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Efficacy and Safety of Tiotropium and Salmeterol in Moderate Persistent Asthma Patients Homozygous for B16-Arg/Arg

2013年11月27日 更新者：Boehringer Ingelheim

A 16-week Randomised, Placebo-controlled, Double-blind, Double-dummy, Parallel-group Study Comparing the Efficacy and Safety of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler (2 Actuations of 2.5 Mcg Once Daily) With That of Salmeterol From the Hydrofluoroalkane Metered Dose Inhaler (2 Actuations of 25 Mcg Twice Daily) in Moderate Persistent Asthma Patients With the B16-Arg/Arg Genotype

This is a 16 week multicentre, multinational, randomised, double-blind, double-dummy, placebo-controlled, parallel group study to evaluate the long-term efficacy and safety of tiotropium compared to salmeterol in moderate persistent asthmatic (GINA step 3) patients homozygous for arginine at the 16th amino acid position of the beta-adrenergic receptor (ADRB2). Following an initial 4-week run-in period on salmeterol MDI patients will be randomised into the 16 week double-blind treatment period in which they receive either tiotropium once daily administered from the Respimat inhaler or salmeterol twice daily administered from the hydrofluoro-alkane Metered Dose Inhaler (MDI), or placebo twice daily. After the 16 week treatment period all patients will receive salmeterol MDI twice daily for four weeks.

The patients perform daily morning and evening peak flow (PEF) and Forced Expiratory Volume in the First Second (FEV1) measurements with an electronic peak flow meter throughout the study. Daily data on asthma control and use of rescue medication are recorded using an electronic diary included in the electronic peak flow meter. On study visits the Mini-Asthma Quality of Life Questionnaire (Elizabeth Juniper) is administered, pulse and blood pressure and pre-dose pulmonary function testing (FEV1 and Forced Vital Capacity) are performed.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

