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

2013년 11월 27일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

388

단계

  • 2 단계

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연구 장소

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

참여기준

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

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion_Criteria:

  1. 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.

공부 계획

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

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 중재 모델: 병렬 할당

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in Mean Weekly Morning Peak Expiratory Flow From Baseline to the End of the Trial
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Mean Weekly Morning Peak Expiratory Flow at Week 4
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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스폰서

Boehringer Ingelheim

간행물 및 유용한 링크

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

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연구 기록 날짜

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

연구 주요 날짜

연구 시작

2006년 7월 1일

기본 완료 (실제)

2008년 9월 1일

연구 등록 날짜

최초 제출

2006년 7월 7일

QC 기준을 충족하는 최초 제출

2006년 7월 7일

처음 게시됨 (추정)

2006년 7월 10일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2013년 12월 24일

QC 기준을 충족하는 마지막 업데이트 제출

2013년 11월 27일

마지막으로 확인됨

2013년 9월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 205.342

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