Evaluation of Tiotropium 2.5 and 5 mcg Once Daily Delivered Via the Respimat® Inhaler Compared to Placebo and Salmeterol HydroFluoroAlkane (HFA) Metered Dose Inhaler (MDI) (50 mcg Twice Daily) in Patient With Moderate Persistent Asthma I

NCT01172808

Last updated date
Study Location
205.418.01020 Boehringer Ingelheim Investigational Site
Huntington Beach, California, , United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Asthma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. All patients must sign and date an Informed Consent Form consistent with International Conference on Harmonisation - Good Clinical Practice (ICH-GCP) guidelines 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 at least 18 years but not more than 75 years.

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 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 minutes after 400 mcg salbutamol (albuterol)) resulting in a Forced Expiratory Volume in one second (FEV1) increase of at least 12% and at least 200mL.

6. All patients must have been on maintenance treatment with a medium, stable dose of inhaled corticosteroids for at least for 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 at least 1.5.

8. All patients must have a pre-bronchodilator FEV1 at least 60% and less than or equal to 90% of predicted normal at Visit 1.

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 and metered dose 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.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


1. Patients with a significant disease other than asthma. A significant disease is
defined as a disease which, in the opinion of the investigator, may (i) put the
patient at risk because of participation in the trial, or (ii) influence the results
of the trial, or (iii) cause concern regarding the patient's ability to participate in
the trial.


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 (e.g. Chronic Obstructive Pulmonary
Disease (COPD)).


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. Patients with treated basal cell
carcinoma are allowed.


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 significant alcohol or drug abuse within the past two years.


11. Patients who are currently in a pulmonary rehabilitation program or have completed a
pulmonary rehabilitation program in the 6 weeks prior to Visit 1 (screening).


12. Patients with known hypersensitivity to anticholinergic drugs, benzalkonium chloride
(BAC), ethylenediamineteraacetic acid (EDTA), salmeterol xinafoate or any other
components of the study medication delivery systems.


13. Pregnant or nursing woman.


14. Women of childbearing potential not using a highly effective method of birth control.


15. Patients who have taken an investigational drug within four weeks prior to Visit 1.


16. Patients who have been treated with beta-blocker medication within four weeks prior to
Visit 1 and/or during the screening period. Topical cardio-selective beta-blocker eye
medications for non-narrow angle glaucoma are allowed.


17. 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.


18. Patients who have been treated with oral or patch beta-adrenergics within four weeks
prior to Visit 1 and/or during the Screening period.


19. Patients who have been treated with oral corticosteroids within four weeks prior to
Visit 1 and/or during the screening period.


20. Patients who have been treated with anti-IgE antibodies, e.g. omalizumab (Xolair®),
within 6 months prior to Visit 1 and/or during the screening period.


21. Patients who have been treated with cromone within two weeks prior to Visit 1 and/or
during the screening period.


22. Patients who have been treated with methylxanthines or phosphodiesterase 4 inhibitors
within two weeks prior to Visit 1 and/or during the screening period.


23. Patients who have been treated with other 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.


24. Patients with any asthma exacerbation or any respiratory tract infection iin the four
weeks prior to Visit 1 and/or during the screening period.


