoce, 슬로베니아
        • 1222.27.38603 Boehringer Ingelheim Investigational Site
      • Kamnik, 슬로베니아
        • 1222.27.38605 Boehringer Ingelheim Investigational Site
      • Topolsica, 슬로베니아
        • 1222.27.38604 Boehringer Ingelheim Investigational Site
  • 오스트리아
      • Linz, 오스트리아
        • 1222.27.43002 Boehringer Ingelheim Investigational Site
      • Schlüsslberg, 오스트리아
        • 1222.27.43004 Boehringer Ingelheim Investigational Site
      • Thalheim bei Wels, 오스트리아
        • 1222.27.43001 Boehringer Ingelheim Investigational Site
      • Wien, 오스트리아
        • 1222.27.43003 Boehringer Ingelheim Investigational Site
  • 폴란드
      • Lodz, 폴란드
        • 1222.27.48001 Boehringer Ingelheim Investigational Site
      • Lodz, 폴란드
        • 1222.27.48002 Boehringer Ingelheim Investigational Site
      • Poznan, 폴란드
        • 1222.27.48003 Boehringer Ingelheim Investigational Site
      • Proszowice, 폴란드
        • 1222.27.48004 Boehringer Ingelheim Investigational Site

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion criteria:

  1. 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.
  2. Male or female patients, aged between 18 and 70 years of age, diurnally active
  3. 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.
  4. Pre-bronchodilator FEV1 between 60% predicted and 90% predicted at Visit 1.
  5. Increase in FEV1 greater or equal to 12% and 200 ml 15 minutes after 400mcg salbutamol (albuterol) at Visit 1.
  6. 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).
  7. All patients must be symptomatic.

Exclusion criteria:

  1. 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
  2. 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
  3. 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

  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 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.

  5. 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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 크로스오버 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
위약 비교기: 위약
Respimat 흡입기에서 1일 1회 흡입하는 Olodaterol(BI 1744) 위약 및/또는 Aerolizer 흡입기에서 1일 2회 흡입하는 Formoterol 위약
의약품: Placebo
Determine efficacy and safety of Placebo inhaled once daily from the Respimat inhaler and/or twice daily from the Aerolizer inhaler
실험적: Olodaterol (BI 1744) low
Low dose inhaled orally once daily from the Respimat inhaler
의약품: Olodaterol (BI 1744) low
Determine efficacy and safety of 4 different doses of Olodaterol (BI 1744) inhaled once daily via the Respimat
실험적: Olodaterol (BI 1744) very low
Very low dose inhaled orally once daily from the Respimat inhaler
의약품: Olodaterol (BI 1744) very low
Determination of efficacy in 4 different doses of Olodaterol (BI 1744) inhaled once daily via the Respimat
실험적: Olodaterol (BI 1744) medium
Medium dose inhaled orally once daily from the Respimat inhaler
의약품: Olodaterol (BI 1744) medium
Determination of efficacy in 4 different doses of Olodaterol (BI 1744) inhaled once daily via the Respimat
실험적: Olodaterol (BI 1744) high
High dose inhaled orally once daily from the Respimat inhaler
의약품: Olodaterol (BI 1744) high
Determine efficacy and safety in 4 different doses of Olodaterol (BI 1744) inhaled once daily via the Respimat
활성 비교기: Formoterol 12 mcg
12mcg inhaled twice daily from the Aerolizer inhaler
의약품: Formoterol 12 mcg
Determine efficacy and safety of 12 mcg Formoterol dose inhaled orally twice daily from the Aerolizer in comparison to other treatment groups

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-24 Hours (AUC 0-24h) Response at the End of Each Treatment Period
기간: 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
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.
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

2차 결과 측정

결과 측정
측정값 설명
기간
FEV1 Area Under Curve 0-12 h (AUC 0-12h) Response at the End of Each Treatment Period
기간: 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
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.
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
FEV1 Area Under Curve 12-24 h (AUC 12-24h) Response at the End of Each Treatment Period
기간: 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 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.
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
Peak FEV1 Within 24 Hours Post-dose Response
기간: 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 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.
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 FEV1 Response
기간: 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 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.
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
Forced Vital Capacity (FVC) Area Under Curve 0-12 Hours (AUC 0-12h) Response
기간: 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
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.
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
FVC Area Under Curve 12-24 Hours (AUC 12-24h) Response
기간: 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 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.
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
FVC Area Under Curve 0-24 Hours (AUC 0-24h) Response
기간: 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
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.
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
Peak FVC Within 24 Hours Post-dose Response
기간: 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 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.
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 FVC Response
기간: 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 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.
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
Peak Expiratory Flow (PEF) Area Under Curve 0-12 Hours (AUC 0-12h) Response
기간: 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
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.
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
PEF Area Under Curve 12-24 Hours (AUC 12-24h) Response
기간: 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.
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
Peak Expiratory Flow (PEF) Area Under Curve 0-24 Hours (AUC 0-24h) Response
기간: 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.
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
Peak PEF Within 24 Hours Post-dose Response
기간: 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
기간: 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.
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
Mean Pre-dose Morning PEF (PEF a.m.)
기간: 2-4 weeks
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.
2-4 weeks
Mean Pre-dose Evening PEF (PEF p.m.)
기간: 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.
2-4 weeks
PEF Daily Variability
기간: 2-4 weeks
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.
2-4 weeks
Mean Pre-dose Morning FEV1 (FEV1 a.m.)
기간: 2-4 weeks
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.
2-4 weeks
Mean Pre-dose Evening FEV1 (FEV1 p.m.)
기간: 2-4 weeks
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.
2-4 weeks
Mean Number of Puffs of Rescue Medication During the Whole Day
기간: 2-4 weeks
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.
2-4 weeks
Percentage of Asthma Symptom Free Days
기간: 2-4 weeks
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.
2-4 weeks
Number of Patients Categorized by Highest Number of Night Time Awakenings (Overall)
기간: 2-4 weeks
Assessed by patients at home using the AM2+ device after the first 2 weeks of each period of randomised treatment.
2-4 weeks
Number of Patients Categorized by Worst Asthma Daytime Symptoms (Overall)
기간: 2-4 weeks
Assessed by patients at home using the AM2+ device after the first 2 weeks of each period of randomised treatment.
2-4 weeks
Number of Patients Categorized by Worst Asthma Nighttime Symptoms (Overall)
기간: 2-4 weeks
Assessed by patients at home using the AM2+ device after the first 2 weeks of each period of randomised treatment.
2-4 weeks
Total Asthma Quality of Life Questionnaire (AQLQ(s)) Score
기간: 4 weeks
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.
4 weeks
Total Asthma Control Questionnaire (ACQ) Score
기간: 4 weeks
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.
4 weeks
Potassium 1 Hour Pre-dose
기간: 4 weeks
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.
4 weeks
Potassium 1 Hour Post-dose
기간: 4 weeks
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.
4 weeks
Potassium 3 Hours Post-dose
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Boehringer Ingelheim

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2010년 2월 1일

기본 완료 (실제)

2011년 1월 1일

연구 완료 (실제)

2011년 1월 1일

연구 등록 날짜

최초 제출

2009년 11월 13일

QC 기준을 충족하는 최초 제출

2009년 11월 13일

처음 게시됨 (추정)

2009년 11월 16일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2014년 6월 27일

QC 기준을 충족하는 마지막 업데이트 제출

2014년 6월 17일

마지막으로 확인됨

2014년 5월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 1222.27
  • 2009-013395-48 (EudraCT 번호: EudraCT)

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

Olodaterol (BI 1744) low에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in United Kingdom

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다