Randomised, Double- Blind, Cross-over Efficacy and Safety Comparison of Three Different Doses of Tiotropium Administered Once Daily Versus Placebo in Patients With Moderate Persistent Asthma.

• ClinicalTrials.gov Identifier: NCT01233284
• Recruitment Status: Completed
• First Posted: November 3, 2010
• Results First Posted: January 21, 2013
• Last Update Posted: December 24, 2013
• Sponsor: Boehringer Ingelheim
• Collaborator: Pfizer
• Information provided by (Responsible Party): Boehringer Ingelheim

Tracking Information

• First Submitted Date: November 2, 2010
• First Posted Date: November 3, 2010
• Results First Submitted Date: December 14, 2012
• Results First Posted Date: January 21, 2013
• Last Update Posted Date: December 24, 2013
• Study Start Date: November 2010
• Actual Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 12, 2013)

Forced Expiratory Volume in One Second (FEV1) Peak Within 0-3 Hours Post-dose Response [ Time Frame: 10 minutes (min) before drug administration and 30 min, 1h, 2h, 3h after drug administration ]

Mixed model repeated measurement (MMRM) results. Response was defined as change from baseline at the end of of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline.

• Original Primary Outcome Measures (submitted: November 2, 2010): Forced Expiratory Volume in one second [FEV1] Peak 0-3hrs [FEV1 Peak0-3] response determined at the end of each of the four 4-week treatment periods. [ Time Frame: 4 weeks ]

Current Secondary Outcome Measures (submitted: September 12, 2013)

• Trough FEV1 Response [ Time Frame: Baseline and 4 weeks ]
  MMRM results. Response was defined as change from baseline at the end of of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. Trough FEV1 was measured just prior to the last administration of randomised treatment.
• FEV1 Area Under the Curve 0-3 Hours (AUC0-3h) Response [ Time Frame: 10 minutes (min) before drug administration and 30 min, 1h, 2h, 3h after drug administration ]
  MMRM results. Response was defined as change from baseline at the end of of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. FEV1 AUC0-3h was calculated using the trapezoidal rule divided by the observation time (3 hours) to report in litres.
• Forced Vital Capacity (FVC) Peak Within 0-3 Hours Post-dose Response [ Time Frame: 10 minutes (min) before drug administration and 30 min, 1h, 2h, 3h after drug administration ]
  MMRM results. Response was defined as change from baseline at the end of of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline.
• Trough FVC Response [ Time Frame: Baseline and 4 weeks ]
  MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. Trough FVC was measured just prior to the last administration of randomised treatment.
• FVC AUC0-3h Response [ Time Frame: 10 minutes (min) before drug administration and 30 min, 1h, 2h, 3h after drug administration ]
  MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. FVC AUC0-3h was calculated using the trapezoidal rule divided by the observation time (3 hours) to report in litres.
• Individual FEV1 Over Time (at Each Timepoint at Visits) Response [ Time Frame: Baseline and 4 weeks ]
  MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline.
• Individual FVC Over Time (at Each Timepoint at Visits) Response [ Time Frame: Baseline and 4 weeks ]
  MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline.
• Individual Peak Expiratory Flow (PEF) Over Time (at Each Timepoint at Visits) Response [ Time Frame: Baseline and 4 weeks ]
  MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline.
• Mean Pre-dose Morning PEF (PEF a.m.) Response During the Last Week on Treatment [ Time Frame: Baseline and 4 weeks ]
  MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. Weekly means obtained during the last week of each period of randomised treatment will be compared (measured by patients at home using the AM2+ device).
• Mean Pre-dose Evening PEF (PEF p.m.) Response During the Last Week on Treatment [ Time Frame: Baseline and 4 weeks ]
  MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. Weekly means obtained during the last week of each period of randomised treatment will be compared (measured by patients at home using the AM2+ device).
• PEF Variability Response (Last Week on Treatment) [ Time Frame: Baseline and 4 weeks ]
  MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. PEF variability is the absolute difference between morning and evening PEF value divided by the mean of these two values, expressed as a percent . Weekly means obtained during the last week of each period of randomised treatment will be compared.
• Mean Number of Puffs of Rescue Medication During the Whole Day (Last Week on Treatment, Response Values) [ Time Frame: Baseline and 4 weeks ]
  MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. Weekly means obtained during the last week of each period of randomised treatment will be compared (measured by patients at home using the AM2+ device).
• Mean Number of Puffs of Rescue Medication During Daytime (Last Week on Treatment, Response Values) [ Time Frame: Baseline and 4 weeks ]
  MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. Weekly means obtained during the last week of each period of randomised treatment will be compared (measured by patients at home using the AM2+ device).
• Mean Number of Puffs of Rescue Medication During Nighttime (Last Week on Treatment, Response Values) [ Time Frame: Baseline and 4 weeks ]
  MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. Weekly means obtained during the last week of each period of randomised treatment will be compared (measured by patients at home using the AM2+ device).
• Mean Number of Night Awakenings During the Last Week on Treatment (Score, Response Values) [ Time Frame: Baseline and 4 weeks ]
  MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. Weekly means obtained during the last week of each period of randomised treatment will be compared (measured by patients at home using the AM2+ device).
• FEV1 Area Under the Curve Within 24 Hours (h) Response (FEV1 AUC0-12h, FEV1 AUC12-24h, FEV1 AUC0-24h) [ Time Frame: 10 minutes (min) before drug administration and 30 min, 1h, 2h, 3h, 4h, 11h 50min, 12h 30min, 13h, 14h, 15h, 16h, 18h, 20h, 22h, 23h, 23h 50min after drug administration ]
  MMRM results. Response was defined as change from baseline at the end of of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. FEV1 AUC0-12, FEV1 AUC12-24 and FEV1 AUC0-24 were calculated using the trapezoidal rule divided by the observation time (12h resp. 24h) to report in litres.
• FVC Area Under the Curve Within 24 Hours (h) Response (FVC AUC0-12h, FVC AUC12-24h, FVC AUC0-24h) [ Time Frame: 10 minutes (min) before drug administration and 30 min, 1h, 2h, 3h, 4h, 11h 50min, 12h 30min, 13h, 14h, 15h, 16h, 18h, 20h, 22h, 23h, 23h 50min after drug administration ]
  MMRM results. Response was defined as change from baseline at the end of of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. FVC AUC0-12, FVC AUC12-24 and FVC AUC0-24 were calculated using the trapezoidal rule divided by the observation time (12h resp. 24h) to report in litres.