25. Patients who have previously been randomised in this trial or in the respective twin
trial (205.419) or are currently participating in another trial.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Evaluation of Tiotropium 2.5 and 5 mcg Once Daily Delivered Via the Respimat® Inhaler Compared to Placebo and Salmeterol HydroFluoroAlkane (HFA) Metered Dose Inhaler (MDI) (50 mcg Twice Daily) in Patient With Moderate Persistent Asthma I
Official Title  ICMJE A Phase III Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate Efficacy and Safety of Tiotropium Inhalation Solution Delivered Via Respimat® Inhaler (2.5 and 5 µg Once Daily) Compared With Placebo and Salmeterol HFA MDI (50 µg Twice Daily) Over 24 Weeks in Moderate Persistent Asthma
Brief Summary The aim of this trial is to evaluate the efficacy and safety of 2.5 and 5 mcg tiotropium over a 24-week treatment period as compared to placebo and salmeterol (50 mcg twice daily). Tiotropium inhalation solution delivered by the Respimat® inhaler will be examined on top of maintenance treatment with inhaled corticosteroid controller medication in patients with moderate persistent asthma. Efficacy and safety will be assessed by measuring effects on lung function, effects on asthma exacerbations, effects on quality of life, effects on asthma control, effects on health care resource utilisation, and number of adverse events.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • Drug: Placebo
    Placebo that represents comparator
  • Drug: tiotropium Respimat® low dose
    IMP
  • Drug: tiotropium Respimat® high dose
    IMP
  • Drug: 50 mcg salmeterol HFA MDI
    Active comparator
  • Drug: Placebo
    Placebo that represents BI drug
Study Arms  ICMJE
  • Experimental: tiotropium low dose
    Once daily, delivered with Respimat® inhaler (+ inhalation of placebo HFA MDI twice daily)
    Interventions:
    • Drug: Placebo
    • Drug: tiotropium Respimat® low dose
  • Experimental: tiotropium high dose
    Once daily, delivered with Respimat® inhaler (+ inhalation of placebo HFA MDI twice daily)
    Interventions:
    • Drug: Placebo
    • Drug: tiotropium Respimat® high dose
  • Active Comparator: 50 mcg salmeterol
    Twice daily, delivered with HFA MDI (+ inhalation of placebo Respimat® inhaler once daily)
    Interventions:
    • Drug: 50 mcg salmeterol HFA MDI
    • Drug: Placebo
  • Placebo Comparator: placebo
    Once daily, delivered with Respimat® inhaler + twice daily delivered with HFA MDI
    Interventions:
    • Drug: Placebo
    • Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 27, 2012)
1071
Original Estimated Enrollment  ICMJE
 (submitted: July 29, 2010)
1000
Actual Study Completion Date  ICMJE November 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  1. All patients must sign and date an Informed Consent Form consistent with International Conference on Harmonisation - Good Clinical Practice (ICH-GCP) guidelines 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 at least 18 years but not more than 75 years.
  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 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 minutes after 400 mcg salbutamol (albuterol)) resulting in a Forced Expiratory Volume in one second (FEV1) increase of at least 12% and at least 200mL.
  6. All patients must have been on maintenance treatment with a medium, stable dose of inhaled corticosteroids for at least for 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 at least 1.5.
  8. All patients must have a pre-bronchodilator FEV1 at least 60% and less than or equal to 90% of predicted normal at Visit 1.
  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 and metered dose 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.

Exclusion criteria:

  1. Patients with a significant disease other than asthma. A significant disease is defined as a disease which, in the opinion of the investigator, may (i) put the patient at risk because of participation in the trial, or (ii) influence the results of the trial, or (iii) cause concern regarding the patient's ability to participate in the trial.
  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 (e.g. Chronic Obstructive Pulmonary Disease (COPD)).
  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. Patients with treated basal cell carcinoma are allowed.
  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 significant alcohol or drug abuse within the past two years.
  11. Patients who are currently in a pulmonary rehabilitation program or have completed a pulmonary rehabilitation program in the 6 weeks prior to Visit 1 (screening).
  12. Patients with known hypersensitivity to anticholinergic drugs, benzalkonium chloride (BAC), ethylenediamineteraacetic acid (EDTA), salmeterol xinafoate or any other components of the study medication delivery systems.
  13. Pregnant or nursing woman.
  14. Women of childbearing potential not using a highly effective method of birth control.
  15. Patients who have taken an investigational drug within four weeks prior to Visit 1.
  16. Patients who have been treated with beta-blocker medication within four weeks prior to Visit 1 and/or during the screening period. Topical cardio-selective beta-blocker eye medications for non-narrow angle glaucoma are allowed.
  17. 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.
  18. Patients who have been treated with oral or patch beta-adrenergics within four weeks prior to Visit 1 and/or during the Screening period.
  19. Patients who have been treated with oral corticosteroids within four weeks prior to Visit 1 and/or during the screening period.
  20. Patients who have been treated with anti-IgE antibodies, e.g. omalizumab (Xolair®), within 6 months prior to Visit 1 and/or during the screening period.
  21. Patients who have been treated with cromone within two weeks prior to Visit 1 and/or during the screening period.
  22. Patients who have been treated with methylxanthines or phosphodiesterase 4 inhibitors within two weeks prior to Visit 1 and/or during the screening period.
  23. Patients who have been treated with other 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.
  24. Patients with any asthma exacerbation or any respiratory tract infection iin the four weeks prior to Visit 1 and/or during the screening period.
  25. Patients who have previously been randomised in this trial or in the respective twin trial (205.419) or are currently participating in another trial.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil,   China,   Guatemala,   India,   Japan,   Latvia,   Mexico,   Peru,   Poland,   Russian Federation,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01172808
Other Study ID Numbers  ICMJE 205.418
2009-018004-18 ( EudraCT Number: EudraCT )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Chair:Boehringer IngelheimBoehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP