Inhaled Corticosteroid Withdrawal in Patients With Chronic Obstructive Pulmonary Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00975195
First received: September 10, 2009
Last updated: February 9, 2015
Last verified: February 2015
  Purpose

This is a randomised study to be conducted in patients with severe to very severe Chronic Obstructive Pulmonary Disease (COPD) to establish whether there is a need for these patients to be continuously treated with an inhaled corticosteroid on top of two potent long-acting bronchodilators. The study also aims to identify the type of patients who are likely to benefit from inhaled corticosteroid maintenance therapy.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Drug: tiotropium inhalation
Drug: salmeterol xinafoate
Drug: fluticasone propionate
Drug: placebo matched for fluticasone propionate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Active-controlled Study to Evaluate the Impact of Stepwise Withdrawal of Inhaled Corticosteroid Treatment in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease (COPD) on Optimized Bronchodilator Therapy

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Time to First Moderate or Severe On-treatment COPD Exacerbation [ Time Frame: During randomised treatment, up to 488 days ] [ Designated as safety issue: No ]
    A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as an increase or new onset of ≥2 lower respiratory symptoms related to COPD, with ≥1 symptom lasting ≥3 days, requiring a change in treatment. Lower respiratory symptoms included shortness of breath, sputum production (volume), sputum purulence, cough, wheezing and chest tightness. A change in treatment included: hospitalisation/treatment in an urgent care unit, prescription of antibiotics and/or systemic steroids or a significant change of prescribed respiratory medication such as theophyllines, long-acting beta-agonists or inhaled corticosteroids. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for >6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital.The "measure type" displays the 25th percentile and its 95% confidence interval.


Secondary Outcome Measures:
  • Number of Moderate or Severe On-treatment COPD Exacerbations [ Time Frame: During randomised treatment, up to 488 days ] [ Designated as safety issue: No ]

    Number of moderate or severe on-treatment COPD exacerbations, based on a 7-day gap rule: exacerbations where the onset date of the second exacerbation event was ≤7 days after the end date of the first exacerbation event were combined and counted as moderate or severe if ≥1 of the contributing exacerbation events was moderate or severe. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for >6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital. Exacerbations were considered moderate if they required prescription of antibiotics and/or systemic steroids.

    Measured values show adjusted mean event rate.


  • Proportion of Patients With ≥1 Moderate or Severe On-treatment COPD Exacerbation [ Time Frame: During randomised treatment, up to 488 days ] [ Designated as safety issue: No ]
    Presence (yes vs no) of at least one moderate or severe on-treatment COPD exacerbation, displayed as a percentage. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for >6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital. Exacerbations were considered moderate if they required prescription of antibiotics and/or systemic steroids.

  • Time to First Severe On-treatment COPD Exacerbation [ Time Frame: During randomised treatment, up to 488 days ] [ Designated as safety issue: No ]

    Time to first severe on-treatment COPD exacerbation. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for >6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital.

    The "measure type" displays the 25th percentile and its 95% confidence interval.


  • Number of Severe On-treatment COPD Exacerbations [ Time Frame: During randomised treatment, up to 488 days ] [ Designated as safety issue: No ]

    Number of severe on-treatment COPD exacerbations based on a 7-day gap rule: exacerbations where the onset date of the second exacerbation event was ≤7 days after the end date of the first exacerbation event were combined and counted as severe if ≥1 of the contributing exacerbation events was severe. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for >6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital.

    Measured values show adjusted event rate.


  • Proportion of Patients With at Least One Severe On-treatment COPD Exacerbation. [ Time Frame: During randomised treatment, up to 488 days ] [ Designated as safety issue: No ]
    Presence (yes vs no) of at least one severe on-treatment COPD exacerbation, displayed as a percentage. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for >6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital.

  • Time to First On-treatment COPD Exacerbation [ Time Frame: During randomised treatment, up to 488 days ] [ Designated as safety issue: No ]
    Time to first on-treatment COPD exacerbation of any severity. The "measure type" displays the 25th percentile and its 95% confidence interval.

  • Number of On-treatment COPD Exacerbations [ Time Frame: During randomised treatment, up to 488 days ] [ Designated as safety issue: No ]

    Number of on-treatment COPD exacerbations of any severity, based on a 7-day gap rule: exacerbations where the onset date of the second exacerbation event was ≤7 days after the end date of the first exacerbation event were combined.

    Measured values show adjusted event rate.


  • Proportion of Patients With at Least One On-treatment COPD Exacerbation [ Time Frame: During randomised treatment, up to 488 days ] [ Designated as safety issue: No ]
    Presence (yes vs no) of at least one on-treatment COPD exacerbation of any severity, displayed as a percentage.

