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.

NCT01233284

Last updated date
Study Location
205.380.43002 Boehringer Ingelheim Investigational Site
Hallein, , , Austria
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 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
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.


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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • 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  ICMJE
  • 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® in asthma: a double-blind, randomised, dose-ranging study in adult patients with moderate asthma. Respir Res. 2014 Jun 3;15:61. doi: 10.1186/1465-9921-15-61.

*   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 28, 2011)
149
Original Estimated Enrollment  ICMJE
 (submitted: November 2, 2010)
120
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date January 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 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  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 Austria,   Germany,   Ukraine
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01233284
Other Study ID Numbers  ICMJE 205.380
2010-018471-26 ( 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 September 2013

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