A Randomised, Double- Blind, Placebo Controlled, Cross-over Efficacy and Safety Comparison of Tiotropium 5 µg Once Daily and Tiotropium 2.5 µg Twice Daily for Four Weeks in Patients With Moderate Persistent Asthma

NCT01152450

Last updated date
Study Location
205.420.43002 Boehringer Ingelheim Investigational Site
Linz, , , 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 International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use 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 months history of asthma at the time of enrolment into the trial. The diagnosis of asthma has to be confirmed at Visit 1 with a bronchodilator reversibility resulting in a Forced Expiratory Volume in 1 Second (FEV1) increase of equal above 12% and equal above 200mL.

4. The initial diagnosis of asthma must have been made before the patient's age of 40.

5. All patients must have a diagnosis of moderate persistent asthma and must be symptomatic despite their current maintenance treatment with medium doses of inhaled corticosteroids.

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 Betaadrenergic (LABA) or Short Acting Betaadrenergic (SABA)) for at least 4 weeks prior to Visit 1.

7. All patients must be symptomatic at Visit 1 (screening) and Visit 2 as defined by an Asthma Control Questionnaire (ACQ) Score

8. All patients must have a pre-bronchodilator FEV1 above equal 60% predicted and below equal 90% of predicted normal at Visit 1. Predicted normal values will be calculated according to the European Coal and Steel Community Guidelines (ECSC).

9. All patients must have an increase in FEV1 of equal above 12% and equal above 200 mL 15 minutes after 400 µg salbutamol at Visit 1.

10. Variation of absolute FEV1 values of Visit 1 (pre-bronchodilator) as compared to Visit 2 (pre-dose) must be within ± 30% .

11. Patients must be never-smokers or ex-smokers who stopped smoking at least one year prior to enrolment and who have a smoking history of less than 10 pack years.

12. Patients must be able to use the Respimat® inhaler correctly.

13. Patients must be able to perform all trial related procedures including technically acceptable pulmonary function tests and use of the e-Diary/peak flow meter.

14. Patients taking a chronic pulmonary medication allowed by the study protocol must be willing to continue this therapy for the entire duration of the study (exception: times of acute disease deterioration).

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 hematology or blood chemistry
if the abnormality defines a significant disease as defined in exclusion criterion no.
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 Lung 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.


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 V 1.


12. Patients with known hypersensitivity to anticholinergic drugs, Benzalconiumchloride
(BAC), Ethylenediaminetetraacetate (EDTA) or any other components of the study
medication delivery systems.


13. Pregnant or nursing women.


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


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


16. Patients who have been treated with the long-acting anticholinergic tiotropium
(Spiriva®) within four weeks prior to Visit 1 or during the screening period.


17. Patients who have been treated with oral beta-adrenergics within four weeks prior to
Visit 1 or during the screening period.


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


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


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


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


23. Patients who have been treated with other non-approved and according to international
guidelines not recommended "experimental" drugs for routine asthma therapy (e.g. TNFalpha
blockers, methotrexate, cyclosporin) within four weeks prior to Visit 1 or during the
screening period.


24. Patients with any asthma exacerbation or any respiratory tract infection in the four
weeks prior to Visit 1 or during the screening period. Visit 1 and/or Visit 2 should be
postponed in case of an asthma exacerbation or respiratory tract infection.


25. Patients who have previously been randomised in this trial or are currently
participating in another trial.


26.Patients who have been treated with depot corticosteroids within six months prior to
Visit 1 or during the screening period.


27.Patients who have been treated with leukotriene modifiers within two weeks prior to
Visit 1 or during the screening period.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Randomised, Double- Blind, Placebo Controlled, Cross-over Efficacy and Safety Comparison of Tiotropium 5 µg Once Daily and Tiotropium 2.5 µg Twice Daily for Four Weeks in Patients With Moderate Persistent Asthma
Official Title  ICMJE A Phase II, Randomised, Double- Blind, Placebo Controlled, Cross-over Efficacy and Safety Comparison of Tiotropium 5 µg Administered Once Daily (in the Evening) and Tiotropium 2.5 µg Administered Twice Daily Delivered by the Respimat® Inhaler for Four Weeks Versus Placebo in Patients With Moderate Persistent Asthma
Brief Summary

Rationale for the current trial is to demonstrate 24 hour bronchodilator efficacy and safety of tiotropium 5 µg administered once daily (in the evening) which is regarded beneficial for the compliance and convenience of the patient in comparison to placebo. Further the rationale is to evaluate efficacy and safety of tiotropium 2.5 µg administered twice daily delivered by the Respimat® inhaler in comparison to placebo and tiotropium 5 µg administered once daily (in the evening) delivered by the Respimat® inhaler in patients with moderate persistent asthma.

Rationale for the pharmacokinetic subinvestigation is to evaluate the 24 hours exposure to tiotropium in patients with moderate persistent asthma when administered 5 µg tiotropium once daily (in the evening) or 2.5 µg tiotropium twice daily.