  • Severity of On-treatment COPD Exacerbations [ Time Frame: During randomised treatment, up to 488 days ] [ Designated as safety issue: No ]
    Severity of on-treatment COPD exacerbations: for each patient, the worst applicable category was taken (i.e. none, mild, moderate or severe)

  • Change in On-treatment Lung Function as Measured by Trough FEV1 [ Time Frame: Baseline and week 6, 12, 18 and 52 visits ] [ Designated as safety issue: No ]
    Change from baseline in on-treatment lung function as measured by trough forced expiratory volume in one second (FEV1); change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.

  • Changes in On-treatment Dyspnoea as Measured by the Modified Medical Research Council (MMRC) Dyspnoea Scale [ Time Frame: Baseline and week 18 and 52 visits ] [ Designated as safety issue: No ]

    Change from baseline in on-treatment dyspnoea as measured by the Modified Medical Research Council (MMRC) dyspnoea scale; change was calculated as week score minus baseline score. Negative changes from baseline indicate an improvement in health.

    Scale from 0 to 4:

    • 0 = not troubled by breathlessness, except during strenuous exercise
    • 1 = short of breath when hurrying or walking up a slight hill
    • 2 = walks slower than contemporaries on the same level because of breathlessness, or has to stop for breath when walking at own pace
    • 3 = stops for breath after approximately 100 yards, or after a few minutes on the level
    • 4 = too breathless to leave the house, or breathless when dressing or undressing

    "No breathlessness" was given a score of -1

    Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.


  • Change in On-treatment Physical Health Status as Determined by Body Mass Index (BMI) [ Time Frame: Baseline and week 18 and 52 visits ] [ Designated as safety issue: No ]
    Change from baseline in on-treatment physical health status as determined by body mass index (BMI); change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.

  • Change in On-treatment Exercise Capacity Measured by Six-minute Walk Test (6-MWT) [ Time Frame: Baseline and week 18 and 52 visits ] [ Designated as safety issue: No ]
    Change from baseline in on-treatment exercise capacity measured by six-minute walk test (6-MWT); change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.

  • Change in On-treatment BODE Index [ Time Frame: Baseline and week 18 and 52 visits ] [ Designated as safety issue: No ]
    Change from baseline in on-treatment BODE index (Body mass index, airflow Obstruction, Dyspnea and Exercise capacity index), a composite score ranging from 0 (best) to 10 (worst); change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.

  • Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Cough Impact Domain [ Time Frame: Baseline and week 12, 18 and 52 visits ] [ Designated as safety issue: No ]

    Change from baseline in on-treatment cough and expectoration as measured by the cough and sputum assessment questionnaire (CASA-Q) (selected sites only): Cough impact domain. Change was calculated as week score minus baseline score. Response options for the items in this domain range from "not at all/never" to "extremely/always" on a five-point scale. Domain items were reverse scored, summed and transformed to a domain score ranging from 0 to 100 where a higher score is associated with less impact due to cough.

    Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.


  • Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Cough Symptoms Domain [ Time Frame: Baseline and week 12, 18 and 52 visits ] [ Designated as safety issue: No ]

    Change from baseline in on-treatment cough and expectoration as measured by the cough and sputum assessment questionnaire (CASA-Q) (selected sites only): Cough symptoms domain. Change was calculated as week score minus baseline score. Response options for the items in this domain range from "not at all/never" to "a lot/always" on a five-point scale. Domain items were reverse scored, summed and transformed to a domain score ranging from 0 to 100 where a higher score is associated with less symptoms due to cough.

    Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.


  • Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Sputum Impact Domain [ Time Frame: Baseline and week 12, 18 and 52 visits ] [ Designated as safety issue: No ]

    Change from baseline in on-treatment cough and expectoration as measured by the cough and sputum assessment questionnaire (CASA-Q) (selected sites only): Sputum impact domain. Change was calculated as week score minus baseline score. Response options for the items in this domain range from "not at all/never" to "a lot/always" on a five-point scale. Domain items were reverse scored, summed and transformed to a domain score ranging from 0 to 100 where a higher score is associated with less impact due to sputum.

    Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.


  • Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Sputum Symptoms Domain [ Time Frame: Baseline and week 12, 18 and 52 visits ] [ Designated as safety issue: No ]

    Change from baseline in on-treatment cough and expectoration as measured by the cough and sputum assessment questionnaire (CASA-Q) (selected sites only): Sputum symptoms domain. Change was calculated as week score minus baseline score. Response options for the items in this domain range from "not at all/never" to "extremely/always" on a five-point scale. Domain items were reverse scored, summed and transformed to a domain score ranging from 0 to 100 where a higher score is associated with less symptoms due to sputum.

    Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.


  • Change in On-treatment FEV1 as Measured by Home Based Spirometry [ Time Frame: Baseline and week 6, 12, 18, 27, 36, 45 and 52 visits ] [ Designated as safety issue: No ]
    Change from baseline in on-treatment Forced Expiratory Volume in One Second (FEV1) as measured by home based spirometry. Change was calculated as week score minus baseline score. The weekly mean was defined as the mean of the measurements taken during the last 7 days prior to the visit date, and was calculated if ≥4 of the 7 days had non-missing measurements. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.

  • Change in On-treatment FVC as Measured by Home Based Spirometry [ Time Frame: Baseline and week 6, 12, 18, 27, 36, 45 and 52 visits ] [ Designated as safety issue: No ]
    Change from baseline in on-treatment forced vital capacity (FVC) as measured by home based spirometry. Change was calculated as week score minus baseline score. The weekly mean was defined as the mean of the measurements taken during the last 7 days prior to the visit date, and was calculated if ≥4 of the 7 days had non-missing measurements. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.

  • Change in On-treatment PEFR as Measured by Home Based Spirometry [ Time Frame: Baseline and week 6, 12, 18, 27, 36, 45 and 52 visits ] [ Designated as safety issue: No ]
    Change from baseline in on-treatment peak expiratory flow rate (PEFR) as measured by home based spirometry; change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.

  • Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Activity Domain [ Time Frame: Baseline and week 27 and 52 visits ] [ Designated as safety issue: No ]

    Change from baseline in on-treatment St Georges Respiratory Questionnaire (SGRQ) scores: Activity domain. Scores range from 0 to 100, with higher scores indicating more limitations. Change was calculated as week score minus baseline score.

    Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.


  • Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Impact Domain [ Time Frame: Baseline and week 27 and 52 visits ] [ Designated as safety issue: No ]

    Change from baseline in on-treatment St Georges Respiratory Questionnaire (SGRQ) scores: Impact Domain. Scores range from 0 to 100, with higher scores indicating more limitations. Change was calculated as week score minus baseline score.

    Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.


  • Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Symptoms Domain [ Time Frame: Baseline and week 27 and 52 visits ] [ Designated as safety issue: No ]

    Change from baseline in on-treatment St Georges Respiratory Questionnaire (SGRQ) scores: Symptoms domain. Scores range from 0 to 100, with higher scores indicating more limitations. Change was calculated as week score minus baseline score.

    Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.


  • Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Total Score [ Time Frame: Baseline and week 27 and 52 visits ] [ Designated as safety issue: No ]

    Change from baseline in on-treatment St Georges Respiratory Questionnaire (SGRQ) scores: Total score. Scores range from 0 to 100, with higher scores indicating more limitations. Change was calculated as week score minus baseline score.

    Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.


  • Change in On-treatment Physician Global Evaluation [ Time Frame: Baseline and week 27 and 52 visits ] [ Designated as safety issue: No ]

    Change from baseline in on-treatment physician global evaluation. The evaluation reflected the physician's opinion of the patient's overall condition and was based on the need for concomitant medication, the number and severity of exacerbations, the severity of cough, the ability to exercise, the amount of wheezing and any other relevant clinical observations. Patients were graded on a scale of 1 (poor) to 8 (excellent). Change was calculated as week score minus baseline score.

    Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.



Enrollment: 2488
Study Start Date: February 2009
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: fluticasone high dose
fluticasone priopionate high dose and tiotropium inhalation and salmeterol xinafoate
Drug: tiotropium inhalation Drug: salmeterol xinafoate Drug: fluticasone propionate
Experimental: fluticasone medium & low doses
fluticasone priopionate medium and high doses; and tiotropium inhalation; and salmeterol xinafoate; and placebo matched to fluticasone priopionate
Drug: tiotropium inhalation Drug: salmeterol xinafoate Drug: fluticasone propionate Drug: placebo matched for fluticasone propionate

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Male or female aged 40 years or more
  2. Severe to very severe chronic obstructive pulmonary disease (COPD)
  3. Current or ex-smoker with smoking history of at least 10 pack years
  4. At least one documented exacerbation of COPD in previous year

Exclusion criteria:

