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

  Show 109 Study Locations
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
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Bromides
Salmeterol
Albuterol
Tiotropium
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents

ClinicalTrials.gov processed this record on July 29, 2014