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

27. november 2013 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

388

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • 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
  • Danmark
      • Aalborg, Danmark
        • 205.342.45003 Boehringer Ingelheim Investigational Site
      • Hvidovre, Danmark
        • 205.342.45001 Boehringer Ingelheim Investigational Site
      • Kobenhavn NV, Danmark
        • 205.342.45002 Boehringer Ingelheim Investigational Site
      • Odense C, Danmark
        • 205.342.45004 Boehringer Ingelheim Investigational Site
  • Den Russiske Føderation
      • Moscow, Den Russiske Føderation
        • 205.342.07001 Boehringer Ingelheim Investigational Site
      • Moscow, Den Russiske Føderation
        • 205.342.07002 Boehringer Ingelheim Investigational Site
      • Moscow, Den Russiske Føderation
        • 205.342.07003 Boehringer Ingelheim Investigational Site
      • Moscow, Den Russiske Føderation
        • 205.342.07004 Boehringer Ingelheim Investigational Site
      • Moscow, Den Russiske Føderation
        • 205.342.07005 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Den Russiske Føderation
        • 205.342.07006 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Den Russiske Føderation
        • 205.342.07007 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Den Russiske Føderation
        • 205.342.07008 Boehringer Ingelheim Investigational Site
  • Det Forenede Kongerige
      • Aylesbury, Det Forenede Kongerige
        • 205.342.44002 Boehringer Ingelheim Investigational Site
      • Chertsey, Det Forenede Kongerige
        • 205.342.44001 Boehringer Ingelheim Investigational Site
      • Greenisland, Det Forenede Kongerige
        • 205.342.44003 Boehringer Ingelheim Investigational Site
      • Leicester, Det Forenede Kongerige
        • 205.342.44006 Boehringer Ingelheim Investigational Site
      • Nottingham, Det Forenede Kongerige
        • 205.342.44005 Boehringer Ingelheim Investigational Site
  • Finland
      • Helsinki, Finland
        • 205.342.35803 Boehringer Ingelheim Investigational Site
      • Jyväskylä, Finland
        • 205.342.35801 Boehringer Ingelheim Investigational Site
      • Lahti, Finland
        • 205.342.35802 Boehringer Ingelheim Investigational Site
      • Tampere, Finland
        • 205.342.35804 Boehringer Ingelheim Investigational Site
  • Frankrig
      • Brest, Frankrig
        • 205.342.3305A Centre Hosp de la Cavale Blanche
      • Chamalières, Frankrig
        • 205.342.3304A Cabinet Médical
      • Chauny, Frankrig
        • 205.342.3307A Boehringer Ingelheim Investigational Site
      • Grenoble, Frankrig
        • 205.342.3301A UCP-X - Clinique Médicale
      • Montpellier, Frankrig
        • 205.342.3302A Hôpital Arnaud de Villeneuve
      • Poitiers, Frankrig
        • 205.342.3306A Mediscis
      • Saint Pierre la Réunion, Frankrig
        • 205.342.3308A Boehringer Ingelheim Investigational Site
      • Saint Pierre la Réunion, Frankrig
        • 205.342.3308B Boehringer Ingelheim Investigational Site
  • Grækenland
      • Athens, Grækenland
        • 205.342.30001 Boehringer Ingelheim Investigational Site
      • Athens, Grækenland
        • 205.342.30002 Boehringer Ingelheim Investigational Site
      • Heraklion, Grækenland
        • 205.342.30005 Boehringer Ingelheim Investigational Site
      • Kavala, Grækenland
        • 205.342.30006 Boehringer Ingelheim Investigational Site
      • Larisa, Grækenland
        • 205.342.30004 Boehringer Ingelheim Investigational Site
      • Thessaloniki, Grækenland
        • 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
  • Kalkun
      • Ankara, Kalkun
        • 205.342.90001 Boehringer Ingelheim Investigational Site
      • Ankara, Kalkun
        • 205.342.90006 Boehringer Ingelheim Investigational Site
      • Bursa, Kalkun
        • 205.342.90003 Boehringer Ingelheim Investigational Site
      • Istanbul, Kalkun
        • 205.342.90007 Istanbul Universitesi Cerrahpasa Tip Fakultesi
      • Izmit, Kalkun
        • 205.342.90005 Kocaeli Universitesi Tip Fakultesi
      • Manisa, Kalkun
        • 205.342.90004 Celal Bayar Universitesi Tip Fakultesi
  • Slovakiet
      • Banska Bystrica, Slovakiet
        • 205.342.42101 Boehringer Ingelheim Investigational Site