  1. Significant diseases other than COPD; significant alcohol or drug abuse
  2. Current clinical diagnosis of asthma requiring steroid treatment
  3. History of thoracotomy with pulmonary resection
  4. Regular use of daytime oxygen
  5. Recent history (within 3 months) of myocardial infarction
  6. Recent (within 6 weeks) respiratory infection or COPD exacerbation
  7. Recent (within 6 weeks) treatment with systemic corticosteroids at doses in excess of 5milligram / day
  8. Recent (within 3 months) unstable or life-threatening cardiac arrhythmia requiring intervention
  9. Recent (within 1 year) hospitalisation for cardiac failure
  10. Malignancy requiring chemotherapy or radiotherapy
  11. Clinical diagnosis of bronchiectasis
  12. Pregnant or nursing women
  13. Known hypersensitivity to study drugs
  14. Current or recent (within 30 days) participation in another clinical study
  15. Current participation in or recent completion (within 4 weeks) of a pulmonary rehabilitation program
  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: NCT00975195

  Hide Study Locations
Locations
Australia, New South Wales
352.2046.61006 Boehringer Ingelheim Investigational Site
Concord, New South Wales, Australia
352.2046.61001 Boehringer Ingelheim Investigational Site
Glebe, New South Wales, Australia
352.2046.61002 Boehringer Ingelheim Investigational Site
Westmead, New South Wales, Australia
Australia, South Australia
352.2046.61004 Boehringer Ingelheim Investigational Site
Daw Park, South Australia, Australia
352.2046.61003 Boehringer Ingelheim Investigational Site
Toorak Gardens, South Australia, Australia
352.2046.61005 Boehringer Ingelheim Investigational Site
Woodville, South Australia, Australia
Belgium
352.2046.32002 Boehringer Ingelheim Investigational Site
Bruxelles, Belgium
352.2046.32016 Boehringer Ingelheim Investigational Site
Bruxelles, Belgium
352.2046.32015 Boehringer Ingelheim Investigational Site
Eupen, Belgium
352.2046.32017 Boehringer Ingelheim Investigational Site
Gilly, Belgium
352.2046.32014 Boehringer Ingelheim Investigational Site
Herentals, Belgium
352.2046.32006 Boehringer Ingelheim Investigational Site
Jambes, Belgium
352.2046.32008 Boehringer Ingelheim Investigational Site
Lebbeke, Belgium
352.2046.32001 Boehringer Ingelheim Investigational Site
Leuven, Belgium
352.2046.32004 Boehringer Ingelheim Investigational Site
Middelheim, Belgium
352.2046.32010 Boehringer Ingelheim Investigational Site
Montigny-le-Tilleul, Belgium
352.2046.32013 Boehringer Ingelheim Investigational Site
Turnhout, Belgium
Brazil
352.2046.55005 Boehringer Ingelheim Investigational Site
Goiania, Brazil
352.2046.55002 Boehringer Ingelheim Investigational Site
Goiânia, Brazil
352.2046.55001 Boehringer Ingelheim Investigational Site
Porto Alegre, Brazil
352.2046.55006 Boehringer Ingelheim Investigational Site
Porto Alegre, Brazil
352.2046.55003 Boehringer Ingelheim Investigational Site
Sao Paulo, Brazil
Bulgaria
352.2046.35905 Boehringer Ingelheim Investigational Site
Bourgas, Bulgaria
352.2046.35902 Boehringer Ingelheim Investigational Site
Rousse, Bulgaria
352.2046.35907 Boehringer Ingelheim Investigational Site
Sofia, Bulgaria
352.2046.35906 Boehringer Ingelheim Investigational Site
Sofia, Bulgaria
352.2046.35908 Boehringer Ingelheim Investigational Site
Sofia, Bulgaria
352.2046.35904 Boehringer Ingelheim Investigational Site
Sofia, Bulgaria
352.2046.35903 Boehringer Ingelheim Investigational Site
Stara Zagora, Bulgaria
352.2046.35909 Boehringer Ingelheim Investigational Site
Veliko Tarnovo, Bulgaria
China
352.2046.86006 Boehringer Ingelheim Investigational Site
Beijing, China
352.2046.86002 Boehringer Ingelheim Investigational Site
Beijing, China
352.2046.86003 Boehringer Ingelheim Investigational Site
Beijing, China
352.2046.86008 Boehringer Ingelheim Investigational Site
Chongqing, China
352.2046.86001 Boehringer Ingelheim Investigational Site
Guangzhou, China
352.2046.86004 Boehringer Ingelheim Investigational Site
Shanghai, China
352.2046.86005 Boehringer Ingelheim Investigational Site
