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Efficacy and Safety of 2 Doses of Tiotropium Respimat® Compared to Placebo in Children With Moderate Persistent Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01634139
Recruitment Status : Completed
First Posted : July 6, 2012
Results First Posted : July 12, 2016
Last Update Posted : July 12, 2016
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
The overall purpose of the trial is to evaluate efficacy and safety of tiotropium inhalation solution delivered via Respimat® inhaler (2.5 mcg and 5 mcg once daily in the evening) over 48 weeks, compared to placebo, in children (6 to 11 years old) with moderate persistent asthma.

Condition or disease Intervention/treatment Phase
Asthma Drug: Tiotropium low dose QD Drug: Tiotropium high dose QD Drug: Placebo Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 403 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate Efficacy and Safety of Tiotropium Inhalation Solution (2.5 mcg and 5 mcg) Delivered Via Respimat® Inhaler Once Daily in the Evening Over 48 Weeks in Children (6 to 11 Years Old) With Moderate Persistent Asthma
Study Start Date : July 2012
Actual Primary Completion Date : June 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: Tiotropium high dose QD Drug: Tiotropium high dose QD
2 actuations once daily in the evening

Experimental: Tiotropium low dose QD Drug: Tiotropium low dose QD
2 actuations once daily in the evening

Experimental: Placebo QD Drug: Placebo
2 actuations once daily in the evening




Primary Outcome Measures :
  1. FEV1 Peak (0-3h) Change From Baseline [ Time Frame: Baseline and 24 Weeks. ]

    Change from baseline in peak forced expiratory volume (FEV) in 1 second within the first 3 hours (h) post dosing (FEV1 peak(0-3h)) measured at week 24.

    Measured values presented are actually adjusted means.

    The number of participants analysed displays the number of participants with available data at the timepoint of interest.



Secondary Outcome Measures :
  1. Trough FEV1 Change From Baseline [ Time Frame: Baseline and Week 24, Baseline and Week 48. ]

    Change from Baseline in Trough (pre-dose) Forced Expiratory Volume (FEV) in 1 second (FEV1) measured at week 24 and 48.

    Measured values presented are actually adjusted means.

    The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint.


  2. FEV1 Peak (0-3h) at Week 48 Change From Baseline [ Time Frame: Baseline and Week 48. ]

    Change from baseline in peak forced expiratory volume (FEV) in 1 second within the first 3 hours (h) post dosing (FEV1 peak(0-3h)) measured at week 48.

    Measured values presented are actually adjusted means.

    The number of participants analysed displays the number of participants with available data at the timepoint of interest.


  3. FEV1 AUC (0-3h) Change From Baseline [ Time Frame: Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at week 24 ]

    Change from baseline of area under the curve (AUC) from 0 to 3 hours for FEV1 (FEV1 AUC (0-3h)) after 24 weeks of treatment. The AUC was calculated by using the trapezoidal rule divided by the observation time (3h).

    Measured values presented are actually adjusted means.

    The number of participants analysed displays the number of participants with available data at the timepoint of interest.


  4. FEV1 Change From Baseline at Each Individual Timepoint [ Time Frame: Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 24 weeks ]

    FEV1 change from baseline to week 24 at each individual timepoint.

    The measured values presented are actually adjusted means.

    The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint.


  5. FVC Peak(0-3h) Change From Baseline [ Time Frame: Baseline and Week 24, Baseline and Week 48. ]

    Change from baseline in Maximum forced vital capacity (FVC) measured within the first 3 hours after administration of trial medication (FVC peak(0-3h)) after 24 and 48 Weeks of treatment.

    Measured values presented are actually adjusted means.

    The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint.


  6. Trough FVC Change From Baseline [ Time Frame: Baseline and Week 24, Baseline and Week 48 ]

    Change from baseline in Trough (pre-dose) FVC measured at week 24 and 48.

    Measured values presented are actually adjusted means.

    The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint.


  7. FVC AUC (0-3h) Change From Baseline [ Time Frame: Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 24 weeks ]

    Change from baseline of area under the curve (AUC) from 0 to 3 hours for FVC (Forced vital capacity) (FVC AUC (0-3h)) after 24 weeks of treatment. The AUC was calculated by using the trapezoidal rule divided by the observation time (3h).

    Measured values presented are actually adjusted means.

    The number of participants analysed displays the number of participants with available data at the timepoint of interest.


