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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.

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

388

段階

  • フェーズ2

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • イギリス
      • Aylesbury、イギリス
        • 205.342.44002 Boehringer Ingelheim Investigational Site
      • Chertsey、イギリス
        • 205.342.44001 Boehringer Ingelheim Investigational Site
      • Greenisland、イギリス
        • 205.342.44003 Boehringer Ingelheim Investigational Site
      • Leicester、イギリス
        • 205.342.44006 Boehringer Ingelheim Investigational Site
      • Nottingham、イギリス
        • 205.342.44005 Boehringer Ingelheim Investigational Site
  • イタリア
      • Ferrara、イタリア
        • 205.342.39003 Azienda Ospedaliera " S. Anna"
      • Firenze、イタリア
        • 205.342.39006 Azienda Ospedaliera Universitaria Careggi
      • Genova、イタリア
        • 205.342.39005 Ospedale San Martino
      • Modena、イタリア
        • 205.342.39002 Università di Modena e Reggio Emilia
      • Orbassano (to)、イタリア
        • 205.342.39010 Boehringer Ingelheim Investigational Site
      • Pavia、イタリア
        • 205.342.39007 Policlinico San Matteo
      • Pisa、イタリア
        • 205.342.39001 Ospedale di Cisanello
      • Sesto San Giovanni (mi)、イタリア
        • 205.342.39009 Boehringer Ingelheim Investigational Site
  • オーストリア
      • Graz、オーストリア
        • 205.342.43002 Boehringer Ingelheim Investigational Site
      • Trofaiach、オーストリア
        • 205.342.43004 Boehringer Ingelheim Investigational Site
      • Wels、オーストリア
        • 205.342.43003 Boehringer Ingelheim Investigational Site
      • Wien、オーストリア
        • 205.342.43001 Boehringer Ingelheim Investigational Site
      • Wien、オーストリア
        • 205.342.43005 Boehringer Ingelheim Investigational Site
      • Wien、オーストリア
        • 205.342.43006 Boehringer Ingelheim Investigational Site
      • Wien、オーストリア
        • 205.342.43007 Boehringer Ingelheim Investigational Site
  • ギリシャ
      • Athens、ギリシャ
        • 205.342.30001 Boehringer Ingelheim Investigational Site
      • Athens、ギリシャ
        • 205.342.30002 Boehringer Ingelheim Investigational Site
      • Heraklion、ギリシャ
        • 205.342.30005 Boehringer Ingelheim Investigational Site
      • Kavala、ギリシャ
        • 205.342.30006 Boehringer Ingelheim Investigational Site
      • Larisa、ギリシャ
        • 205.342.30004 Boehringer Ingelheim Investigational Site
      • Thessaloniki、ギリシャ
        • 205.342.30003 Boehringer Ingelheim Investigational Site
  • スペイン
      • Barcelona、スペイン
        • 205.342.34006 Hospital Clinic i Provincial de Barcelona
      • Centelles、スペイン
        • 205.342.34011 Boehringer Ingelheim Investigational Site
      • Guadalajara、スペイン
        • 205.342.34004 Hospital General Universitario de Guadalajara
      • Las Palmas de Gran Canaria、スペイン
        • 205.342.34002 Hospital de Gran Canaria Dr. Negrín
      • Lleida、スペイン
        • 205.342.34007 Hospital Universitari Arnau de Vilanova
      • Madrid、スペイン
        • 205.342.34003 Hospital Universitario La Paz
      • Madrid、スペイン
        • 205.342.34009 Hospital Universio Puerta del Hierro
      • Santander、スペイン
        • 205.342.34008 Hospital Universitario Marqués de Valdecilla
      • Sevilla、スペイン
        • 205.342.34005 Hospital Vírgen de la Macarena
      • Valencia、スペイン
        • 205.342.34010 Hospital General Universitario de Valencia
  • スロバキア
      • Banska Bystrica、スロバキア
        • 205.342.42101 Boehringer Ingelheim Investigational Site
      • Bratislava、スロバキア
        • 205.342.42102 Boehringer Ingelheim Investigational Site
      • Bratislava、スロバキア