Shanghai, China
352.2046.86007 Boehringer Ingelheim Investigational Site
Wuhan, China
Denmark
352.2046.45001 Boehringer Ingelheim Investigational Site
Aarhus C, Denmark
352.2046.45003 Boehringer Ingelheim Investigational Site
København NV, Denmark
352.2046.45002 Boehringer Ingelheim Investigational Site
Odense C, Denmark
France
352.2046.3317A Boehringer Ingelheim Investigational Site
Brest, France
352.2046.3317B Boehringer Ingelheim Investigational Site
Brest, France
352.2046.3317C Boehringer Ingelheim Investigational Site
Brest, France
352.2046.3320A Boehringer Ingelheim Investigational Site
Castelnau le Lez, France
352.2046.3320B Boehringer Ingelheim Investigational Site
Castelnau le Lez, France
352.2046.3320C Boehringer Ingelheim Investigational Site
Castelnau le Lez, France
352.2046.3335A Boehringer Ingelheim Investigational Site
Clermont Ferrand cedex 1, France
352.2046.3314A Boehringer Ingelheim Investigational Site
Forbach, France
352.2046.3333A Boehringer Ingelheim Investigational Site
Marseille, France
352.2046.3301A Boehringer Ingelheim Investigational Site
Marseille cedex 20, France
352.2046.3326C Boehringer Ingelheim Investigational Site
Montpellier, France
352.2046.3326A Boehringer Ingelheim Investigational Site
Montpellier, France
352.2046.3334A Boehringer Ingelheim Investigational Site
Nantes, France
352.2046.3325A Boehringer Ingelheim Investigational Site
Nantes Cedex 1, France
352.2046.3325C Boehringer Ingelheim Investigational Site
Nantes Cedex 1, France
352.2046.3325D Boehringer Ingelheim Investigational Site
Nantes Cedex 1, France
352.2046.3332C Boehringer Ingelheim Investigational Site
Nîmes, France
352.2046.3332A Boehringer Ingelheim Investigational Site
Nîmes, France
352.2046.3332B Boehringer Ingelheim Investigational Site
Nîmes, France
352.2046.3324A Boehringer Ingelheim Investigational Site
Nîmes, France
352.2046.3331A Boehringer Ingelheim Investigational Site
Perpignan, France
352.2046.3331B Boehringer Ingelheim Investigational Site
Perpignan, France
352.2046.3331C Boehringer Ingelheim Investigational Site
Perpignan, France
352.2046.3329A Boehringer Ingelheim Investigational Site
Saint Laurent du Var, France
352.2046.3329B Boehringer Ingelheim Investigational Site
Saint Laurent du Var, France
352.2046.3302A Boehringer Ingelheim Investigational Site
Saint-Pierre cedex, France
352.2046.3302D Boehringer Ingelheim Investigational Site
Saint-Pierre cedex, France
352.2046.3302C Boehringer Ingelheim Investigational Site
Saint-Pierre cedex, France
352.2046.3302B Boehringer Ingelheim Investigational Site
Saint-Pierre cedex, France
352.2046.3337A Boehringer Ingelheim Investigational Site
Toulouse, France
352.2046.3336A Boehringer Ingelheim Investigational Site
Toulouse cedex 9, France
352.2046.3336B Boehringer Ingelheim Investigational Site
Toulouse cedex 9, France
352.2046.3336C Boehringer Ingelheim Investigational Site
Toulouse cedex 9, France
Germany
352.2046.49012 Boehringer Ingelheim Investigational Site
Berlin, Germany
352.2046.49020 Boehringer Ingelheim Investigational Site
Berlin, Germany
352.2046.49021 Boehringer Ingelheim Investigational Site
Berlin, Germany
352.2046.49008 Boehringer Ingelheim Investigational Site
Bochum, Germany
352.2046.49019 Boehringer Ingelheim Investigational Site
Cottbus, Germany
352.2046.49002 Boehringer Ingelheim Investigational Site
Donaustauf, Germany
352.2046.49025 Boehringer Ingelheim Investigational Site
Frankfurt, Germany
352.2046.49013 Boehringer Ingelheim Investigational Site
Frankfurt, Germany
352.2046.49023 Boehringer Ingelheim Investigational Site
Frankfurt/Main, Germany
352.2046.49024 Boehringer Ingelheim Investigational Site
Geesthacht, Germany
352.2046.49022 Boehringer Ingelheim Investigational Site
Gelnhausen, Germany
352.2046.49001 Boehringer Ingelheim Investigational Site
Großhansdorf, Germany
352.2046.49006 Boehringer Ingelheim Investigational Site
Heidelberg, Germany
352.2046.49014 Boehringer Ingelheim Investigational Site
Immenhausen, Germany
352.2046.49016 Boehringer Ingelheim Investigational Site
Kiel, Germany