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 2.5 µg b.i.d
    2.5 µg (two actuations of 1.25 µg) delivered via Respimat® inhaler
  • Drug: Placebo
    N/A (two actuations of placebo) delivered via Respimat® inhaler
  • Drug: Tiotropium 5 µg q.d.
    5 µg (two actuations of 2.5 µg) delivered via Respimat® inhaler
Study Arms  ICMJE
  • Experimental: Tiotropium daily dose q.d.
    two actuations delivered via Respimat® inhaler
    Intervention: Drug: Tiotropium 5 µg q.d.
  • Experimental: Tiotropium half daily dose b.i.d.
    two actuations delivered via Respimat® inhaler
    Intervention: Drug: Tiotropium 2.5 µg b.i.d
  • Placebo Comparator: Placebo
    N/A (two actuations of placebo) delivered via Respimat® inhaler
    Intervention: Drug: Placebo
Publications * Timmer W, Moroni-Zentgraf P, Cornelissen P, Unseld A, Pizzichini E, Buhl R. Once-daily tiotropium Respimat(®) 5 ?g is an efficacious 24-h bronchodilator in adults with symptomatic asthma. Respir Med. 2015 Mar;109(3):329-38. doi: 10.1016/j.rmed.2014.12.005. Epub 2014 Dec 27.

*   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: September 23, 2011)
94
Original Estimated Enrollment  ICMJE
 (submitted: June 28, 2010)
90
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date August 2011   (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 of Technical Requirements for Registration of Pharmaceuticals for Human Use 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 months history of asthma at the time of enrolment into the trial. The diagnosis of asthma has to be confirmed at Visit 1 with a bronchodilator reversibility resulting in a Forced Expiratory Volume in 1 Second (FEV1) increase of equal above 12% and equal above 200mL.
  4. The initial diagnosis of asthma must have been made before the patient's age of 40.
  5. All patients must have a diagnosis of moderate persistent asthma and must be symptomatic despite their current maintenance treatment with medium doses of inhaled corticosteroids.
  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 Betaadrenergic (LABA) or Short Acting Betaadrenergic (SABA)) for at least 4 weeks prior to Visit 1.
  7. All patients must be symptomatic at Visit 1 (screening) and Visit 2 as defined by an Asthma Control Questionnaire (ACQ) Score
  8. All patients must have a pre-bronchodilator FEV1 above equal 60% predicted and below equal 90% of predicted normal at Visit 1. Predicted normal values will be calculated according to the European Coal and Steel Community Guidelines (ECSC).
  9. All patients must have an increase in FEV1 of equal above 12% and equal above 200 mL 15 minutes after 400 µg salbutamol at Visit 1.
  10. Variation of absolute FEV1 values of Visit 1 (pre-bronchodilator) as compared to Visit 2 (pre-dose) must be within ± 30% .
  11. Patients must be never-smokers or ex-smokers who stopped smoking at least one year prior to enrolment and who have a smoking history of less than 10 pack years.
  12. Patients must be able to use the Respimat® inhaler correctly.
  13. Patients must be able to perform all trial related procedures including technically acceptable pulmonary function tests and use of the e-Diary/peak flow meter.
  14. Patients taking a chronic pulmonary medication allowed by the study protocol must be willing to continue this therapy for the entire duration of the study (exception: times of acute disease deterioration).

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 hematology or blood chemistry if the abnormality defines a significant disease as defined in exclusion criterion no. 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 Lung 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.
  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 V 1.
  12. Patients with known hypersensitivity to anticholinergic drugs, Benzalconiumchloride (BAC), Ethylenediaminetetraacetate (EDTA) or any other components of the study medication delivery systems.
  13. Pregnant or nursing women.
  14. Women of childbearing potential not using a highly effective method of birth control.
  15. Patients who have been treated with beta-blocker medication within four weeks prior to Visit 1 or during the screening period. Topical cardio-selective beta-blocker eye medications for non-arrow angle glaucoma are allowed.
  16. Patients who have been treated with the long-acting anticholinergic tiotropium (Spiriva®) within four weeks prior to Visit 1 or during the screening period.
  17. Patients who have been treated with oral beta-adrenergics within four weeks prior to Visit 1 or during the screening period.
  18. Patients who have been treated with oral corticosteroids within four weeks prior to Visit 1 or during the screening period.
  19. Patients who have been treated with anti-IgE antibodies, e.g. omalizumab (Xolair®), within 6 months prior to Visit 1 or during the screening period.20. Patients who have been treated with cromolyn sodium or nedocromil sodium within two weeks prior to Visit 1 or during the screening period.

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

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

23. Patients who have been treated with other non-approved and according to international guidelines not recommended "experimental" drugs for routine asthma therapy (e.g. TNFalpha blockers, methotrexate, cyclosporin) within four weeks prior to Visit 1 or during the screening period.

24. Patients with any asthma exacerbation or any respiratory tract infection in the four weeks prior to Visit 1 or during the screening period. Visit 1 and/or Visit 2 should be postponed in case of an asthma exacerbation or respiratory tract infection.

25. Patients who have previously been randomised in this trial or are currently participating in another trial.

26.Patients who have been treated with depot corticosteroids within six months prior to Visit 1 or during the screening period.

27.Patients who have been treated with leukotriene modifiers within two weeks prior to Visit 1 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,   Czech Republic,   Estonia,   Germany,   Latvia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01152450
Other Study ID Numbers  ICMJE 205.420
2009-018006-21 ( 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 February 2013

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