  8. FVC Change From Baseline at Each Individual Timepoint [ Time Frame: Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at Week 24 ]

    FVC change from baseline to week 24 at each individual timepoint.

    The measured values presented are actually adjusted means

    The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint.


  9. Use of PRN (Pro re Nata) Rescue Medication Per Day [ Time Frame: Baseline and Week 24, Baseline and Week 48. ]

    Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used per day (24 hour period) based on the weekly mean at weeks 24 and 48.

    The measured values presented are actually adjusted means.

    The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint.


  10. Use of PRN Rescue Medication During Daytime [ Time Frame: Baseline and Week 24, Baseline and Week 48. ]

    Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used during daytime based on the weekly mean at weeks 24 and 48.

    Measured values presented are actually adjusted means

    The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint.


  11. Use of PRN Rescue Medication During Nighttime [ Time Frame: Baseline and Week 24, Baseline and Week 48. ]

    Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used during nighttime based on the weekly mean at weeks 24 and 48.

    Measured values presented are actually adjusted means.

    The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint.


  12. Peak Expiratory Flow (PEF) a.m. Change From Baseline [ Time Frame: Baseline and Week 24, Baseline and Week 48. ]

    Change from baseline in the morning (a.m.) peak expiratory flow based on the weekly mean at weeks 24 and 48.

    Measured values presented are actually adjusted means.

    The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint.


  13. PEF p.m. Change From Baseline [ Time Frame: Baseline and Week 24, Baseline and Week 48. ]

    Change from baseline in the evening (p.m.) peak expiratory flow based on the weekly mean at weeks 24 and 48.

    Measured values presented are actually adjusted means.

    The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint.


  14. PEF Variability Change From Baseline [ Time Frame: Baseline and Week 24, Baseline and Week 48. ]

    Change from baseline in the peak expiratory flow variability based on the weekly mean at week 24 and 48.

    Measured values presented are actually adjusted means.

    The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint.


  15. FEV1 a.m Change From Baseline [ Time Frame: Baseline and Week 24, Baseline and Week 48. ]

    Change from baseline in morning (a.m.) FEV1 based on the weekly mean at week 24 and 48.

    The measured values presented are actually adjusted means.

    The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint.


  16. FEV1 p.m. Change From Baseline [ Time Frame: Baseline and Week 24, Baseline and Week 48. ]

    Change from baseline in evening (p.m.) FEV1 based on the weekly mean at week 24 and 48.

    Measured values presented are actually adjusted means.

    The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint.


  17. ACQ−IA Total Score [ Time Frame: Weeks 24 and 48. ]

    Interviewer Administered Asthma Control Questionnaire (ACQ-IA) total score after 24 and 48 weeks of treatment.

    The ACQ-IA is a scale containing 7 questions. Each question has a 7 point scale which ranges from 0 to 6. A score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment. ACQ-IA total score is calculated as the mean of the responses to all 7 questions.

    The measured values presented are actually adjusted means.

    The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint.


  18. ACQ−IA Responder Analysis [ Time Frame: Weeks 24 and 48 ]

    Responder categories based on the ACQ-IA total score after 24 and 48 weeks of treatment. Analysis was performed using the following categories and definitions: responder (change from trial baseline ≤-0.5), no change (-0.5 <change from trial baseline <0.5) and worsening (change from trial baseline ≥0.5). No statistical testing was performed for ACQ-IA total score responders.

    The ACQ-IA is a scale containing 7 questions, each question has a 7-point scale which ranges from 0 to 6; a score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment.


  19. PAQLQ(S) Total Score [ Time Frame: Weeks 24 and 48. ]

    Standardised Paediatric Asthma Quality of Life Questionnaire (PAQLQ(S)) total score at weeks 24 and 48.

    The PAQLQ(S) is 23 questions on a 7-point scale, ranging from 1 (worst control) to 7 (best control). Total Score is calculated as mean of all 23 questions.

    The measured values presented are actually adjusted means.

    The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint.


  20. PAQLQ(S) Symptom Domain Score [ Time Frame: Weeks 24 and 48. ]

    PAQLQ(S) symptom domain score at weeks 24 and 48. The PAQLQ(S) is 23 questions on a 7-point scale, ranging from 1 (worst control) to 7 (best control). The individual domain score was calculated as the mean of the items in the domain.

    The measured values presented are actually adjusted means.

