Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00350207
First received: July 7, 2006
Last updated: November 27, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: Tiotropium bromide
Drug: Placebo
Drug: Salmeterol xinafoate
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Change in Mean Weekly Morning Peak Expiratory Flow From Baseline to the End of the Trial [ Time Frame: baseline and after 16 weeks of treatment ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Mean Weekly Morning Peak Expiratory Flow at Week 4 [ Time Frame: After 4 weeks of treatment ] [ Designated as safety issue: No ]
    Mean weekly morning peak expiratory flow at week 4, pre-dose

  • Mean Weekly Morning Peak Expiratory Flow at Week 8 [ Time Frame: After 8 weeks of treatment ] [ Designated as safety issue: No ]
    Mean weekly morning peak expiratory flow at week 8, pre-dose

  • Mean Weekly Morning Peak Expiratory Flow at Week 12 [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
    Mean weekly morning peak expiratory flow at week 12, pre-dose

  • Mean Weekly Morning Peak Expiratory Flow at Week 16 [ Time Frame: After 16 weeks of treatment ] [ Designated as safety issue: No ]
    Mean weekly morning peak expiratory flow at week 16, pre-dose

  • Mean Weekly Evening Peak Expiratory Flow at Week 4 [ Time Frame: After 4 weeks of treatment ] [ Designated as safety issue: No ]
    Mean weekly evening peak expiratory flow at week 4, pre-dose

  • Mean Weekly Evening Peak Expiratory Flow at Week 8 [ Time Frame: After 8 weeks of treatment ] [ Designated as safety issue: No ]
    Mean weekly evening peak expiratory flow at week 8, pre-dose

  • Mean Weekly Evening Peak Expiratory Flow at Week 12 [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
    Mean weekly evening peak expiratory flow at week 12, pre-dose

  • Mean Weekly Evening Peak Expiratory Flow at Week 16 [ Time Frame: After 16 weeks of treatment ] [ Designated as safety issue: No ]
    Mean weekly evening peak expiratory flow at week 16, pre-dose

  • Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 4 [ Time Frame: After 4 weeks of treatment ] [ Designated as safety issue: No ]
    Mean weekly morning forced expiratory volume in 1 second at week 4, pre-dose

  • Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 8 [ Time Frame: After 8 weeks of treatment ] [ Designated as safety issue: No ]
    Mean weekly morning forced expiratory volume in 1 second at week 8, pre-dose

  • Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 12 [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
    Mean weekly morning forced expiratory volume in 1 second at week 12, pre-dose

  • Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 16 [ Time Frame: After 16 weeks of treatment ] [ Designated as safety issue: No ]
    Mean weekly morning forced expiratory volume in 1 second at week 16, pre-dose

  • Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 4 [ Time Frame: After 4 weeks of treatment ] [ Designated as safety issue: No ]
    Mean weekly evening forced expiratory volume in 1 second at week 4, pre-dose

  • Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 8 [ Time Frame: After 8 weeks of treatment ] [ Designated as safety issue: No ]
    Mean weekly evening forced expiratory volume in 1 second at week 8, pre-dose

  • Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 12 [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
    Mean weekly evening forced expiratory volume in 1 second at week 12, pre-dose

  • Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 16 [ Time Frame: After 16 weeks of treatment ] [ Designated as safety issue: No ]
    Mean weekly evening forced expiratory volume in 1 second at week 16, pre-dose

  • Mean Weekly Score for Asthma Control Diary Question "Did You Wake up During the Night Due to Asthma" at Week 4 [ Time Frame: After 4 weeks of treatment ] [ Designated as safety issue: No ]
    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

  • Mean Weekly Score for Asthma Control Diary Question "Did You Wake up During the Night Due to Asthma" at Week 8 [ Time Frame: After 8 weeks of treatment ] [ Designated as safety issue: No ]
    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

  • Mean Weekly Score for Asthma Control Diary Question "Did You Wake up During the Night Due to Asthma" at Week 12 [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
    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

  • Mean Weekly Score for Asthma Control Diary Question "Did You Wake up During the Night Due to Asthma" at Week 16 [ Time Frame: After 16 weeks of treatment ] [ Designated as safety issue: No ]
    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

  • Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms in the Morning" at Week 4 [ Time Frame: After 4 weeks of treatment ] [ Designated as safety issue: No ]
    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

  • Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms This Morning" at Week 8 [ Time Frame: After 8 weeks of treatment ] [ Designated as safety issue: No ]
    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

  • Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms This Morning" at Week 12 [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
    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

  • Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms This Morning" at Week 16 [ Time Frame: After 16 weeks of treatment ] [ Designated as safety issue: No ]
    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

  • Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms During the Day" at Week 4 [ Time Frame: After 4 weeks of treatment ] [ Designated as safety issue: No ]
    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

  • Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms During the Day" at Week 8 [ Time Frame: After 8 weeks of treatment ] [ Designated as safety issue: No ]
    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

  • Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms During the Day" at Week 12 [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
    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

  • Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms During the Day" at Week 16 [ Time Frame: After 16 weeks of treatment ] [ Designated as safety issue: No ]
    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

  • Mean Weekly Score for Asthma Control Diary Question "How Limited Were You in Your Activities Today Because of Your Asthma" at Week 4 [ Time Frame: After 4 weeks of treatment ] [ Designated as safety issue: No ]
    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

  • Mean Weekly Score for Asthma Control Diary Question "How Limited Were You in Your Activities Today Because of Your Asthma" at Week 8 [ Time Frame: After 8 weeks of treatment ] [ Designated as safety issue: No ]
    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

  • Mean Weekly Score for Asthma Control Diary Question "How Limited Were You in Your Activities Today Because of Your Asthma" at Week 12 [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
    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

  • Mean Weekly Score for Asthma Control Diary Question "How Limited Were You in Your Activities Today Because of Your Asthma" at Week 16 [ Time Frame: After 16 weeks of treatment ] [ Designated as safety issue: No ]
    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

  • Mean Weekly Score for Asthma Control Diary Question "How Much Shortness of Breath Did You Experience During the Day" at Week 4 [ Time Frame: After 4 weeks of treatment ] [ Designated as safety issue: No ]
    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

  • Mean Weekly Score for Asthma Control Diary Question "How Much Shortness of Breath Did You Experience During the Day" at Week 8 [ Time Frame: After 8 weeks of treatment ] [ Designated as safety issue: No ]
    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

  • Mean Weekly Score for Asthma Control Diary Question "How Much Shortness of Breath Did You Experience During the Day" at Week 12 [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
    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

  • Mean Weekly Score for Asthma Control Diary Question "How Much Shortness of Breath Did You Experience During the Day" at Week 16 [ Time Frame: After 16 weeks of treatment ] [ Designated as safety issue: No ]
    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

  • Mean Weekly Score for Asthma Control Diary Question "Did You Experience Wheeze or Cough During the Day" at Week 4 [ Time Frame: After 4 weeks of treatment ] [ Designated as safety issue: No ]
    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

  • Mean Weekly Score for Asthma Control Diary Question "Did You Experience Wheeze or Cough During the Day" at Week 8 [ Time Frame: After 8 weeks of treatment ] [ Designated as safety issue: No ]
    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

  • Mean Weekly Score for Asthma Control Diary Question "Did You Experience Wheeze or Cough During the Day" at Week 12 [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
    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

  • Mean Weekly Score for Asthma Control Diary Question "Did You Experience Wheeze or Cough During the Day" at Week 16 [ Time Frame: After 16 weeks of treatment ] [ Designated as safety issue: No ]
    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

  • Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 3 [ Time Frame: After 6 weeks of treatment ] [ Designated as safety issue: No ]
    Morning pre-dose forced expiratory volume in 1 second as measured by spirometry after 6 weeks of treatment

  • Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 4 [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
    Morning pre-dose forced expiratory volume in 1 second as measured by spirometry after 12 weeks of treatment

  • Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 5 [ Time Frame: After 16 weeks of treatment ] [ Designated as safety issue: No ]
    Morning pre-dose forced expiratory volume in 1 second as measured by spirometry after 16 weeks od treatment

  • Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 3 [ Time Frame: After 6 weeks of treatment ] [ Designated as safety issue: No ]
    Morning pre-dose forced vital capacity as measured by spirometry after 6 weeks of treatment

  • Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 4 [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
    Morning pre-dose forced vital capacity as measured by spirometry after 12 weeks of treatment

  • Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 5 [ Time Frame: After 16 weeks of treatment ] [ Designated as safety issue: No ]
    Morning pre-dose forced vital capacity as measured by spirometry after 16 weeks of treatment

  • Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ) Overall Score at Visit 3 [ Time Frame: After 6 weeks of treatment ] [ Designated as safety issue: No ]
    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

  • Mini-AQLQ Overall Score at Visit 4 [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
    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

  • Mini-AQLQ Overall Score at Visit 5 [ Time Frame: After 16 weeks of treatment ] [ Designated as safety issue: No ]
    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

  • Systolic Blood Pressure in Conjunction With Spirometry at Visit 3 [ Time Frame: After 6 weeks of treatment ] [ Designated as safety issue: No ]
    Systolic blood pressure collected in conjunction with spirometry at 6 weeks

  • Systolic Blood Pressure in Conjunction With Spirometry at Visit 4 [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
    Systolic blood pressure collected in conjunction with spirometry at 12 weeks

  • Systolic Blood Pressure in Conjunction With Spirometry at Visit 5 [ Time Frame: After 16 weeks of treatment ] [ Designated as safety issue: No ]
    Systolic blood pressure collected in conjunction with spirometry at 16 weeks

  • Diastolic Blood Pressure in Conjunction With Spirometry at Visit 3 [ Time Frame: After 6 weeks of treatment ] [ Designated as safety issue: No ]
    Diastolic blood pressure collected in conjunction with spirometry at 6 weeks

  • Diastolic Blood Pressure in Conjunction With Spirometry at Visit 4 [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
    Diastolic blood pressure collected in conjunction with spirometry at 12 weeks

  • Diastolic Blood Pressure in Conjunction With Spirometry at Visit 5 [ Time Frame: After 16 weeks of treatment ] [ Designated as safety issue: No ]
    Diastolic blood pressure collected in conjunction with spirometry at 16 weeks

  • Pulse Rate in Conjunction With Spirometry at Visit 3 [ Time Frame: After 6 weeks of treatment ] [ Designated as safety issue: No ]
    Pulse rate collected in conjunction with spirometry at 6 weeks

  • Pulse Rate in Conjunction With Spirometry at Visit 4 [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
    Pulse rate collected in conjunction with spirometry at 12 weeks

  • Pulse Rate in Conjunction With Spirometry at Visit 5 [ Time Frame: After 16 weeks of treatment ] [ Designated as safety issue: No ]
    Pulse rate collected in conjunction with spirometry at 16 weeks

  • Mean PEF Variability at Week 4 [ Time Frame: After 4 weeks of treatment ] [ Designated as safety issue: No ]
    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%

  • Mean PEF Variability at Week 8 [ Time Frame: After 8 weeks of treatment ] [ Designated as safety issue: No ]
    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%

  • Mean PEF Variability at Week 12 [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
    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%

  • Mean PEF Variability at Week 16 [ Time Frame: After 16 weeks of treatment ] [ Designated as safety issue: No ]
    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%


Enrollment: 388
Study Start Date: July 2006
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00350207

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

Additional Information:
No publications provided by Boehringer Ingelheim

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00350207     History of Changes
Other Study ID Numbers: 205.342
Study First Received: July 7, 2006
Results First Received: August 24, 2009
Last Updated: November 27, 2013
Health Authority: Austria: Federal Office for Safety in Health Care
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
France: French Health Products Safety Agency (AFSSAPS)
Germany: Federal Institute for Drugs and Medical Devices
Great Britain: MHRA
Greece: EOF-National Organisation for Medicines
Italy: Committee for the clinical experimentation of drug - Company Hospital University Pisana
Russia: Ministry of Health of the Russian Federation
Slovakia: State Institute for Drug Control
South Africa: Medicines Control Council
Spain: Spanish Medicines and Healthcare Products Agency
Turkey: Ministry of Health Central Ethics Committee
United States: Food and Drug Administration

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Salmeterol
Tiotropium
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Parasympatholytics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014