388

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 丹麦
      • Aalborg、丹麦
        • 205.342.45003 Boehringer Ingelheim Investigational Site
      • Hvidovre、丹麦
        • 205.342.45001 Boehringer Ingelheim Investigational Site
      • Kobenhavn NV、丹麦
        • 205.342.45002 Boehringer Ingelheim Investigational Site
      • Odense C、丹麦
        • 205.342.45004 Boehringer Ingelheim Investigational Site
  • 俄罗斯联邦
      • Moscow、俄罗斯联邦
        • 205.342.07001 Boehringer Ingelheim Investigational Site
      • Moscow、俄罗斯联邦
        • 205.342.07002 Boehringer Ingelheim Investigational Site
      • Moscow、俄罗斯联邦
        • 205.342.07003 Boehringer Ingelheim Investigational Site
      • Moscow、俄罗斯联邦
        • 205.342.07004 Boehringer Ingelheim Investigational Site
      • Moscow、俄罗斯联邦
        • 205.342.07005 Boehringer Ingelheim Investigational Site
      • St. Petersburg、俄罗斯联邦
        • 205.342.07006 Boehringer Ingelheim Investigational Site
      • St. Petersburg、俄罗斯联邦
        • 205.342.07007 Boehringer Ingelheim Investigational Site
      • St. Petersburg、俄罗斯联邦
        • 205.342.07008 Boehringer Ingelheim Investigational Site
  • 南非
      • Bellville、南非
        • 205.342.27002 Boehringer Ingelheim Investigational Site
      • Bloemfontein、南非
        • 205.342.27008 Boehringer Ingelheim Investigational Site
      • Cape Town、南非
        • 205.342.27001 Boehringer Ingelheim Investigational Site
      • Cape Town、南非
        • 205.342.27004 Boehringer Ingelheim Investigational Site
      • Centurion、南非
        • 205.342.27006 Boehringer Ingelheim Investigational Site
      • Durban、南非
        • 205.342.27003 Boehringer Ingelheim Investigational Site
      • George、南非
        • 205.342.27007 Boehringer Ingelheim Investigational Site
      • Pretoria、南非
        • 205.342.27005 Boehringer Ingelheim Investigational Site
  • 奥地利
      • Graz、奥地利
        • 205.342.43002 Boehringer Ingelheim Investigational Site
      • Trofaiach、奥地利
        • 205.342.43004 Boehringer Ingelheim Investigational Site
      • Wels、奥地利
        • 205.342.43003 Boehringer Ingelheim Investigational Site
      • Wien、奥地利
        • 205.342.43001 Boehringer Ingelheim Investigational Site
      • Wien、奥地利
        • 205.342.43005 Boehringer Ingelheim Investigational Site
      • Wien、奥地利
        • 205.342.43006 Boehringer Ingelheim Investigational Site
      • Wien、奥地利
        • 205.342.43007 Boehringer Ingelheim Investigational Site
  • 希腊
      • Athens、希腊
        • 205.342.30001 Boehringer Ingelheim Investigational Site
      • Athens、希腊
        • 205.342.30002 Boehringer Ingelheim Investigational Site
      • Heraklion、希腊
        • 205.342.30005 Boehringer Ingelheim Investigational Site
      • Kavala、希腊
        • 205.342.30006 Boehringer Ingelheim Investigational Site
      • Larisa、希腊
        • 205.342.30004 Boehringer Ingelheim Investigational Site
      • Thessaloniki、希腊
        • 205.342.30003 Boehringer Ingelheim Investigational Site
  • 德国
      • Beelitz-Heilstätten、德国
        • 205.342.49016 Boehringer Ingelheim Investigational Site
      • Berlin、德国
        • 205.342.49004 Boehringer Ingelheim Investigational Site
      • Berlin、德国
        • 205.342.49006 Boehringer Ingelheim Investigational Site
      • Berlin、德国
        • 205.342.49013 Boehringer Ingelheim Investigational Site
      • Bruchsal、德国
        • 205.342.49003 Boehringer Ingelheim Investigational Site
      • Frankfurt/Main、德国
        • 205.342.49011 Boehringer Ingelheim Investigational Site
      • Kassel、德国
        • 205.342.49007 Boehringer Ingelheim Investigational Site
      • Köln、德国
        • 205.342.49009 Boehringer Ingelheim Investigational Site
      • Mainz、德国
        • 205.342.49010 Boehringer Ingelheim Investigational Site
      • Minden、德国
        • 205.342.49008 Boehringer Ingelheim Investigational Site
      • Neuruppin、德国
        • 205.342.49015 Boehringer Ingelheim Investigational Site
      • Rathenow、德国
        • 205.342.49012 Boehringer Ingelheim Investigational Site
      • Rüdersdorf、德国
        • 205.342.49005 Boehringer Ingelheim Investigational Site
      • Weinheim、德国
        • 205.342.49002 Boehringer Ingelheim Investigational Site
  • 意大利
      • Ferrara、意大利
        • 205.342.39003 Azienda Ospedaliera " S. Anna"
      • Firenze、意大利
        • 205.342.39006 Azienda Ospedaliera Universitaria Careggi
      • Genova、意大利
        • 205.342.39005 Ospedale San Martino
      • Modena、意大利
        • 205.342.39002 Università di Modena e Reggio Emilia
      • Orbassano (to)、意大利
        • 205.342.39010 Boehringer Ingelheim Investigational Site
      • Pavia、意大利
        • 205.342.39007 Policlinico San Matteo
      • Pisa、意大利
        • 205.342.39001 Ospedale di Cisanello
      • Sesto San Giovanni (mi)、意大利