    The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint.


  21. PAQLQ(S) Activity Limitation Domain Score [ Time Frame: Weeks 24 and 48. ]

    PAQLQ(S) activity limitation domain score at weeks 24 and 48. The PAQLQ(S) is 23 questions on a 7-point scale, ranging from 1 (worst control) to 7 (best control). The individual domain score is calculated as the mean of the items in this domain.

    The measured values presented are actually adjusted means.

    The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint.


  22. PAQLQ(S) Emotional Function Domain Score [ Time Frame: Weeks 24 and 48. ]

    PAQLQ(S) emotional function domain score at weeks 24 and 48. The PAQLQ(S) is 23 questions on a 7-point scale, ranging from 1 (worst control) to 7 (best control). The individual domain score is calculated as the mean of the items in this domain.

    The measured values presented are actually adjusted means.

    The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint.


  23. Responders in PAQLQ(S) at Weeks 24 and 48 [ Time Frame: Weeks 24 and 48. ]

    Responders in PAQLQ(S) at weeks 24 and 48. Analysis was performed using the following categories and definitions: responder (change from trial baseline ≥0.5), no change (-0.5 <change from trial baseline <0.5) and worsening (change from trial baseline ≤-0.5). No statistical testing was performed for PAQLQ(S) total score responders.

    The PAQLQ(S) is 23 questions on a 7-point scale, ranging from 1 (worst control) to 7 (best control).


  24. Change From Baseline in Nighttime Awakenings [ Time Frame: Baseline and Week 24, Baseline and Week 48. ]

    Change from baseline in nighttime awakenings based on the weekly mean at weeks 24 and 48.

    Nighttime awakenings was assessed by the question "Did you wake up during the night due to your asthma?" from the e-diary. Scores range from 1 (did not wake up) to 5 (was awake all night).

    Measured values presented are actually adjusted means.

    The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint.


  25. Change From Baseline in Morning Asthma Symptoms [ Time Frame: Baseline and Week 24, Baseline and Week 48. ]

    Change from baseline in morning asthma symptoms based on the weekly mean at weeks 24 and 48.

    Morning asthma symptoms was assessed by the question "how were your asthma symptoms this morning?" from the e-diary. Scores range from 1 (no asthma symptoms) to 5 (very severe asthma symptoms).

    Measured values presented are actually adjusted means.

    The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint.


  26. Change From Baseline in Daytime Asthma Symptoms [ Time Frame: Baseline and Week 24, Baseline and Week 48. ]

    Change from baseline in daytime asthma symptoms based on the weekly mean at weeks 24 and 48.

    Daytime asthma symptoms was assessed by the question "how were your asthma symptoms during the day?" from the e-diary. Scores range from 1 (no asthma symptoms) to 5 (very severe asthma symptoms).

    Measured values presented are actually adjusted means.

    The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint.


  27. Change From Baseline in Daytime Activity Limitations [ Time Frame: Baseline and Week 24, Baseline and Week 48. ]

    Change from baseline in daytime activity limitations based on the weekly mean at weeks 24 and 48.

    Daytime activity limitations was assessed by the question "how limited were you in your activities today because of your asthma?" from the e-diary. Scores range from 1 (not limited) to 5 (totally limited).

    Measured values presented are actually adjusted means.

    The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint.


  28. Change From Baseline in Daytime Experiences of Shortness of Breath [ Time Frame: Baseline and Week 24, Baseline and Week 48. ]

    Change from baseline in daytime experiences of shortness of breath based on the weekly mean at weeks 24 and 48.

    Daytime experiences of shortness of breath was assessed by the question "how much shortness of breath did you experience during the day" from the e-diary. Scores range from 1 (none) to 5 (a very great deal).

    Measured values presented are actually adjusted means.

    The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint.


  29. Change From Baseline in Daytime Experiences of Wheeze or Cough [ Time Frame: Baseline and Week 24, Baseline and Week 48. ]

    Change from baseline in daytime experiences of wheeze or cough based on the weekly mean at weeks 24 and 48.

    Daytime experiences of wheeze or cough was assessed by the question "did you experience wheeze or cough during the day?" from the e-diary. Scores range from 1 (not at all) to 5 (all the time).

    Measured values presented are actually adjusted means.

    The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint.


