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

27 ноября 2013 г. обновлено: 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.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Действительный)

388

Фаза

  • Фаза 2

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

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

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

От 18 лет до 65 лет (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

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.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Интервенционная модель: Параллельное назначение

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Change in Mean Weekly Morning Peak Expiratory Flow From Baseline to the End of the Trial
Временное ограничение: 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

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Mean Weekly Morning Peak Expiratory Flow at Week 4
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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

Соавторы и исследователи

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Спонсор

Boehringer Ingelheim

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Полезные ссылки

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования

1 июля 2006 г.

Первичное завершение (Действительный)

1 сентября 2008 г.

Даты регистрации исследования

Первый отправленный

7 июля 2006 г.

Впервые представлено, что соответствует критериям контроля качества

7 июля 2006 г.

Первый опубликованный (Оценивать)

10 июля 2006 г.

Обновления учебных записей

Последнее опубликованное обновление (Оценивать)

24 декабря 2013 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

27 ноября 2013 г.

Последняя проверка

1 сентября 2013 г.

Дополнительная информация

Термины, связанные с этим исследованием

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • 205.342

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