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

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Placebo; Drug: Salmeterol xinafoate; Drug: Tiotropium bromide

• Study Type: Interventional
• Enrollment (Actual): 388
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Interventional Model: Parallel Assignment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Mean Weekly Morning Peak Expiratory Flow From Baseline to the End of the Trial	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Weekly Morning Peak Expiratory Flow at Week 4	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	Pulse rate collected in conjunction with spirometry at 6 weeks	After 6 weeks of treatment
Pulse Rate in Conjunction With Spirometry at Visit 4	Pulse rate collected in conjunction with spirometry at 12 weeks	After 12 weeks of treatment
Pulse Rate in Conjunction With Spirometry at Visit 5	Pulse rate collected in conjunction with spirometry at 16 weeks	After 16 weeks of treatment
Mean PEF Variability at Week 4	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	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	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	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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

General Publications

• Bateman ED, Kornmann O, Schmidt P, Pivovarova A, Engel M, Fabbri LM. Tiotropium is noninferior to salmeterol in maintaining improved lung function in B16-Arg/Arg patients with asthma. J Allergy Clin Immunol. 2011 Aug;128(2):315-22. doi: 10.1016/j.jaci.2011.06.004.

Helpful Links

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Study record dates

Study Major Dates

• Study Start: July 1, 2006
• Primary Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: July 7, 2006
• First Submitted That Met QC Criteria: July 7, 2006
• First Posted (Estimate): July 10, 2006

Study Record Updates

• Last Update Posted (Estimate): December 24, 2013
• Last Update Submitted That Met QC Criteria: November 27, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Antagonists; Cholinergic Agents; Adrenergic Agonists; Anticonvulsants; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Salmeterol Xinafoate; Tiotropium Bromide; Bromides
• Other Study ID Numbers: 205.342