  30. Change From Baseline in Asthma Symptom-free Days [ Time Frame: Baseline and Week 24, Baseline and Week 48. ]

    Change from baseline in asthma symptom-free days based on the weekly mean at weeks 24 and 48.

    A day was considered as an asthma symptom-free day if there were no symptoms reported via the e-Diary (electronic diary) and no use of rescue medication reported via the eDiary during that day.

    Measured values presented are actually adjusted means.

    The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint.




Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

Inclusion criteria are:

  1. All patients' parent(s) (or legal guardian) must sign and date an informed consent prior to participation in the trial. In addition, an informed assent suitable for this age group has to be obtained from patients. A separate informed consent/assent is required for pharmacogenomic sampling.
  2. Male or female patients between 6 and 11 years of age.
  3. All patients must have at least a 6-month history of asthma.
  4. All patients must have been on maintenance treatment with an inhaled corticosteroid at a stable medium dose, either as mono treatment or in combination with another controller medication, for at least 4 weeks before Visit 1. While the LTRA is permitted throughout the trial, the LABA has to be stopped at least 24 hours prior to Visit 1, as no LABAs are permitted during screening and treatment period of this trial.
  5. All patients must be symptomatic (partly controlled) at Visit 1 and prior to randomisation at Visit 2 as defined by an Asthma Control Questionnaire (ACQ-IA) mean score >= 1.5.
  6. All patients must have a pre-bronchodilator forced expiratory volume in one second (FEV1) >= 60% and =< 90% of predicted normal at Visit 1.
  7. Variation of absolute FEV1 values of Visit 1 (pre-bronchodilator, considered as 100%) as compared to Visit 2 (pre-dose) must be within ± 30%.
  8. All patients must confirm the diagnosis of asthma by bronchodilator reversibility at Visit 1, resulting in an increase in FEV1 of >= 12%, 15 to 30 minutes after 200 mcg salbutamol/albuterol.
  9. Patients must be able to use the Respimat inhaler correctly.
  10. Patients must be able to perform all trial related procedures including technically acceptable pulmonary function tests and use of electronic diary/peak flow meter (diary compliance of at least 80% is required).

Exclusion criteria:

Exclusion criteria are:

  1. Patients with a significant disease other than asthma.
  2. Patients with a clinically relevant abnormal haematology or blood chemistry at screening.
  3. Patients with a history of congenital or acquired heart disease, or patients who have been hospitalized for cardiac syncope or failure during 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 a malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years.
  6. Patients with known active tuberculosis.
  7. Patients who have undergone thoracotomy with pulmonary resection.
  8. Patients who are currently in a pulmonary rehabilitation program or have completed a pulmonary rehabilitation program in the six weeks prior to Visit 1.
  9. Patients with known hypersensitivity to anticholinergic drugs, BAC, EDTA or any other components of the inhalation solution used with the Respimat inhaler.
  10. Pregnant or nursing female patients, including postmenarchal girl with a positive urine pregnancy test at Visit 1.
  11. Postmenarchal girl of child-bearing potential not using a highly effective method of birth control.
  12. Patients who have been treated with anti-IgE treatment within the last six months prior to Visit 1 and/or during the screening period.
  13. Patients who have been treated with systemic corticosteroids within four weeks prior to Visit 1.
  14. Patients who have been treated with systemic beta-adrenergics within four weeks prior to Visit 1.
  15. Patients who have been treated with oral beta-blocker medication within four weeks prior to Visit 1 and/or during the screening period.
  16. Patients who have been treated with inhaled long-acting anticholinergics or systemic anticholinergic treatment within four weeks prior to Visit 1 and/or during the screening period or who have been treated with inhaled short-acting anticholinergics within two weeks prior to Visit 1.
  17. Patients who have been treated with long-acting theophylline preparations within four weeks prior to Visit 1 and/or during the screening period or who have been treated with short-acting theophylline preparations within two weeks prior to Visit 1.
  18. Patients who have been treated with non-approved and according to international guidelines not recommended experimental drugs for routine asthma therapy within four weeks prior to Visit 1 and/or during the screening period.
  19. Patients who have taken an investigational drug within six half lives according to the investigator's information, or four weeks (whichever is greater) prior to Visit 1 and/or during the screening period.
  20. Patients who have previously been randomised in this trial or are currently participating in another trial.
  21. Patients with any acute asthma exacerbation or respiratory tract infection in the four weeks prior to Visit 1 and /or in four weeks prior to Visit 2. In case of an asthma deterioration occurring in the four weeks prior to Visit 1 and/or in the four weeks prior to Visit 2, the visit must be postponed.
  22. Patients requiring six or more puffs of rescue medication per day on more than two consecutive days in the four weeks prior to Visit 1 and/or in the four weeks prior to Visit 2. In case of an asthma deterioration occurring in the four weeks prior to Visit 1 and/or in the four weeks prior to Visit 2, the visit must be postponed.
  23. Patients who are unable to comply with medication restrictions prior to Visit 1 and or Visit 2.
  24. Patients with a known narrow-angle glaucoma, or any other disease where anticholinergic treatment is contraindicated.
  25. Patients with moderate to severe renal impairment, as defined by a creatinine clearance <50 mL/min/1.73 m2 BSA, as tiotropium is a predominantly renally excreted drug.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01634139