352.2046.49003 Boehringer Ingelheim Investigational Site
Köln, Germany
352.2046.49004 Boehringer Ingelheim Investigational Site
Mainz, Germany
352.2046.49005 Boehringer Ingelheim Investigational Site
Marburg, Germany
352.2046.49015 Boehringer Ingelheim Investigational Site
München, Germany
Greece
352.2046.30012 Boehringer Ingelheim Investigational Site
Athens, Greece
352.2046.30004 Boehringer Ingelheim Investigational Site
Athens, Greece
352.2046.30005 Boehringer Ingelheim Investigational Site
Athens, Greece
352.2046.30007 Boehringer Ingelheim Investigational Site
Athens, Greece
352.2046.30008 Boehringer Ingelheim Investigational Site
Athens, Greece
352.2046.30011 Boehringer Ingelheim Investigational Site
Athens, Greece
352.2046.30003 Boehringer Ingelheim Investigational Site
Athens, Greece
352.2046.30006 Boehringer Ingelheim Investigational Site
Heraklion, Greece
352.2046.30009 Boehringer Ingelheim Investigational Site
Larisa, Greece
352.2046.30001 Boehringer Ingelheim Investigational Site
Thessaloniki, Greece
352.2046.30002 Boehringer Ingelheim Investigational Site
Thessaloniki, Greece
Hungary
352.2046.36003 Boehringer Ingelheim Investigational Site
Cegled, Hungary
352.2046.36002 Boehringer Ingelheim Investigational Site
Deszk, Hungary
352.2046.36004 Boehringer Ingelheim Investigational Site
Komarom, Hungary
352.2046.36006 Boehringer Ingelheim Investigational Site
Pecs, Hungary
352.2046.36001 Boehringer Ingelheim Investigational Site
Szarvas, Hungary
352.2046.36005 Boehringer Ingelheim Investigational Site
Szazhalombatta, Hungary
352.2046.36011 Boehringer Ingelheim Investigational Site
Szigetszentmiklos, Hungary
Italy
352.2046.39002 Boehringer Ingelheim Investigational Site
Catania, Italy
352.2046.39007 Boehringer Ingelheim Investigational Site
Cona, Italy
352.2046.39005 Boehringer Ingelheim Investigational Site
Foggia, Italy
352.2046.39003 Boehringer Ingelheim Investigational Site
Modena, Italy
352.2046.39006 Boehringer Ingelheim Investigational Site
Montescano (pv), Italy
352.2046.39001 Boehringer Ingelheim Investigational Site
Pisa, Italy
352.2046.39004 Boehringer Ingelheim Investigational Site
Sesto S. Giovanni (mi), Italy
352.2046.39008 Boehringer Ingelheim Investigational Site
Tradate (va), Italy
Netherlands
352.2046.31004 Boehringer Ingelheim Investigational Site
Heerlen, Netherlands
352.2046.31001 Boehringer Ingelheim Investigational Site
Leeuwarden, Netherlands
352.2046.31003 Boehringer Ingelheim Investigational Site
Rotterdam, Netherlands
352.2046.31002 Boehringer Ingelheim Investigational Site
Veldhoven, Netherlands
New Zealand
352.2046.64007 Boehringer Ingelheim Investigational Site
Auckland NZ, New Zealand
352.2046.64003 Boehringer Ingelheim Investigational Site
Christchurch, New Zealand
352.2046.64004 Boehringer Ingelheim Investigational Site
Dunedin, New Zealand
352.2046.64006 Boehringer Ingelheim Investigational Site
Hamilton, New Zealand
352.2046.64001 Boehringer Ingelheim Investigational Site
Newtown Wellington NZ, New Zealand
352.2046.64005 Boehringer Ingelheim Investigational Site
Otahuhu New Zealand, New Zealand
352.2046.64002 Boehringer Ingelheim Investigational Site
Tauranga, New Zealand
Philippines
352.2046.63001 Boehringer Ingelheim Investigational Site
Caloocan, Philippines
352.2046.63004 Boehringer Ingelheim Investigational Site
Manila, Philippines
352.2046.63003 Boehringer Ingelheim Investigational Site
Manila, Philippines
352.2046.63009 Boehringer Ingelheim Investigational Site
Muntinlupa, Philippines
352.2046.63005 Boehringer Ingelheim Investigational Site
Quezon, Philippines
352.2046.63007 Boehringer Ingelheim Investigational Site
Quezon, Philippines
352.2046.63006 Boehringer Ingelheim Investigational Site
Quezon City, Philippines
352.2046.63008 Boehringer Ingelheim Investigational Site
Quezon City, Philippines
Poland
352.2046.48006 Boehringer Ingelheim Investigational Site
Bytom, Poland
352.2046.48003 Boehringer Ingelheim Investigational Site
Ostrow Wielkopolska, Poland
352.2046.48001 Boehringer Ingelheim Investigational Site
Poznan, Poland
