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

NCT01634152

Last updated date
Study Location
205.446.01014 Boehringer Ingelheim Investigational Site
Rolling Hills Estates, 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
6-11 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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 either at stable high dose in combination with another controller medication, OR at stable medium dose in combination with two other controller medications, for at least 4 weeks before Visit 1.

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


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 hospitalised 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 girls with a positive
urine pregnancy test at Visit 1.


11. Postmenarchal girls of child-bearing potential not using a highly effective method of
birth control.


12. Patients who have been treated with systemic corticosteroids within four weeks prior
to Visit 1.


13. Patients who have been treated with systemic beta-adrenergics within four weeks prior
to Visit 1.


14. Patients who have been treated with oral beta-blocker medication within four weeks
prior to Visit 1 and/or during the screening period.


15. 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.


16. Patients who have been treated with short-acting theophylline preparations within two
weeks prior to Visit 1.


17. 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.


18. 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.


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


20. Patients with any acute asthma exacerbation or respiratory tract infection 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.


21. 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.


22. Patients who are unable to comply with medication restrictions prior to Visit 1 and/or
prior to Visit 2.


23. Patients with a known narrow-angle glaucoma, or any other disease where
anticholinergic treatment is contraindicated.


24. 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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of 2 Doses of Tiotropium Respimat® Compared to Placebo in Children With Severe Persistent Asthma
Official Title  ICMJE 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 12 Weeks as add-on Controller Therapy on Top of Usual Care in Children (6 to 11 Years Old) With Severe Persistent Asthma
Brief Summary The overall purpose of the trial is 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 12 weeks, compared to placebo, as add-on controller therapy on top of usual care in children (6 to 11 years old) with severe persistent asthma.
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
    2 actuations once daily in the evening
  • Drug: Tiotropium low dose mcg
    2 actuations once daily in the evening
  • Drug: Tiotropium high dose
    2 actuations once daily in the evening
Study Arms  ICMJE
  • Placebo Comparator: Placebo QD
    Intervention: Drug: Placebo
  • Experimental: Tiotropium low dose QD
    Intervention: Drug: Tiotropium low dose mcg
  • Experimental: Tiotropium medium dose QD
    Intervention: Drug: Tiotropium high dose
Publications * Not Provided

*   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 2, 2015)
401
Original Estimated Enrollment  ICMJE
 (submitted: July 3, 2012)
375
Actual Study Completion Date  ICMJE May 2015
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 either at stable high dose in combination with another controller medication, OR at stable medium dose in combination with two other controller medications, for at least 4 weeks before Visit 1.
  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 hospitalised 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 girls with a positive urine pregnancy test at Visit 1.
  11. Postmenarchal girls of child-bearing potential not using a highly effective method of birth control.
  12. Patients who have been treated with systemic corticosteroids within four weeks prior to Visit 1.
  13. Patients who have been treated with systemic beta-adrenergics within four weeks prior to Visit 1.
  14. Patients who have been treated with oral beta-blocker medication within four weeks prior to Visit 1 and/or during the screening period.
  15. 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.
  16. Patients who have been treated with short-acting theophylline preparations within two weeks prior to Visit 1.
  17. 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.
  18. 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.
  19. Patients who have previously been randomised in this trial or are currently participating in another trial.
  20. Patients with any acute asthma exacerbation or respiratory tract infection 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.
  21. 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.
  22. Patients who are unable to comply with medication restrictions prior to Visit 1 and/or prior to Visit 2.
  23. Patients with a known narrow-angle glaucoma, or any other disease where anticholinergic treatment is contraindicated.
  24. 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 6 Years to 11 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Belgium,   Brazil,   Canada,   Czech Republic,   Germany,   Guatemala,   Hungary,   Latvia,   Lithuania,   Poland,   Romania,   Russian Federation,   Slovakia,   Ukraine,   United States
Removed Location Countries Bulgaria,   Norway
 
Administrative Information
NCT Number  ICMJE NCT01634152
Other Study ID Numbers  ICMJE 205.446
2011-001777-43 ( 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 December 2015

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