        • 205.342.39009 Boehringer Ingelheim Investigational Site
  • 斯洛伐克
      • Banska Bystrica、斯洛伐克
        • 205.342.42101 Boehringer Ingelheim Investigational Site
      • Bratislava、斯洛伐克
        • 205.342.42102 Boehringer Ingelheim Investigational Site
      • Bratislava、斯洛伐克
        • 205.342.42104 Boehringer Ingelheim Investigational Site
      • Bratislava、斯洛伐克
        • 205.342.42105 Boehringer Ingelheim Investigational Site
      • Bratislava、斯洛伐克
        • 205.342.42107 Boehringer Ingelheim Investigational Site
      • Kosice、斯洛伐克
        • 205.342.42103 Boehringer Ingelheim Investigational Site
      • Trencin、斯洛伐克
        • 205.342.42106 Boehringer Ingelheim Investigational Site
      • Zilina、斯洛伐克
        • 205.342.42108 Boehringer Ingelheim Investigational Site
  • 比利时
      • Anderlecht、比利时
        • 205.342.32010 Boehringer Ingelheim Investigational Site
      • Angleur、比利时
        • 205.342.32005 Boehringer Ingelheim Investigational Site
      • Brussel、比利时
        • 205.342.32002 Boehringer Ingelheim Investigational Site
      • Bruxelles、比利时
        • 205.342.32007 Boehringer Ingelheim Investigational Site
      • Bruxelles、比利时
        • 205.342.32014 Boehringer Ingelheim Investigational Site
      • Gent、比利时
        • 205.342.32001 Boehringer Ingelheim Investigational Site
      • Herentals、比利时
        • 205.342.32003 Boehringer Ingelheim Investigational Site
      • Malmédy、比利时
        • 205.342.32004 Boehringer Ingelheim Investigational Site
      • Menen、比利时
        • 205.342.32012 Boehringer Ingelheim Investigational Site
      • Montigny-le-Tilleul、比利时
        • 205.342.32006 Boehringer Ingelheim Investigational Site
      • Namur、比利时
        • 205.342.32009 Boehringer Ingelheim Investigational Site
      • Turnhout、比利时
        • 205.342.32011 Boehringer Ingelheim Investigational Site
      • Yvoir、比利时
        • 205.342.32013 Boehringer Ingelheim Investigational Site
  • 法国
      • Brest、法国
        • 205.342.3305A Centre Hosp de la Cavale Blanche
      • Chamalières、法国
        • 205.342.3304A Cabinet Médical
      • Chauny、法国
        • 205.342.3307A Boehringer Ingelheim Investigational Site
      • Grenoble、法国
        • 205.342.3301A UCP-X - Clinique Médicale
      • Montpellier、法国
        • 205.342.3302A Hôpital Arnaud de Villeneuve
      • Poitiers、法国
        • 205.342.3306A Mediscis
      • Saint Pierre la Réunion、法国
        • 205.342.3308A Boehringer Ingelheim Investigational Site
      • Saint Pierre la Réunion、法国
        • 205.342.3308B Boehringer Ingelheim Investigational Site
  • 火鸡
      • Ankara、火鸡
        • 205.342.90001 Boehringer Ingelheim Investigational Site
      • Ankara、火鸡
        • 205.342.90006 Boehringer Ingelheim Investigational Site
      • Bursa、火鸡
        • 205.342.90003 Boehringer Ingelheim Investigational Site
      • Istanbul、火鸡
        • 205.342.90007 Istanbul Universitesi Cerrahpasa Tip Fakultesi
      • Izmit、火鸡
        • 205.342.90005 Kocaeli Universitesi Tip Fakultesi
      • Manisa、火鸡
        • 205.342.90004 Celal Bayar Universitesi Tip Fakultesi
  • 芬兰
      • Helsinki、芬兰
        • 205.342.35803 Boehringer Ingelheim Investigational Site
      • Jyväskylä、芬兰
        • 205.342.35801 Boehringer Ingelheim Investigational Site
      • Lahti、芬兰
        • 205.342.35802 Boehringer Ingelheim Investigational Site
      • Tampere、芬兰
        • 205.342.35804 Boehringer Ingelheim Investigational Site
  • 英国
      • Aylesbury、英国
        • 205.342.44002 Boehringer Ingelheim Investigational Site
      • Chertsey、英国
        • 205.342.44001 Boehringer Ingelheim Investigational Site
      • Greenisland、英国
        • 205.342.44003 Boehringer Ingelheim Investigational Site
      • Leicester、英国
        • 205.342.44006 Boehringer Ingelheim Investigational Site
      • Nottingham、英国
        • 205.342.44005 Boehringer Ingelheim Investigational Site
  • 西班牙
      • Barcelona、西班牙
        • 205.342.34006 Hospital Clinic i Provincial de Barcelona
      • Centelles、西班牙
        • 205.342.34011 Boehringer Ingelheim Investigational Site
      • Guadalajara、西班牙
        • 205.342.34004 Hospital General Universitario de Guadalajara
      • Las Palmas de Gran Canaria、西班牙
        • 205.342.34002 Hospital de Gran Canaria Dr. Negrín
      • Lleida、西班牙
        • 205.342.34007 Hospital Universitari Arnau de Vilanova
      • Madrid、西班牙
        • 205.342.34003 Hospital Universitario La Paz
      • Madrid、西班牙
        • 205.342.34009 Hospital Universio Puerta del Hierro
      • Santander、西班牙
        • 205.342.34008 Hospital Universitario Marqués de Valdecilla
      • Sevilla、西班牙
        • 205.342.34005 Hospital Vírgen de la Macarena
      • Valencia、西班牙
        • 205.342.34010 Hospital General Universitario de Valencia