      • Bratislava, Slovakiet
        • 205.342.42102 Boehringer Ingelheim Investigational Site
      • Bratislava, Slovakiet
        • 205.342.42104 Boehringer Ingelheim Investigational Site
      • Bratislava, Slovakiet
        • 205.342.42105 Boehringer Ingelheim Investigational Site
      • Bratislava, Slovakiet
        • 205.342.42107 Boehringer Ingelheim Investigational Site
      • Kosice, Slovakiet
        • 205.342.42103 Boehringer Ingelheim Investigational Site
      • Trencin, Slovakiet
        • 205.342.42106 Boehringer Ingelheim Investigational Site
      • Zilina, Slovakiet
        • 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
  • Sydafrika
      • Bellville, Sydafrika
        • 205.342.27002 Boehringer Ingelheim Investigational Site
      • Bloemfontein, Sydafrika
        • 205.342.27008 Boehringer Ingelheim Investigational Site
      • Cape Town, Sydafrika
        • 205.342.27001 Boehringer Ingelheim Investigational Site
      • Cape Town, Sydafrika
        • 205.342.27004 Boehringer Ingelheim Investigational Site
      • Centurion, Sydafrika
        • 205.342.27006 Boehringer Ingelheim Investigational Site
      • Durban, Sydafrika
        • 205.342.27003 Boehringer Ingelheim Investigational Site
      • George, Sydafrika
        • 205.342.27007 Boehringer Ingelheim Investigational Site
      • Pretoria, Sydafrika
        • 205.342.27005 Boehringer Ingelheim Investigational Site
  • Tyskland
      • Beelitz-Heilstätten, Tyskland
        • 205.342.49016 Boehringer Ingelheim Investigational Site
      • Berlin, Tyskland
        • 205.342.49004 Boehringer Ingelheim Investigational Site
      • Berlin, Tyskland
        • 205.342.49006 Boehringer Ingelheim Investigational Site
      • Berlin, Tyskland
        • 205.342.49013 Boehringer Ingelheim Investigational Site
      • Bruchsal, Tyskland
        • 205.342.49003 Boehringer Ingelheim Investigational Site
      • Frankfurt/Main, Tyskland
        • 205.342.49011 Boehringer Ingelheim Investigational Site
      • Kassel, Tyskland
        • 205.342.49007 Boehringer Ingelheim Investigational Site
      • Köln, Tyskland
        • 205.342.49009 Boehringer Ingelheim Investigational Site
      • Mainz, Tyskland
        • 205.342.49010 Boehringer Ingelheim Investigational Site
      • Minden, Tyskland
        • 205.342.49008 Boehringer Ingelheim Investigational Site
      • Neuruppin, Tyskland
        • 205.342.49015 Boehringer Ingelheim Investigational Site
      • Rathenow, Tyskland
        • 205.342.49012 Boehringer Ingelheim Investigational Site
      • Rüdersdorf, Tyskland
        • 205.342.49005 Boehringer Ingelheim Investigational Site
      • Weinheim, Tyskland
        • 205.342.49002 Boehringer Ingelheim Investigational Site
  • Østrig
      • Graz, Østrig
        • 205.342.43002 Boehringer Ingelheim Investigational Site
      • Trofaiach, Østrig
        • 205.342.43004 Boehringer Ingelheim Investigational Site
      • Wels, Østrig
        • 205.342.43003 Boehringer Ingelheim Investigational Site
      • Wien, Østrig
        • 205.342.43001 Boehringer Ingelheim Investigational Site
      • Wien, Østrig
        • 205.342.43005 Boehringer Ingelheim Investigational Site
      • Wien, Østrig
        • 205.342.43006 Boehringer Ingelheim Investigational Site
      • Wien, Østrig
        • 205.342.43007 Boehringer Ingelheim Investigational Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Interventionel model: Parallel tildeling

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Mean Weekly Morning Peak Expiratory Flow From Baseline to the End of the Trial
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean Weekly Morning Peak Expiratory Flow at Week 4
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Boehringer Ingelheim

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2006

Primær færdiggørelse (Faktiske)

1. september 2008

Datoer for studieregistrering

Først indsendt

7. juli 2006

Først indsendt, der opfyldte QC-kriterier

7. juli 2006

Først opslået (Skøn)

10. juli 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

24. december 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. november 2013

Sidst verificeret

1. september 2013

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 205.342

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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