Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

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

27. November 2013 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

388

Phase

  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 65 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Interventionsmodell: Parallele Zuordnung

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Mean Weekly Morning Peak Expiratory Flow From Baseline to the End of the Trial
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Mean Weekly Morning Peak Expiratory Flow at Week 4
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Boehringer Ingelheim

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Juli 2006

Primärer Abschluss (Tatsächlich)

1. September 2008

Studienanmeldedaten

Zuerst eingereicht

7. Juli 2006

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

7. Juli 2006

Zuerst gepostet (Schätzen)

10. Juli 2006

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

24. Dezember 2013

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

27. November 2013

Zuletzt verifiziert

1. September 2013

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 205.342

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Klinische Studien zur Asthma

Klinische Studien zur Placebo

Suchen Sie nach ähnlichen Studien

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

CROs by country

CROs in Suriname

Bedingungen

Seltene Krankheiten

Drogeninterventionen

Nahrungsergänzungsmittel

Sponsor / Mitarbeiter

Standorte

Abonnieren