A Phase II randomised, double-blind, placebo-controlled, incompletecrossover trial with 4-week treatment periods to evaluate efficacy andsafety of tiotropium inhalation solution (doses of 1.25µg, 2.5µg and 5µg) delivered via Respimat® inhaler once daily in the evening in adolescents(12 to 17 yrs old) with moderate persistent asthma

Boehringer Ingelheim Pharma GmbH & Co. KG0 sites92 target enrollmentApril 26, 2010

ConditionsModerate persistent asthma in adolescents (12 to 17 years old)MedDRA version: 12.1Level: LLTClassification code 10003555Term: Asthma bronchial

DrugsSpiriva Respimat 2.5 microgram, solution for inhalation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Moderate persistent asthma in adolescents (12 to 17 years old)
Sponsor: Boehringer Ingelheim Pharma GmbH & Co. KG
Enrollment: 92
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

April 26, 2010

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Boehringer Ingelheim Pharma GmbH & Co. KG

Eligibility Criteria

Inclusion Criteria

•1\. All patients and parents (or legally accepted caregiver) must sign and date an Informed Consent Form consistent with ICH\-GCP guidelines and local legislation prior to participation in the trial, i.e. prior to any study procedures including medication washout and restrictions. A separate informed consent is required for pharmacogenomic sampling (consent for pharmacogenomic sampling is not a prerequisite for study entry).
•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 at the time of enrolment into the trial. The diagnosis must have been confirmed in the past and should be documented by at least one of the following criteria that were adapted from GINA 2008:
•an increased hyperresponsiveness to histamine, metacholine, mannitol or exercise challenge or
•a positive trial of glucocorticosteroids or a bronchodilator reversibility to a beta\-2\-adrenergic drug resulting in a FEV1 increase of \=12% and 200 mL\* or resulting in a PEF increase of \=20% or
•a diurnal PEF variability of \=10% (twice daily measurements) or \=20% (more than 2 PEF assessments per day). Diurnal variability is defined as the amplitude (difference between maximum and minimum value for the day) expressed as percentage of the mean daily PEF value and averaged over 7 to 14 days or
•a bronchodilator reversibility to a beta\-2\-adrenergic drug resulting in a FEV1 increase of \=12% and 200 mL\* at Visit 1, as per inclusion criterion No.7
•\*please refer to inclusion criterion No.7 for exceptions
•3\. All patients must have a documented history of at least 3 months of asthma and fulfill the diagnostic criteria of moderate persistent asthma, according to the current 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 (i.e., \=400 µg to \=800 µg budesonide or equivalent (see protocol table 3\.3\.1: 1\), either as mono treatment or in combination with a LABA or leukotriene modifier for at least 4 weeks before Visit 1\. While the LTRA is permitted throughout the trial, the LABA has to be stopped at least 24 hours prior to Visit 1, as no LABAs are permitted during the run\-in and treatment periods of this trial.

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 clinically relevant abnormal screening haematology or blood chemistry will be excluded if the abnormality defines a significant disease as defined in exclusion criterion 1\. For participation in PK sampling, a haemoglobin of less than 12\.5 g/dl for female patients and less than 13\.5 g/dl for male patients will be regarded as exclusion criterion.
•3\. Patients with a history of congenital or acquired heart disease, and/or 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 (pacemaker implantation, catheter ablation etc.) or a change in drug therapy within the past year.
•5\. Patients with malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years.
•6\. Patients with lung diseases other than asthma (e.g. CF). In case of ex\-premature infants, a history of significant bronchopulmonary dysplasia (BPD) will be regarded as exclusion criterion.
•7\. Patients with known active tuberculosis.
•8\. Patients with significant alcohol or drug abuse within the past two 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 who are currently in a pulmonary rehabilitation program or have completed a pulmonary rehabilitation program in the 6 weeks prior to the screening visit (Visit 1\).