Original Secondary Outcome Measures (submitted: November 2, 2010)

• trough FVC [ Time Frame: 4 weeks ]
• FEV1 (AUC0-3h) [ Time Frame: 4 weeks ]
• FVC (AUC0-3h) [ Time Frame: 4 weeks ]
• home assessment: PEF variability [ Time Frame: 4 weeks ]
• home assessment: use of pro re nata [p.r.n., if required] rescue medication [ Time Frame: 16 weeks ]
• home assessment: night time awakenings [ Time Frame: 16 weeks ]
• Asthma Control Questionnaire (ACQ) [ Time Frame: 4 weeks ]
• home assessment: FEV1 a.m./p.m. [last weekly mean of treatment period] [ Time Frame: last weekly mean of treatment period ]
• subset of patients: FEV1 (AUC0-24h) at visit 3 [ Time Frame: 4 weeks ]
• subset of patients: FVC (AUC0-12h) at visit 3 [ Time Frame: 4 weeks ]
• subset of patients: FVC (AUC12-24h) at visit 3 [ Time Frame: 4 weeks ]
• subset of patients: FVC (AUC0-24h) at visit 3 [ Time Frame: 4 weeks ]
• individual in-clinic forced vital capacity (FVC) measurements [ Time Frame: 4 weeks ]
• individual in-clinic peak expiratory flow (PEF) measurements [ Time Frame: 4 weeks ]
• Adverse events [ Time Frame: 19 weeks ]
• Vital signs: pulse rate and blood pressure [seated] recorded in conjunction with spirometry until 3 hours post-dose [ Time Frame: 4 weeks ]
• Pharmakokinetic evaluation: maximum concentration of tiotropium in plasma at visit 2 [ Time Frame: day 1 ]
• time from dosing to maximum tiotropium plasma concentration at visit 2 [ Time Frame: day 1 ]
• area under the concentration-time curve of tiotropium in plasma over the time interval from 0 to the last quantifiable data point within the first dosing interval at visit 2 [ Time Frame: day 1 ]
• area under the concentration-time curve of tiotropium in plasma over the time interval t1 to t2 at visit 2 [ Time Frame: day 1 ]
• area under the concentration-time curve of tiotropium in plasma over the time interval from 0 extrapolated to infinity at visit 2
• the percentage of the area under the concentration-time curve of tiotropium in plasma over the time interval from 0 extrapolated to infinity that is obtained by extrapolation at visit 2 [ Time Frame: day 1 ]
• terminal rate constant of tiotropium in plasma at visit 2 [ Time Frame: day 1 ]
• terminal half-life of tiotropium in plasma at visit 2 [ Time Frame: day 1 ]
• mean residence time of tiotropium in the body after inhalation at visit 2 [ Time Frame: day 1 ]
• apparent clearance of tiotropium in the plasma after extravascular administration at visit 2 [ Time Frame: day 1 ]
• apparent volume of distribution of tiotropium during the terminal phase following an extravascular dose at visit 2 [ Time Frame: day 1 ]
• renal clearance of tiotropium in plasma from the time point t1 to time point t2 at visit 2 [ Time Frame: day 1 ]
• amount of tiotropium that is eliminated unchanged in urine from the time point t1 to time point t2 at visit 2 [ Time Frame: day 1 ]
• fraction of tiotropium dose excreted in urine from time point t1 to t2 at visit 2 [ Time Frame: day 1 ]
• area under the concentration time curve of tiotropium in plasma over the time interval t1 to t2 at steady state at visits 3, 4, 5, and 6 (weeks 4, 8, 12 and 16) - tiotropium steady state will be assumed [ Time Frame: 4 weeks ]
• area under the plasma concentration-time curve at steady state over a uniform dosing interval t at steady state at visits 3, 4, 5, and 6 (weeks 4, 8, 12 and 16) - tiotropium steady state will be assumed [ Time Frame: 4 weeks ]
