Efficacy and Safety of 3 Doses of Tiotropium Compared to Placebo in Adolescents (12 to 17 Yrs) With Moderate Asthma

NCT01122680

Last updated date
Study Location
205.424.01002 Boehringer Ingelheim Investigational Site
Denver, Colorado, , 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
12-17 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. All patients and legally accepted caregiver(s) must sign and date an Informed Consent form consistent with Good Clinical Practice (GCP) guidelines of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and local legislation prior to participation in the trial.

2. Male or female patients between 12 and 17 years of age.

3. All patients must have at least a 3 months history of asthma and fulfill the diagnostic criteria of moderate persistent asthma, according to the current Global Initiative for Asthma (GINA) guidelines at the time of enrolment into the trial.

4. All patients must have been on maintenance treatment with inhaled corticosteroids at a stable medium dose for at least 4 weeks before Visit 1.

5. All patients must be symptomatic (partly controlled) at Visit 1 (screening) and prior to randomisation at Visit 2 as defined by an Asthma Control Questionnaire (ACQ) mean score of equal or above 1.5.

6. All patients must have a pre-bronchodilator FEV1 above 60% and less than or equal 90% of predicted normal at Visit 1. Variation of absolute FEV1 values of Visit 1 (pre-bronchodilator) as compared to Visit 2 (pre-dose) must be within ± 30%.

7. All patients must have an increase in FEV1 of equal or above 12% and 200 mL 15 min. after 400 mcg salbutamol (albuterol) at Visit 1. If patients in the lower age range (e.g., 12 to 14 year olds) exhibit a very small total lung volume, positive reversibility testing might be based solely on the relative (12%) post-bronchodilator response.

8. All patients should be never-smokers or ex-smokers who stopped smoking at least one year prior to enrolment.

9. Patients should be able to use the Respimat® inhaler correctly.

10. Patients must be able to perform all trial related procedures including technically acceptable spirometric manoeuvres, according to American Thoracic Society (ATS) standards and the use of the 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.


2. Patients with a history of congenital or acquired heart disease, and/or have been
hospitalised for cardiac syncope or failure during the past year.


3. Patients with any unstable or life-threatening cardiac arrhythmia or cardiac
arrhythmia requiring intervention (e. g. pacemaker implantation) or a change in drug
therapy within the past year.


4. Patients with malignancy for which the patient has undergone resection, radiation
therapy or chemotherapy within the last five years.


5. Patients with lung diseases other than asthma, e.g. cystic fibrosis (CF). In case of
ex-premature infants, a history of significant bronchopulmonary dysplasia (BPD) will
be regarded as exclusion criterion


6. Patients with significant alcohol or drug abuse within the past two years.


7. Patients with known hypersensitivity to anticholinergic drugs, benzalkonium chloride
(BAC), ethylenediaminetetraacetic acid (EDTA) or any other components of the
tiotropium inhalation solution.


8. Pregnant or nursing adolescent female patients, including female patients with a
positive Beta HCG (serum pregnancy) testing at screening (visit 1).


9. Sexually active female patients of child-bearing potential not using a highly
effective method of birth control.


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


11. Patients with renal impairment, as defined by a creatinine clearance less than 50
mL/min/1.73 m2 body surface area (BSA) as calculated by Schwartz Formula.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of 3 Doses of Tiotropium Compared to Placebo in Adolescents (12 to 17 Yrs) With Moderate Asthma
Official Title  ICMJE A Phase II Randomised, Double-blind, Placebo-controlled, Incomplete Crossover Trial With 4-week Treatment Periods to Evaluate Efficacy and Safety of Tiotropium Inhalation Solution (Doses of 1.25 µg, 2.5 µg and 5 µg) Delivered Via Respimat® Inhaler Once Daily in the Evening in Adolescents (12 to 17 Yrs Old) With Moderate Persistent Asthma
Brief Summary The primary objective of this trial is to evaluate the efficacy and safety of tiotropium 1.25 mcg (2 actuations of 0.625 mcg), tiotropium 2.5 mcg (2 actuations of 1.25 mcg) and tiotropium 5 mcg (2 actuations of 2.5 mcg) once daily in the evening delivered by the Respimat inhaler in adolescents (12 to 17 yrs) with moderate persistent asthma, compared to placebo and on top of maintenance therapy with an inhaled corticosteroid controller medication. It is a randomised, double-blind, placebo-controlled Phase II trial with incomplete cross-over design. Patients need to be still symptomatic, i. e. not fully controlled with their maintenance treatment.
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
    inhalation solution, dose of 1.25 mcg (2 puffs of 0.625 mcg)
  • Drug: tiotropium bromide
    inhalation solution, dose of 2.5 mcg (2 puffs of 1.25 mcg)
  • Drug: tiotropium bromide
    inhalation solution, dose of 5 mcg (2 puffs of 2.5 mcg)
  • Drug: Placebo
    placebo inhalation solution
Study Arms  ICMJE
  • Experimental: Treatment A
    patients inhale 2 puffs (dose of 1.25 mcg) once daily in the evening via Respimat inhaler
    Intervention: Drug: Tiotropium bromide
  • Experimental: Treatment C
    patients inhale 2 puffs (dose of 5 mcg) once daily in the evening via Respimat inhaler
    Intervention: Drug: tiotropium bromide
  • Placebo Comparator: Placebo
    patients inhale 2 puffs of placebo matching tiotropium once daily in the evening via Respimat inhaler
    Intervention: Drug: Placebo
  • Experimental: Treatment B
    patients inhale 2 puffs (dose of 2.5 mcg) once daily in the evening via Respimat inhaler
    Intervention: Drug: tiotropium bromide
Publications * Vogelberg C, Engel M, Moroni-Zentgraf P, Leonaviciute-Klimantaviciene M, Sigmund R, Downie J, Nething K, Vevere V, Vandewalker M. Tiotropium in asthmatic adolescents symptomatic despite inhaled corticosteroids: a randomised dose-ranging study. Respir Med. 2014 Sep;108(9):1268-76. doi: 10.1016/j.rmed.2014.06.011. Epub 2014 Jul 17.