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 65年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion_Criteria:

  1. Patients homozygous for arginine at the 16th amino acid position of the beta2 adrenergic receptor (B16 Arg/Arg)
  2. All patients must sign and date an Informed Consent Form for the study prior to participation in the trial
  3. Male or female outpatients with at least 18 years of age, but not older than 65 years
  4. Patients must have a documented history of asthma
  5. Patients must be current non-smokers or ex-smokers with a cigarette smoking history of <10 pack-years
  6. Patients must be on a maintenance treatment with inhaled corticosteroids with a total daily dose of 400 - 1000 mcg budesonide or equivalent

Exclusion_Criteria:

  1. Patients with a significant disease other than asthma
  2. Patients with a recent history (i.e., six months or less) of myocardial infarction
  3. Patients who have been hospitalized for heart failure (New York Heart Association class III or IV) within the past year
  4. Patients with any unstable or life threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year
  5. Patients with malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years. Patients with treated basal cell carcinoma are allowed.
  6. Patients with a diagnosis of chronic obstructive pulmonary disease (COPD)
  7. Patients with a history of life threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis
  8. Patients with known active tuberculosis
  9. Patients who have undergone thoracotomy with pulmonary resection.
  10. Patients who have completed a pulmonary rehabilitation program in the six weeks prior to visit 1 or patients who are currently in a pulmonary rehabilitation program that will not be maintained throughout the duration of the study.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 介入模型：并行分配

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in Mean Weekly Morning Peak Expiratory Flow From Baseline to the End of the Trial
大体时间：baseline and after 16 weeks of treatment
Change from baseline in mean weekly morning peak expiratory flow at 16 weeks. Baseline is defined as the last week prior to the randomisation visit
baseline and after 16 weeks of treatment