352.2046.48002 Boehringer Ingelheim Investigational Site
Poznan, Poland
352.2046.48009 Boehringer Ingelheim Investigational Site
Rzeszow, Poland
352.2046.48011 Boehringer Ingelheim Investigational Site
Tarnowskie Gory, Poland
352.2046.48005 Boehringer Ingelheim Investigational Site
Warsaw, Poland
352.2046.48007 Boehringer Ingelheim Investigational Site
Wroclaw, Poland
Russian Federation
352.2046.07011 Boehringer Ingelheim Investigational Site
Ekaterinburg, Russian Federation
352.2046.07006 Boehringer Ingelheim Investigational Site
Ivanovo, Russian Federation
352.2046.07008 Boehringer Ingelheim Investigational Site
Moscow, Russian Federation
352.2046.07009 Boehringer Ingelheim Investigational Site
Moscow, Russian Federation
352.2046.07002 Boehringer Ingelheim Investigational Site
Samara, Russian Federation
352.2046.07003 Boehringer Ingelheim Investigational Site
Saratov, Russian Federation
352.2046.07001 Boehringer Ingelheim Investigational Site
St. Petersburg, Russian Federation
352.2046.07004 Boehringer Ingelheim Investigational Site
Yaroslavl, Russian Federation
352.2046.07005 Boehringer Ingelheim Investigational Site
Yaroslavl, Russian Federation
South Africa
352.2046.27006 Boehringer Ingelheim Investigational Site
Amanzimtoti, South Africa
352.2046.27002 Boehringer Ingelheim Investigational Site
Bellville, South Africa
352.2046.27001 Boehringer Ingelheim Investigational Site
Cape Town, South Africa
352.2046.27003 Boehringer Ingelheim Investigational Site
Cape Town, South Africa
352.2046.27007 Boehringer Ingelheim Investigational Site
Pretoria, South Africa
352.2046.27005 Boehringer Ingelheim Investigational Site
Somerset West, South Africa
352.2046.27004 Boehringer Ingelheim Investigational Site
Tygerberg, South Africa
Spain
352.2046.34008 Boehringer Ingelheim Investigational Site
Badajoz, Spain
352.2046.34002 Boehringer Ingelheim Investigational Site
Barakaldo (Bilbao), Spain
352.2046.34001 Boehringer Ingelheim Investigational Site
Barcelona, Spain
352.2046.34004 Boehringer Ingelheim Investigational Site
Barcelona, Spain
352.2046.34009 Boehringer Ingelheim Investigational Site
Hospitalet de Llobregat, Spain
352.2046.34006 Boehringer Ingelheim Investigational Site
Palma de Mallorca, Spain
352.2046.34010 Boehringer Ingelheim Investigational Site
Pozuelo de Alarcón, Spain
352.2046.34013 Boehringer Ingelheim Investigational Site
Salt (Girona), Spain
352.2046.34011 Boehringer Ingelheim Investigational Site
Sevilla, Spain
Taiwan
352.2046.88606 Boehringer Ingelheim Investigational Site
Kaohsiung, Taiwan
352.2046.88604 Boehringer Ingelheim Investigational Site
Taichung, Taiwan
352.2046.88601 Boehringer Ingelheim Investigational Site
Taipei, Taiwan
352.2046.88603 Boehringer Ingelheim Investigational Site
Taipei, Taiwan
352.2046.88607 Boehringer Ingelheim Investigational Site
Taiwan, Taiwan
352.2046.88608 Boehringer Ingelheim Investigational Site
Taiwan, Taiwan
Tunisia
352.2046.2162A Boehringer Ingelheim Investigational Site
Ariana, Tunisia
352.2046.2161A Boehringer Ingelheim Investigational Site
Ariana, Tunisia
352.2046.2165A Boehringer Ingelheim Investigational Site
Sfax, Tunisia
352.2046.2164A Boehringer Ingelheim Investigational Site
Sousse, Tunisia
352.2046.2163A Boehringer Ingelheim Investigational Site
Tunis, Tunisia
Turkey
352.2046.90009 Boehringer Ingelheim Investigational Site
Ankara, Turkey
352.2046.90019 Boehringer Ingelheim Investigational Site
Ankara, Turkey
352.2046.90016 Boehringer Ingelheim Investigational Site
Bursa, Turkey
352.2046.90010 Boehringer Ingelheim Investigational Site
Denizli, Turkey
352.2046.90003 Boehringer Ingelheim Investigational Site
Istanbul, Turkey
352.2046.90004 Boehringer Ingelheim Investigational Site
Istanbul, Turkey
352.2046.90006 Boehringer Ingelheim Investigational Site
Istanbul, Turkey
352.2046.90008 Boehringer Ingelheim Investigational Site
Istanbul, Turkey
352.2046.90012 Boehringer Ingelheim Investigational Site
Istanbul, Turkey
352.2046.90017 Boehringer Ingelheim Investigational Site
Istanbul, Turkey
352.2046.90011 Boehringer Ingelheim Investigational Site