*   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: May 4, 2011)
105
Original Estimated Enrollment  ICMJE
 (submitted: May 11, 2010)
92
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  1. All patients and legally accepted caregiver(s) must sign and date an Informed Consent form consistent with Good Clinical Practice (GCP) guidelines of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and local legislation prior to participation in the trial.
  2. Male or female patients between 12 and 17 years of age.
  3. All patients must have at least a 3 months history of asthma and fulfill the diagnostic criteria of moderate persistent asthma, according to the current Global Initiative for Asthma (GINA) guidelines at the time of enrolment into the trial.
  4. All patients must have been on maintenance treatment with inhaled corticosteroids at a stable medium dose for at least 4 weeks before Visit 1.
  5. All patients must be symptomatic (partly controlled) at Visit 1 (screening) and prior to randomisation at Visit 2 as defined by an Asthma Control Questionnaire (ACQ) mean score of equal or above 1.5.
  6. All patients must have a pre-bronchodilator FEV1 above 60% and less than or equal 90% of predicted normal at Visit 1. Variation of absolute FEV1 values of Visit 1 (pre-bronchodilator) as compared to Visit 2 (pre-dose) must be within ± 30%.
  7. All patients must have an increase in FEV1 of equal or above 12% and 200 mL 15 min. after 400 mcg salbutamol (albuterol) at Visit 1. If patients in the lower age range (e.g., 12 to 14 year olds) exhibit a very small total lung volume, positive reversibility testing might be based solely on the relative (12%) post-bronchodilator response.
  8. All patients should be never-smokers or ex-smokers who stopped smoking at least one year prior to enrolment.
  9. Patients should be able to use the Respimat® inhaler correctly.
  10. Patients must be able to perform all trial related procedures including technically acceptable spirometric manoeuvres, according to American Thoracic Society (ATS) standards and the use of the electronic diary/peak flow meter.

Exclusion criteria:

  1. Patients with a significant disease other than asthma.
  2. Patients with a history of congenital or acquired heart disease, and/or have been hospitalised for cardiac syncope or failure during the past year.
  3. Patients with any unstable or life-threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention (e. g. pacemaker implantation) or a change in drug therapy within the past year.
  4. Patients with malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years.
  5. Patients with lung diseases other than asthma, e.g. cystic fibrosis (CF). In case of ex-premature infants, a history of significant bronchopulmonary dysplasia (BPD) will be regarded as exclusion criterion
  6. Patients with significant alcohol or drug abuse within the past two years.
  7. Patients with known hypersensitivity to anticholinergic drugs, benzalkonium chloride (BAC), ethylenediaminetetraacetic acid (EDTA) or any other components of the tiotropium inhalation solution.
  8. Pregnant or nursing adolescent female patients, including female patients with a positive Beta HCG (serum pregnancy) testing at screening (visit 1).
  9. Sexually active female patients of child-bearing potential not using a highly effective method of birth control.
  10. Patients with a known narrow-angle glaucoma, or any other disease where anticholinergic treatment is contraindicated.
  11. Patients with renal impairment, as defined by a creatinine clearance less than 50 mL/min/1.73 m2 body surface area (BSA) as calculated by Schwartz Formula.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 12 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Latvia,   Lithuania,   Slovenia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01122680
Other Study ID Numbers  ICMJE 205.424
2009-017745-55 ( 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 July 2012

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