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

27 de noviembre de 2013 actualizado por: 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

388

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 65 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Modelo Intervencionista: Asignación paralela

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Mean Weekly Morning Peak Expiratory Flow From Baseline to the End of the Trial
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Mean Weekly Morning Peak Expiratory Flow at Week 4
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Boehringer Ingelheim

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de julio de 2006

Finalización primaria (Actual)

1 de septiembre de 2008

Fechas de registro del estudio

Enviado por primera vez

7 de julio de 2006

Primero enviado que cumplió con los criterios de control de calidad

7 de julio de 2006

Publicado por primera vez (Estimar)

10 de julio de 2006

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

24 de diciembre de 2013

Última actualización enviada que cumplió con los criterios de control de calidad

27 de noviembre de 2013

Última verificación

1 de septiembre de 2013

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 205.342

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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