        • 205.342.42104 Boehringer Ingelheim Investigational Site
      • Bratislava、スロバキア
        • 205.342.42105 Boehringer Ingelheim Investigational Site
      • Bratislava、スロバキア
        • 205.342.42107 Boehringer Ingelheim Investigational Site
      • Kosice、スロバキア
        • 205.342.42103 Boehringer Ingelheim Investigational Site
      • Trencin、スロバキア
        • 205.342.42106 Boehringer Ingelheim Investigational Site
      • Zilina、スロバキア
        • 205.342.42108 Boehringer Ingelheim Investigational Site
  • デンマーク
      • Aalborg、デンマーク
        • 205.342.45003 Boehringer Ingelheim Investigational Site
      • Hvidovre、デンマーク
        • 205.342.45001 Boehringer Ingelheim Investigational Site
      • Kobenhavn NV、デンマーク
        • 205.342.45002 Boehringer Ingelheim Investigational Site
      • Odense C、デンマーク
        • 205.342.45004 Boehringer Ingelheim Investigational Site
  • ドイツ
      • Beelitz-Heilstätten、ドイツ
        • 205.342.49016 Boehringer Ingelheim Investigational Site
      • Berlin、ドイツ
        • 205.342.49004 Boehringer Ingelheim Investigational Site
      • Berlin、ドイツ
        • 205.342.49006 Boehringer Ingelheim Investigational Site
      • Berlin、ドイツ
        • 205.342.49013 Boehringer Ingelheim Investigational Site
      • Bruchsal、ドイツ
        • 205.342.49003 Boehringer Ingelheim Investigational Site
      • Frankfurt/Main、ドイツ
        • 205.342.49011 Boehringer Ingelheim Investigational Site
      • Kassel、ドイツ
        • 205.342.49007 Boehringer Ingelheim Investigational Site
      • Köln、ドイツ
        • 205.342.49009 Boehringer Ingelheim Investigational Site
      • Mainz、ドイツ
        • 205.342.49010 Boehringer Ingelheim Investigational Site
      • Minden、ドイツ
        • 205.342.49008 Boehringer Ingelheim Investigational Site
      • Neuruppin、ドイツ
        • 205.342.49015 Boehringer Ingelheim Investigational Site
      • Rathenow、ドイツ
        • 205.342.49012 Boehringer Ingelheim Investigational Site
      • Rüdersdorf、ドイツ
        • 205.342.49005 Boehringer Ingelheim Investigational Site
      • Weinheim、ドイツ
        • 205.342.49002 Boehringer Ingelheim Investigational Site
  • フィンランド
      • Helsinki、フィンランド
        • 205.342.35803 Boehringer Ingelheim Investigational Site
      • Jyväskylä、フィンランド
        • 205.342.35801 Boehringer Ingelheim Investigational Site
      • Lahti、フィンランド
        • 205.342.35802 Boehringer Ingelheim Investigational Site
      • Tampere、フィンランド
        • 205.342.35804 Boehringer Ingelheim Investigational Site
  • フランス
      • Brest、フランス
        • 205.342.3305A Centre Hosp de la Cavale Blanche
      • Chamalières、フランス
        • 205.342.3304A Cabinet Médical
      • Chauny、フランス
        • 205.342.3307A Boehringer Ingelheim Investigational Site
      • Grenoble、フランス
        • 205.342.3301A UCP-X - Clinique Médicale
      • Montpellier、フランス
        • 205.342.3302A Hôpital Arnaud de Villeneuve
      • Poitiers、フランス
        • 205.342.3306A Mediscis
      • Saint Pierre la Réunion、フランス
        • 205.342.3308A Boehringer Ingelheim Investigational Site
      • Saint Pierre la Réunion、フランス
        • 205.342.3308B Boehringer Ingelheim Investigational Site
  • ベルギー
      • Anderlecht、ベルギー
        • 205.342.32010 Boehringer Ingelheim Investigational Site
      • Angleur、ベルギー
        • 205.342.32005 Boehringer Ingelheim Investigational Site
      • Brussel、ベルギー
        • 205.342.32002 Boehringer Ingelheim Investigational Site
      • Bruxelles、ベルギー
        • 205.342.32007 Boehringer Ingelheim Investigational Site
      • Bruxelles、ベルギー
        • 205.342.32014 Boehringer Ingelheim Investigational Site
      • Gent、ベルギー