• maximum measured concentration of tiotropium in plasma at steady state at visits 3, 4, 5, and 6 (weeks 4, 8, 12 and 16) - tiotropium steady state will be assumed [ Time Frame: 4 weeks ]
• time from dosing to the maximum concentration of tiotropium in plasma at steady state at visits 3, 4, 5, and 6 (weeks 4, 8, 12 and 16) - tiotropium steady state will be assumed [ Time Frame: 4 weeks ]
• terminal rate constant in plasma at steady state at visits 3, 4, 5, and 6 (weeks 4, 8, 12 and 16) - tiotropium steady state will be assumed [ Time Frame: 4 weeks ]
• terminal half-life of tiotropium in plasma at steady state at visits 3, 4, 5, and 6 (weeks 4, 8, 12 and 16) - tiotropium steady state will be assumed [ Time Frame: 4 weeks ]
• mean residence time of tiotropium in the body after inhalational administration to steady state at visits 3, 4, 5, and 6 (weeks 4, 8, 12 and 16) - tiotropium steady state will be assumed [ Time Frame: 4 weeks ]
• apparent clearance of tiotropium from plasma after extravascular administration to steady state at visits 3, 4, 5, and 6 (weeks 4, 8, 12 and 16) - tiotropium steady state will be assumed [ Time Frame: 4 weeks ]
• apparent volume of distribution of tiotropium during the terminal phase following an extravascular dose at visits 3, 4, 5, and 6 (weeks 4, 8, 12 and 16) - tiotropium steady state will be assumed [ Time Frame: 4 weeks ]
• amount of tiotropium that is eliminated in urine from the time point t1 to time point t2 at visits 3, 4, 5, and 6 (weeks 4, 8, 12 and 16) - tiotropium steady state will be assumed [ Time Frame: 4 weeks ]
• fraction of tiotropium eliminated in urine from time point t1 to time point t2 at visits 3, 4, 5, and 6 (weeks 4, 8, 12 and 16) - tiotropium steady state will be assumed [ Time Frame: 4 weeks ]
• renal clearance of tiotropium from the time point t1 until the time point t2 at visits 3, 4, 5, and 6 (weeks 4, 8, 12 and 16) - tiotropium steady state will be assumed [ Time Frame: 4 weeks ]
• predose concentration of tiotropium in plasma at steady state at visits 3, 4, 5, and 6 (weeks 4, 8, 12 and 16) - tiotropium steady state will be assumed [ Time Frame: 4 weeks ]
• minimum concentration of tiotropium in plasma at steady state at visits 3, 4, 5, and 6 (weeks 4, 8, 12 and 16) - tiotropium steady state will be assumed [ Time Frame: 4 weeks ]
• Forced Vital Capacity [FVC] Peak0-3 [ Time Frame: 4 weeks ]
• Trough Forced Expiratory Volume in one second [trough FEV1] [ Time Frame: 4 weeks ]
• individual in-clinic FEV1 measurements [ Time Frame: 4 weeks ]
• home assessment: peak expiratory flow [PEF] ante meridiem/post meridiem [a.m./p.m.] [last weekly mean of treatment period] [ Time Frame: 4 weeks ]
• subset of patients: FEV1 area under the curve 0-12hrs [FEV1 (AUC0-12h)] at visit 3 [ Time Frame: 4 weeks ]
• subset of patients: FEV1 (AUC12-24h) at visit 3 [ Time Frame: 4 weeks ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Randomised, Double- Blind, Cross-over Efficacy and Safety Comparison of Three Different Doses of Tiotropium Administered Once Daily Versus Placebo in Patients With Moderate Persistent Asthma.
• Official Title: A Phase II Randomised, Double-blind, Placebo Controlled, Cross-over Efficacy and Safety Comparison of Three Doses of Tiotropium Inhalation Solution Delivered Via Respimat Inhaler (1.25, 2.5 and 5.0 Mcg Once Daily) Versus Placebo in Patients With Moderate Persistent Asthma.