Izmir, Turkey
352.2046.90014 Boehringer Ingelheim Investigational Site
Izmir, Turkey
352.2046.90018 Boehringer Ingelheim Investigational Site
Izmir, Turkey
352.2046.90005 Boehringer Ingelheim Investigational Site
Izmit, Turkey
352.2046.90007 Boehringer Ingelheim Investigational Site
Kayseri, Turkey
352.2046.90001 Boehringer Ingelheim Investigational Site
Mersin, Turkey
352.2046.90002 Boehringer Ingelheim Investigational Site
Samsun, Turkey
Ukraine
352.2046.38007 Boehringer Ingelheim Investigational Site
Ivano-Frankivsk, Ukraine
352.2046.38002 Boehringer Ingelheim Investigational Site
Kharkiv, Ukraine
352.2046.38003 Boehringer Ingelheim Investigational Site
Kharkov, Ukraine
352.2046.38006 Boehringer Ingelheim Investigational Site
Kiev, Ukraine
352.2046.38004 Boehringer Ingelheim Investigational Site
Kiev, Ukraine
352.2046.38005 Boehringer Ingelheim Investigational Site
Vinnitsa, Ukraine
352.2046.38001 Boehringer Ingelheim Investigational Site
Vinnytsya, Ukraine
United Kingdom
352.2046.44008 Boehringer Ingelheim Investigational Site
Baillieston, Glasgow, United Kingdom
352.2046.44009 Boehringer Ingelheim Investigational Site
Barnsley, United Kingdom
352.2046.44018 Boehringer Ingelheim Investigational Site
Belfast, United Kingdom
352.2046.44010 Boehringer Ingelheim Investigational Site
Birmingham, United Kingdom
352.2046.44003 Boehringer Ingelheim Investigational Site
Cambridge, United Kingdom
352.2046.44026 Boehringer Ingelheim Investigational Site
Chertsey, United Kingdom
352.2046.44006 Boehringer Ingelheim Investigational Site
Chesterfield, United Kingdom
352.2046.44012 Boehringer Ingelheim Investigational Site
Cottingham, Hull, United Kingdom
352.2046.44028 Boehringer Ingelheim Investigational Site
Inverness, United Kingdom
352.2046.44016 Boehringer Ingelheim Investigational Site
Isleworth, United Kingdom
352.2046.44002 Boehringer Ingelheim Investigational Site
Liverpool, United Kingdom
352.2046.44001 Boehringer Ingelheim Investigational Site
London, United Kingdom
352.2046.44017 Boehringer Ingelheim Investigational Site
Norwich, United Kingdom
352.2046.44021 Boehringer Ingelheim Investigational Site
Sheffield, United Kingdom
352.2046.44019 Boehringer Ingelheim Investigational Site
Sunderland, United Kingdom
352.2046.44025 Boehringer Ingelheim Investigational Site
Windsor, 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
ClinicalTrials.gov Identifier: NCT00975195     History of Changes
Other Study ID Numbers: 352.2046, 2007-002522-29
Study First Received: September 10, 2009
Results First Received: December 23, 2014
Last Updated: February 9, 2015
Health Authority: Australia: Dept of Health and Ageing Therapeutic Goods Admin
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Brazil: National Health Surveillance Agency
Bulgaria: Bulgarian Drug Agency, BG-1504 Sofia
China: Food and Drug Administration
Denmark: The Danish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Great Britain: MHRA
Greece: Ethics Committee
Hungary: National Institute of Pharmacy, H-1051 Budapest
Italy: Ethics Committee
Netherlands: Central Committee Research Involving Human Subjects
New Zealand: Multicentre Ethics Committee/Medsafe
Philippines: Bureau of Food and Drugs
Poland: Registration Medicinal Product Medical Device Biocidal Product
Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow
South Africa: Medicines Control Council
Spain: Spanish Agency of Medicines
Taiwan: Department of Health
Tunisia: Office of Pharmacies and Medicines
Turkey: Ministry of Health Central Ethics Committee
Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine)

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Albuterol
Fluticasone
Salmeterol
Tiotropium
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Allergic Agents
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Cholinergic Agents
Cholinergic Antagonists
Dermatologic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Parasympatholytics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents

ClinicalTrials.gov processed this record on August 31, 2015