        • 205.342.32001 Boehringer Ingelheim Investigational Site
      • Herentals、ベルギー
        • 205.342.32003 Boehringer Ingelheim Investigational Site
      • Malmédy、ベルギー
        • 205.342.32004 Boehringer Ingelheim Investigational Site
      • Menen、ベルギー
        • 205.342.32012 Boehringer Ingelheim Investigational Site
      • Montigny-le-Tilleul、ベルギー
        • 205.342.32006 Boehringer Ingelheim Investigational Site
      • Namur、ベルギー
        • 205.342.32009 Boehringer Ingelheim Investigational Site
      • Turnhout、ベルギー
        • 205.342.32011 Boehringer Ingelheim Investigational Site
      • Yvoir、ベルギー
        • 205.342.32013 Boehringer Ingelheim Investigational Site
  • ロシア連邦
      • Moscow、ロシア連邦
        • 205.342.07001 Boehringer Ingelheim Investigational Site
      • Moscow、ロシア連邦
        • 205.342.07002 Boehringer Ingelheim Investigational Site
      • Moscow、ロシア連邦
        • 205.342.07003 Boehringer Ingelheim Investigational Site
      • Moscow、ロシア連邦
        • 205.342.07004 Boehringer Ingelheim Investigational Site
      • Moscow、ロシア連邦
        • 205.342.07005 Boehringer Ingelheim Investigational Site
      • St. Petersburg、ロシア連邦
        • 205.342.07006 Boehringer Ingelheim Investigational Site
      • St. Petersburg、ロシア連邦
        • 205.342.07007 Boehringer Ingelheim Investigational Site
      • St. Petersburg、ロシア連邦
        • 205.342.07008 Boehringer Ingelheim Investigational Site
  • 七面鳥
      • Ankara、七面鳥
        • 205.342.90001 Boehringer Ingelheim Investigational Site
      • Ankara、七面鳥
        • 205.342.90006 Boehringer Ingelheim Investigational Site
      • Bursa、七面鳥
        • 205.342.90003 Boehringer Ingelheim Investigational Site
      • Istanbul、七面鳥
        • 205.342.90007 Istanbul Universitesi Cerrahpasa Tip Fakultesi
      • Izmit、七面鳥
        • 205.342.90005 Kocaeli Universitesi Tip Fakultesi
      • Manisa、七面鳥
        • 205.342.90004 Celal Bayar Universitesi Tip Fakultesi
  • 南アフリカ
      • Bellville、南アフリカ
        • 205.342.27002 Boehringer Ingelheim Investigational Site
      • Bloemfontein、南アフリカ
        • 205.342.27008 Boehringer Ingelheim Investigational Site
      • Cape Town、南アフリカ
        • 205.342.27001 Boehringer Ingelheim Investigational Site
      • Cape Town、南アフリカ
        • 205.342.27004 Boehringer Ingelheim Investigational Site
      • Centurion、南アフリカ
        • 205.342.27006 Boehringer Ingelheim Investigational Site
      • Durban、南アフリカ
        • 205.342.27003 Boehringer Ingelheim Investigational Site
      • George、南アフリカ
        • 205.342.27007 Boehringer Ingelheim Investigational Site
      • Pretoria、南アフリカ
        • 205.342.27005 Boehringer Ingelheim Investigational Site

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年～65年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 介入モデル：並列代入

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in Mean Weekly Morning Peak Expiratory Flow From Baseline to the End of the Trial
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Mean Weekly Morning Peak Expiratory Flow at Week 4
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Boehringer Ingelheim

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

便利なリンク

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2006年7月1日

一次修了 (実際)

2008年9月1日

試験登録日

最初に提出

2006年7月7日

QC基準を満たした最初の提出物

2006年7月7日

最初の投稿 (見積もり)

2006年7月10日

学習記録の更新

投稿された最後の更新 (見積もり)

2013年12月24日

QC基準を満たした最後の更新が送信されました

2013年11月27日

最終確認日

2013年9月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • 205.342

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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