次要结果测量

结果测量
措施说明
大体时间
Mean Weekly Morning Peak Expiratory Flow at Week 4
大体时间：After 4 weeks of treatment
Mean weekly morning peak expiratory flow at week 4, pre-dose
After 4 weeks of treatment
Mean Weekly Morning Peak Expiratory Flow at Week 8
大体时间：After 8 weeks of treatment
Mean weekly morning peak expiratory flow at week 8, pre-dose
After 8 weeks of treatment
Mean Weekly Morning Peak Expiratory Flow at Week 12
大体时间：After 12 weeks of treatment
Mean weekly morning peak expiratory flow at week 12, pre-dose
After 12 weeks of treatment
Mean Weekly Morning Peak Expiratory Flow at Week 16
大体时间：After 16 weeks of treatment
Mean weekly morning peak expiratory flow at week 16, pre-dose
After 16 weeks of treatment
Mean Weekly Evening Peak Expiratory Flow at Week 4
大体时间：After 4 weeks of treatment
Mean weekly evening peak expiratory flow at week 4, pre-dose
After 4 weeks of treatment
Mean Weekly Evening Peak Expiratory Flow at Week 8
大体时间：After 8 weeks of treatment
Mean weekly evening peak expiratory flow at week 8, pre-dose
After 8 weeks of treatment
Mean Weekly Evening Peak Expiratory Flow at Week 12
大体时间：After 12 weeks of treatment
Mean weekly evening peak expiratory flow at week 12, pre-dose
After 12 weeks of treatment
Mean Weekly Evening Peak Expiratory Flow at Week 16
大体时间：After 16 weeks of treatment
Mean weekly evening peak expiratory flow at week 16, pre-dose
After 16 weeks of treatment
Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 4
大体时间：After 4 weeks of treatment
Mean weekly morning forced expiratory volume in 1 second at week 4, pre-dose
After 4 weeks of treatment
Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 8
大体时间：After 8 weeks of treatment
Mean weekly morning forced expiratory volume in 1 second at week 8, pre-dose
After 8 weeks of treatment
Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 12
大体时间：After 12 weeks of treatment
Mean weekly morning forced expiratory volume in 1 second at week 12, pre-dose
After 12 weeks of treatment
Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 16
大体时间：After 16 weeks of treatment
Mean weekly morning forced expiratory volume in 1 second at week 16, pre-dose
After 16 weeks of treatment
Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 4
大体时间：After 4 weeks of treatment
Mean weekly evening forced expiratory volume in 1 second at week 4, pre-dose
After 4 weeks of treatment
Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 8
大体时间：After 8 weeks of treatment
Mean weekly evening forced expiratory volume in 1 second at week 8, pre-dose
After 8 weeks of treatment
Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 12
大体时间：After 12 weeks of treatment
Mean weekly evening forced expiratory volume in 1 second at week 12, pre-dose
After 12 weeks of treatment
Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 16
大体时间：After 16 weeks of treatment
Mean weekly evening forced expiratory volume in 1 second at week 16, pre-dose
After 16 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "Did You Wake up During the Night Due to Asthma" at Week 4
大体时间：After 4 weeks of treatment
Unit on a scale 1-5. 1: Did not wake up, 2: Woke up once, 3: Woke up 2-5 times, 4: Woke up more than 5 times, 5: Was awake all night. 1 is the best value
After 4 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "Did You Wake up During the Night Due to Asthma" at Week 8
大体时间：After 8 weeks of treatment
Unit on a scale 1-5. 1: Did not wake up, 2: Woke up once, 3: Woke up 2-5 times, 4: Woke up more than 5 times, 5: Was awake all night. 1 is the best value
After 8 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "Did You Wake up During the Night Due to Asthma" at Week 12
大体时间：After 12 weeks of treatment
Unit on a scale 1-5. 1: Did not wake up, 2: Woke up once, 3: Woke up 2-5 times, 4: Woke up more than 5 times, 5: Was awake all night. 1 is the best value
After 12 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "Did You Wake up During the Night Due to Asthma" at Week 16
大体时间：After 16 weeks of treatment
Unit on a scale 1-5. 1: Did not wake up, 2: Woke up once, 3: Woke up 2-5 times, 4: Woke up more than 5 times, 5: Was awake all night. 1 is the best value
After 16 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms in the Morning" at Week 4
大体时间：After 4 weeks of treatment
Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value
After 4 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms This Morning" at Week 8
大体时间：After 8 weeks of treatment
Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value
After 8 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms This Morning" at Week 12
大体时间：After 12 weeks of treatment
Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value
After 12 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms This Morning" at Week 16
大体时间：After 16 weeks of treatment
Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value
After 16 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms During the Day" at Week 4
大体时间：After 4 weeks of treatment
Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value
After 4 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms During the Day" at Week 8
大体时间：After 8 weeks of treatment
Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value
After 8 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms During the Day" at Week 12
大体时间：After 12 weeks of treatment
Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value
After 12 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms During the Day" at Week 16
大体时间：After 16 weeks of treatment
Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value
After 16 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "How Limited Were You in Your Activities Today Because of Your Asthma" at Week 4
大体时间：After 4 weeks of treatment
Unit on a scale 1-5. 1: Not limited at all, 2: A little limited, 3: Moderately limited, 4: Severely limited, 5: Totally limited. 1 is the best value
After 4 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "How Limited Were You in Your Activities Today Because of Your Asthma" at Week 8
大体时间：After 8 weeks of treatment
Unit on a scale 1-5. 1: Not limited at all, 2: A little limited, 3: Moderately limited, 4: Severely limited, 5: Totally limited. 1 is the best value
After 8 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "How Limited Were You in Your Activities Today Because of Your Asthma" at Week 12
大体时间：After 12 weeks of treatment
Unit on a scale 1-5. 1: Not limited at all, 2: A little limited, 3: Moderately limited, 4: Severely limited, 5: Totally limited. 1 is the best value
After 12 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "How Limited Were You in Your Activities Today Because of Your Asthma" at Week 16
大体时间：After 16 weeks of treatment
Unit on a scale 1-5. 1: Not limited at all, 2: A little limited, 3: Moderately limited, 4: Severely limited, 5: Totally limited. 1 is the best value
After 16 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "How Much Shortness of Breath Did You Experience During the Day" at Week 4
大体时间：After 4 weeks of treatment
Unit on a scale 1-5. 1: None, 2: A very little, 3: A moderate amount, 4: Quite a lot, 5: A very great deal. 1 is the best value
After 4 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "How Much Shortness of Breath Did You Experience During the Day" at Week 8
大体时间：After 8 weeks of treatment
Unit on a scale 1-5. 1: None, 2: A very little, 3: A moderate amount, 4: Quite a lot, 5: A very great deal. 1 is the best value
After 8 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "How Much Shortness of Breath Did You Experience During the Day" at Week 12
大体时间：After 12 weeks of treatment
Unit on a scale 1-5. 1: None, 2: A very little, 3: A moderate amount, 4: Quite a lot, 5: A very great deal. 1 is the best value
After 12 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "How Much Shortness of Breath Did You Experience During the Day" at Week 16
大体时间：After 16 weeks of treatment
Unit on a scale 1-5. 1: None, 2: A very little, 3: A moderate amount, 4: Quite a lot, 5: A very great deal. 1 is the best value
After 16 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "Did You Experience Wheeze or Cough During the Day" at Week 4
大体时间：After 4 weeks of treatment
Unit on a scale 1-5. 1: Not at all, 2: A little of the time, 3: A moderate amount of the time, 4: Most of the time, 5: All the time. 1 is the best value
After 4 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "Did You Experience Wheeze or Cough During the Day" at Week 8
大体时间：After 8 weeks of treatment
Unit on a scale 1-5. 1: Not at all, 2: A little of the time, 3: A moderate amount of the time, 4: Most of the time, 5: All the time. 1 is the best value
After 8 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "Did You Experience Wheeze or Cough During the Day" at Week 12
大体时间：After 12 weeks of treatment
Unit on a scale 1-5. 1: Not at all, 2: A little of the time, 3: A moderate amount of the time, 4: Most of the time, 5: All the time. 1 is the best value
After 12 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "Did You Experience Wheeze or Cough During the Day" at Week 16
大体时间：After 16 weeks of treatment
Unit on a scale 1-5. 1: Not at all, 2: A little of the time, 3: A moderate amount of the time, 4: Most of the time, 5: All the time. 1 is the best value
After 16 weeks of treatment
Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 3
大体时间：After 6 weeks of treatment
Morning pre-dose forced expiratory volume in 1 second as measured by spirometry after 6 weeks of treatment
After 6 weeks of treatment
Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 4
大体时间：After 12 weeks of treatment
Morning pre-dose forced expiratory volume in 1 second as measured by spirometry after 12 weeks of treatment
After 12 weeks of treatment
Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 5
大体时间：After 16 weeks of treatment
Morning pre-dose forced expiratory volume in 1 second as measured by spirometry after 16 weeks od treatment
After 16 weeks of treatment
Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 3
大体时间：After 6 weeks of treatment
Morning pre-dose forced vital capacity as measured by spirometry after 6 weeks of treatment
After 6 weeks of treatment
Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 4
大体时间：After 12 weeks of treatment
Morning pre-dose forced vital capacity as measured by spirometry after 12 weeks of treatment
After 12 weeks of treatment
Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 5
大体时间：After 16 weeks of treatment
Morning pre-dose forced vital capacity as measured by spirometry after 16 weeks of treatment
After 16 weeks of treatment
Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ) Overall Score at Visit 3
大体时间：After 6 weeks of treatment
Mean of the responses to 15 questions from 4 domains: Symptoms (1), Activity Limitations (2), Emotional Function (3), Environmental Stimuli (4). Unit on a scale 1-7. For domain (2): 1: totally limited, 2: extremely limited, 3: very limited, 4: moderate limitation, 5: some limitation, 6: a little limitation, 7: not at all limited. For other domains: 1: all of the time, 2: most of the time, 3: a good bit of the time, 4: some of the time, 5: a little of the time, 6: hardly any of the time, 7: none of the time. 7 is the best value
After 6 weeks of treatment
Mini-AQLQ Overall Score at Visit 4
大体时间：After 12 weeks of treatment
Mean of the responses to 15 questions from 4 domains: Symptoms (1), Activity Limitations (2), Emotional Function (3), Environmental Stimuli (4). Unit on a scale 1-7. For domain (2): 1: totally limited, 2: extremely limited, 3: very limited, 4: moderate limitation, 5: some limitation, 6: a little limitation, 7: not at all limited. For other domains: 1: all of the time, 2: most of the time, 3: a good bit of the time, 4: some of the time, 5: a little of the time, 6: hardly any of the time, 7: none of the time. 7 is the best value
After 12 weeks of treatment
Mini-AQLQ Overall Score at Visit 5
大体时间：After 16 weeks of treatment
Mean of the responses to 15 questions from 4 domains: Symptoms (1), Activity Limitations (2), Emotional Function (3), Environmental Stimuli (4). Unit on a scale 1-7. For domain (2): 1: totally limited, 2: extremely limited, 3: very limited, 4: moderate limitation, 5: some limitation, 6: a little limitation, 7: not at all limited. For other domains: 1: all of the time, 2: most of the time, 3: a good bit of the time, 4: some of the time, 5: a little of the time, 6: hardly any of the time, 7: none of the time. 7 is the best value
After 16 weeks of treatment
Systolic Blood Pressure in Conjunction With Spirometry at Visit 3
大体时间：After 6 weeks of treatment
Systolic blood pressure collected in conjunction with spirometry at 6 weeks
After 6 weeks of treatment
Systolic Blood Pressure in Conjunction With Spirometry at Visit 4
大体时间：After 12 weeks of treatment
Systolic blood pressure collected in conjunction with spirometry at 12 weeks
After 12 weeks of treatment
Systolic Blood Pressure in Conjunction With Spirometry at Visit 5
大体时间：After 16 weeks of treatment
Systolic blood pressure collected in conjunction with spirometry at 16 weeks
After 16 weeks of treatment
Diastolic Blood Pressure in Conjunction With Spirometry at Visit 3
大体时间：After 6 weeks of treatment
Diastolic blood pressure collected in conjunction with spirometry at 6 weeks
After 6 weeks of treatment
Diastolic Blood Pressure in Conjunction With Spirometry at Visit 4
大体时间：After 12 weeks of treatment
Diastolic blood pressure collected in conjunction with spirometry at 12 weeks
After 12 weeks of treatment
Diastolic Blood Pressure in Conjunction With Spirometry at Visit 5
大体时间：After 16 weeks of treatment
Diastolic blood pressure collected in conjunction with spirometry at 16 weeks
After 16 weeks of treatment
Pulse Rate in Conjunction With Spirometry at Visit 3
大体时间：After 6 weeks of treatment
Pulse rate collected in conjunction with spirometry at 6 weeks
After 6 weeks of treatment
Pulse Rate in Conjunction With Spirometry at Visit 4
大体时间：After 12 weeks of treatment
Pulse rate collected in conjunction with spirometry at 12 weeks
After 12 weeks of treatment
Pulse Rate in Conjunction With Spirometry at Visit 5
大体时间：After 16 weeks of treatment
Pulse rate collected in conjunction with spirometry at 16 weeks
After 16 weeks of treatment
Mean PEF Variability at Week 4
大体时间：After 4 weeks of treatment
PEF (Peak expiratory flow) variability is defined as the difference between the highest morning PEF value and the highest evening PEF value of one day divided by the arithmetic mean of these two PEF values and multiplied by 100%
After 4 weeks of treatment
Mean PEF Variability at Week 8
大体时间：After 8 weeks of treatment
PEF (Peak expiratory flow) variability is defined as the difference between the highest morning PEF value and the highest evening PEF value of one day divided by the arithmetic mean of these two PEF values and multiplied by 100%
After 8 weeks of treatment
Mean PEF Variability at Week 12
大体时间：After 12 weeks of treatment
PEF (Peak expiratory flow) variability is defined as the difference between the highest morning PEF value and the highest evening PEF value of one day divided by the arithmetic mean of these two PEF values and multiplied by 100%
After 12 weeks of treatment
Mean PEF Variability at Week 16
大体时间：After 16 weeks of treatment
PEF (Peak expiratory flow) variability is defined as the difference between the highest morning PEF value and the highest evening PEF value of one day divided by the arithmetic mean of these two PEF values and multiplied by 100%
After 16 weeks of treatment

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Boehringer Ingelheim

出版物和有用的链接

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一般刊物

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2006年7月1日

初级完成 (实际的)

2008年9月1日

研究注册日期

首次提交

2006年7月7日

首先提交符合 QC 标准的

2006年7月7日

首次发布 (估计)

2006年7月10日

研究记录更新

最后更新发布 (估计)

2013年12月24日

上次提交的符合 QC 标准的更新

2013年11月27日

最后验证

2013年9月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 205.342

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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