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Locations
Layout table for location information
United States, Missouri
205.445.01002 Boehringer Ingelheim Investigational Site
Columbia, Missouri, United States
United States, Ohio
205.445.01001 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio, United States
United States, Oklahoma
205.445.01010 Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma, United States
United States, South Carolina
205.445.01006 Boehringer Ingelheim Investigational Site
Charleston, South Carolina, United States
United States, Texas
205.445.01012 Boehringer Ingelheim Investigational Site
Arlington, Texas, United States
205.445.01004 Boehringer Ingelheim Investigational Site
El Paso, Texas, United States
Bulgaria
205.445.35901 Boehringer Ingelheim Investigational Site
Sofia, Bulgaria
205.445.35902 Boehringer Ingelheim Investigational Site
Sofia, Bulgaria
205.445.35903 Boehringer Ingelheim Investigational Site
Sofia, Bulgaria
205.445.35904 Boehringer Ingelheim Investigational Site
Sofia, Bulgaria
205.445.35905 Boehringer Ingelheim Investigational Site
Sofia, Bulgaria
Canada, Ontario
205.445.02003 Boehringer Ingelheim Investigational Site
London, Ontario, Canada
Canada, Quebec
205.445.02001 Boehringer Ingelheim Investigational Site
Sherbrooke, Quebec, Canada
Germany
205.445.49012 Boehringer Ingelheim Investigational Site
Berlin, Germany
205.445.49015 Boehringer Ingelheim Investigational Site
Berlin, Germany
205.445.49001 Boehringer Ingelheim Investigational Site
Bochum, Germany
205.445.49007 Boehringer Ingelheim Investigational Site
Dresden, Germany
205.445.49004 Boehringer Ingelheim Investigational Site
Ettenheim, Germany
205.445.49009 Boehringer Ingelheim Investigational Site
Koblenz, Germany
205.445.49014 Boehringer Ingelheim Investigational Site
Marburg, Germany
Guatemala
205.445.50201 Boehringer Ingelheim Investigational Site
Guatemala, Guatemala
205.445.50202 Boehringer Ingelheim Investigational Site
Guatemala, Guatemala
205.445.50203 Boehringer Ingelheim Investigational Site
Guatemala, Guatemala
205.445.50204 Boehringer Ingelheim Investigational Site
Guatemala, Guatemala
205.445.50205 Boehringer Ingelheim Investigational Site
Guatemala, Guatemala
Hungary
205.445.36003 Boehringer Ingelheim Investigational Site
Ajka, Hungary
205.445.36001 Boehringer Ingelheim Investigational Site
Budapest, Hungary
205.445.36002 Boehringer Ingelheim Investigational Site
Dombovar, Hungary
Korea, Republic of
205.445.82003 Boehringer Ingelheim Investigational Site
Guri, Korea, Republic of
205.445.82002 Boehringer Ingelheim Investigational Site
Incheon, Korea, Republic of
205.445.82001 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
205.445.82005 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
205.445.82006 Boehringer Ingelheim Investigational Site
Sungnam, Korea, Republic of
Latvia
205.445.37104 Boehringer Ingelheim Investigational Site
Adazi, Latvia
205.445.37101 Boehringer Ingelheim Investigational Site
Baldone, Latvia
205.445.37106 Boehringer Ingelheim Investigational Site
Balvi, Latvia
205.445.37108 Boehringer Ingelheim Investigational Site
Daugavpils, Latvia
205.445.37102 Boehringer Ingelheim Investigational Site
Ogre, Latvia
205.445.37107 Boehringer Ingelheim Investigational Site
Rezekne, Latvia
205.445.37103 Boehringer Ingelheim Investigational Site
Riga, Latvia
205.445.37105 Boehringer Ingelheim Investigational Site
Riga, Latvia
Lithuania