Brief Summary

Rationale for the current trial is to evaluate the efficacy and safety of three doses (1.25 µg, 2.5 µg and 5.0 µg ex mouthpiece) of tiotropium inhalation solution in patients with moderate persistent asthma who are still symptomatic despite regular maintenance therapy with inhaled corticosteroids (ICS).

The data collected in the present trial will provide useful information to health care providers and patients regarding the efficacy and safety of a once daily inhalation of three different doses of tiotropium solution delivered by the Respimat® inhaler in addition to inhaled corticosteroids in the treatment of not fully controlled moderate asthma in comparison to placebo. The Pharmacokinetics (PK) of tiotropium is well established in COPD patients. However, there is currently no PK data available for the 3 doses of tiotropium being tested in this trial in patients with moderate persistent asthma. Tiotropium is a once daily drug. Hence, the rationale for blood and urine sampling for PK analysis over 24 hours in a subset of patients is to confirm the PK of the 3 doses in moderate asthma patients. Rationale for the 24-hour pulmonary function test sub-investigation is to demonstrate that a once daily dosing of tiotropium inhalation solution is effective and safe in the treatment of moderate persistent asthma.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double; Primary Purpose: Treatment
• Condition: Asthma

Intervention

• Drug: tiotropium bromide 2.5µg once daily
  Efficacy and safety comparison of 3 doses of inhaled tiotropium (1.25µg, 2.5µg and 5µg) versus placebo
• Drug: Tiotropium matching Placebo once daily
  Efficacy and safety comparison of 3 doses of inhaled tiotropium (1.25µg, 2.5µg and 5µg) versus placebo
• Drug: tiotropium bromide high dose once daily
  Efficacy and safety comparison of 3 doses of inhaled tiotropium (1.25µg, 2.5µg and 5µg) versus placebo
• Drug: tiotropium bromide 1.25µg once daily
  IMP

Study Arms

• Experimental: tiotropium low dose once daily
  once daily, delivered by the Respimat® inhaler
  Intervention: Drug: tiotropium bromide 1.25µg once daily
• Experimental: tiotropium medium dose once daily
  once daily, delivered by the Respimat® inhaler
  Intervention: Drug: tiotropium bromide 2.5µg once daily
• Experimental: tiotropium high dose once daily
  once daily, delivered by the Respimat® inhaler
  Intervention: Drug: tiotropium bromide high dose once daily
• Placebo Comparator: Placebo once daily
  once daily, delivered by the Respimat® inhaler
  Intervention: Drug: Tiotropium matching Placebo once daily

• Publications *: Beeh KM, Moroni-Zentgraf P, Ablinger O, Hollaenderova Z, Unseld A, Engel M, Korn S. Tiotropium Respimat(R) in asthma: a double-blind, randomised, dose-ranging study in adult patients with moderate asthma. Respir Res. 2014 Jun 3;15(1):61. doi: 10.1186/1465-9921-15-61.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 28, 2011): 149
• Original Estimated Enrollment (submitted: November 2, 2010): 120
• Study Completion Date: Not Provided
• Actual Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion criteria:

1. All patients must sign and date an Informed Consent Form consistent with the Harmonised Tripartite Guideline for Good Clinical Practice (ICH-GCP) and local legislation prior to participation in the trial (i.e. prior to any trial procedures, including any pre-trial washout of medications and medication restrictions for pulmonary function test at Visit 1).
2. Male or female patients aged between 18 and 75 years (at date of informed consent).
3. All patients must have at least a 3 month history of asthma at the time of enrolment into the trial. The diagnosis should be confirmed at Visit 1 by fulfilling inclusion criterion no. 5.
4. The initial diagnosis of asthma must have been made before the patient's age of 40.
5. The diagnosis of asthma has to be confirmed at Visit 1 with a bronchodilator reversibility (15 to 30 minutes after 4 puffs of 100 µg salbutamol) resulting in a Forced Expiratory Volume in one second (FEV1) increase of = 12% and = 200mL.
6. All patients must have been on maintenance treatment with a medium, stable dose of inhaled corticosteroids (alone or in a fixed combination with a long acting or short acting beta agonist [LABA or SABA]) for at least 4 weeks prior to Visit 1.
7. All patients must be symptomatic at Visit 1 (screening) and prior to randomisation at Visit 2 as defined by an Asthma Control Questionnaire (ACQ) mean score of = 1.5.
8. All patients must have a pre-bronchodilator FEV1 = 60% and = 90% of predicted normal at Visit 1. Predicted normal values will be calculated according to the European Community for Steel and Coal (ECSC).
9. Variation of absolute FEV1 values of Visit 1 (pre-bronchodilator) as compared to Visit 2 (pre-dose) must be within ± 30%.
10. Patients must be never-smokers or ex-smokers who stopped smoking at least one year prior to enrolment (Visit 0) and who have a smoking history of less than 10 pack years.
11. Patients must be able to use the Respimat® inhaler correctly.
12. 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:

1. Patients with a significant disease other than asthma.
2. Patients with a clinically relevant abnormal screening (Visit 1) haematology or blood chemistry if the abnormality defines a significant disease as defined in exclusion criterion 1.
3. Patients with a recent history (i.e. six months or less) of myocardial infarction.
4. Patients who have been hospitalised for cardiac failure during the past year.
5. Patients with any unstable or life-threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year.
6. Patients with lung diseases other than asthma.
7. Patients with known active tuberculosis.
8. Patients with malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years.
9. Patients who have undergone thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reasons should be evaluated as per exclusion criterion no. 1.
10. Patients with known moderate to severe renal impairment.
11. Patients with known narrow angle glaucoma or any other disease where anticholinergic treatment is contraindicated.
12. Patients with significant symptomatic prostatic hyperplasia or bladder-neck obstruction. Patients whose symptoms are controlled on treatment may be included.
13. Patients with significant alcohol or drug abuse within the past two years (to the discretion of the investigator).
14. Patients who are currently in a pulmonary rehabilitation program or have completed pulmonary rehabilitation program in the 6 weeks prior to Visit 1 (screening) or who will start a rehabilitation program during the study.
15. Patients with known hypersensitivity to anticholinergic drugs, Benzalkonium chloride (BAC), Ethylenediaminetetraacetate (EDTA) or any other components of the study medication delivery system (Respimat®/ tiotropium inhalation solution).
16. Pregnant or nursing woman.
17. Women of childbearing potential not using a highly effective method of birth control.
18. Patients who have taken an investigational drug within four weeks prior to Visit 1.
19. Patients who have been treated with beta-blocker medication within four weeks prior to Visit 1 and/or during the screening period (period between Visit 1 and Visit 2). Topical cardio-selective beta-blocker eye medications for non-arrow angle glaucoma are allowed.
20. Patients who have been treated with the long-acting anticholinergic tiotropium (Spiriva®) within four weeks prior to Visit 1 and/or during the screening period (period between Visit 1 and Visit 2).
21. Patients who have been treated with oral or patch beta-adrenergics within four weeks prior to Visit 1 and/or during the Screening period (period between Visit 1 and Visit 2)
22. Patients who have been treated with oral corticosteroids within four weeks prior to Visit 1 and/or during the screening period.
23. Patients who have been treated with anti-Immunoglobuline E (anti-IgE) antibodies, e.g. omalizumab, within 6 months prior to Visit 1 and/or during the screening period (period between Visit 1 and Visit 2).
24. Patients who have been treated with cromone within two weeks prior to Visit 1 and/or during the screening period (period between Visit 1 and Visit 2).
25. Patients who have been treated with methylxanthines or phosphodiesterase 4 inhibitors within two weeks prior to Visit 1 and/or during the screening period (period between Visit 1 and Visit 2).
26. Patients who have been treated with other non-approved and according to international guidelines not recommended experimental drugs for routine asthma therapy (e.g. Tumor Necrosis Factor (TNF)-alpha blockers, methotrexate, cyclosporin) within four weeks prior to Visit 1 and/or during the screening period (period between Visit 1 and Visit 2).
27. Patient with any asthma exacerbation or respiratory tract infection in the 4 weeks prior to visit 1 and/or during the screening period.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Austria, Germany, Ukraine

Administrative Information

• NCT Number: NCT01233284
• Other Study ID Numbers: 205.380; 2010-018471-26 ( EudraCT Number: EudraCT )
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Boehringer Ingelheim
• Original Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
• Current Study Sponsor: Boehringer Ingelheim
• Original Study Sponsor: Same as current
• Collaborators: Pfizer

Investigators

• Study Chair: Boehringer Ingelheim; Boehringer Ingelheim

• PRS Account: Boehringer Ingelheim
• Verification Date: September 2013