205.445.37002 Boehringer Ingelheim Investigational Site
Siauliai, Lithuania
205.445.37005 Boehringer Ingelheim Investigational Site
Utena, Lithuania
205.445.37003 Boehringer Ingelheim Investigational Site
Vilnius, Lithuania
Norway
205.445.47002 Boehringer Ingelheim Investigational Site
Oslo, Norway
Portugal
205.445.35108 Boehringer Ingelheim Investigational Site
Amadora, Portugal
205.445.35106 Boehringer Ingelheim Investigational Site
Aveiro, Portugal
205.445.35101 Boehringer Ingelheim Investigational Site
Lisboa, Portugal
205.445.35102 Boehringer Ingelheim Investigational Site
Lisboa, Portugal
205.445.35107 Boehringer Ingelheim Investigational Site
Lisboa, Portugal
205.445.35103 Boehringer Ingelheim Investigational Site
Porto, Portugal
205.445.35105 Boehringer Ingelheim Investigational Site
Porto, Portugal
Romania
205.445.40001 Boehringer Ingelheim Investigational Site
Bucharest, Romania
205.445.40004 Boehringer Ingelheim Investigational Site
Bucharest, Romania
205.445.40003 Boehringer Ingelheim Investigational Site
Cluj Napoca, Romania
Russian Federation
205.445.70002 Boehringer Ingelheim Investigational Site
Moscow, Russian Federation
205.445.70005 Boehringer Ingelheim Investigational Site
Moscow, Russian Federation
205.445.70008 Boehringer Ingelheim Investigational Site
Moscow, Russian Federation
205.445.70011 Boehringer Ingelheim Investigational Site
Moscow, Russian Federation
205.445.70001 Boehringer Ingelheim Investigational Site
St. Petersburg, Russian Federation
205.445.70003 Boehringer Ingelheim Investigational Site
St. Petersburg, Russian Federation
205.445.70004 Boehringer Ingelheim Investigational Site
St. Petersburg, Russian Federation
205.445.70009 Boehringer Ingelheim Investigational Site
St. Petersburg, Russian Federation
205.445.70010 Boehringer Ingelheim Investigational Site
Yaroslavl, Russian Federation
Sweden
205.445.46001 Boehringer Ingelheim Investigational Site
Stockholm, Sweden
Ukraine
205.445.38017 Boehringer Ingelheim Investigational Site
Chernivtsi, Ukraine
205.445.38003 Boehringer Ingelheim Investigational Site
Dnipropetrovsk, Ukraine
205.445.38005 Boehringer Ingelheim Investigational Site
Donetsk, Ukraine
205.445.38011 Boehringer Ingelheim Investigational Site
Donetsk, Ukraine
205.445.38008 Boehringer Ingelheim Investigational Site
Kharkiv, Ukraine
205.445.38004 Boehringer Ingelheim Investigational Site
Kiev, Ukraine
205.445.38012 Boehringer Ingelheim Investigational Site
Kriviy Rig, Ukraine
205.445.38001 Boehringer Ingelheim Investigational Site
Lviv, Ukraine
205.445.38009 Boehringer Ingelheim Investigational Site
Lviv, Ukraine
205.445.38016 Boehringer Ingelheim Investigational Site
Odessa, Ukraine
205.445.38006 Boehringer Ingelheim Investigational Site
Vinnytsya, Ukraine
205.445.38010 Boehringer Ingelheim Investigational Site
Zaporizhya, Ukraine
205.445.38002 Boehringer Ingelheim Investigational Site
Zaporizhzhya, Ukraine
United Kingdom
205.445.44001 Boehringer Ingelheim Investigational Site
London, United Kingdom
Sponsors and Collaborators
Boehringer Ingelheim
Pfizer
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01634139     History of Changes
Other Study ID Numbers: 205.445
2011-001758-26 ( EudraCT Number: EudraCT )
First Posted: July 6, 2012    Key Record Dates
Results First Posted: July 12, 2016
Last Update Posted: July 12, 2016
Last Verified: June 2016

Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Tiotropium Bromide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action