Status:
COMPLETED
Efficacy and Safety of 2 Doses of Tiotropium Via Respimat Compared to Placebo in Adolescents With Moderate Persistent Asthma
Lead Sponsor:
Boehringer Ingelheim
Collaborating Sponsors:
Pfizer
Conditions:
Asthma
Eligibility:
All Genders
12-17 years
Phase:
PHASE3
Brief Summary
The aim of the study is to evaluate efficacy and safety of a 48-week treatment with two doses of tiotropium bromide compared to placebo in adolescent patients with moderate persistent asthma. Efficacy...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- All patients and their parents (or legally accepted caregiver) must sign and date an informed consent consistent with ICH-GCP guidelines and local legislation prior to participation in the trial.
- Male or female patients between 12 and 17 years of age.
- 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 test.
- All patients must have been on maintenance treatment with inhaled corticosteroids at a stable medium dose for at least 4 weeks before Visit 1.
- All patients must be symptomatic (partly controlled) at Visit 1 (screening) and at randomisation defined by an Asthma Control Questionnaire (ACQ) mean score of more than or equal to 1.5.
- All patients must have a pre-bronchodilator FEV1 more than or equal to 60% and less than or equal to 90% of predicted normal at Visit 1. Variation of absolute FEV1 values of Visit 1 as compared to Visit 2 must be within ± 30%.
- All patients must have an increase in FEV1 of equal or above 12% and 200 mL after 400 µg 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.
- All patients should be never-smokers or ex-smokers who stopped smoking at least one year prior to enrolment.
- Patients should be able to use the Respimat® inhaler correctly.
- Patients must be able to perform all trial related procedures including technically acceptable spirometric manoeuvres.
- Exclusion criteria:
- Patients with a significant disease other than asthma.
- Patients with clinically relevant abnormal screening haematology or blood chemistry
- Patients with a history of congenital or acquired heart disease, and/or have been hospitalised for cardiac syncope or failure during the past year.
- Patients with any unstable or life-threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year.
- Patients with malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years.
- Patients with lung diseases other than asthma (e.g. Cystic Fibrosis). In case of ex-premature infants, a history of significant bronchopulmonary dysplasia will be regarded as exclusion criterion.
- Patients with known active tuberculosis.
- Patients with significant alcohol or drug abuse within the past two years.
- Patients who have undergone thoracotomy with pulmonary resection.
- 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).
- Patients with known hypersensitivity to anticholinergic drugs, Benzalkonium chloride (BAC), Ethylenediaminetetraacetic acis (EDTA) or any other components of the tiotropium inhalation solution.
- Pregnant or nursing adolescent female patients
- Sexually active female patients of child-bearing potential not using a highly effective method of birth control.
- Patients who have taken an investigational drug within 4 weeks prior to Visit 1.
- Patients who have been treated with long-acting anticholinergics (e.g. tiotropium -Spiriva) within four weeks prior to screening (Visit 1).
- Patients who are unable to comply with pulmonary medication restrictions prior to randomisation.
- Patients who have been treated with Anti-IgE treatment (Omalizumab Xolair) within the last 6 months prior to screening.
- Patients who have been treated with systemic (oral or intravenous) corticosteroids within 4 weeks prior to screening (Visit 1).
- Patients who have been treated with long-acting theophylline preparations within 2 weeks prior to screening (Visit 1) or during the run-in period
- Patients who have been treated with other non-approved and according to international guidelines not recommended ¿experimental¿ drugs for routine asthma therapy.
- Patients with any acute asthma exacerbation or respiratory tract infection in the 4 weeks prior to Visit 1.
- Patients requiring 10 or more puffs of rescue medication (salbutamol/albuterol) per day on more than 2 consecutive days during the run-in period.
- Patients who have previously been randomised in this trial or are currently participating in another study.
- Patients who are being treated with oral beta-blocker medication.
- Patients with a known narrow-angle glaucoma, or any other disease where anticholinergic treatment is contraindicated.
- Patients with renal impairment, as defined by a creatinine clearance less than 50 mL/min/1.73 m2 Body Surface Area as calculated by Schwartz formula.
Exclusion
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
398 Patients enrolled
Trial Details
Trial ID
NCT01257230
Start Date
December 1 2010
End Date
December 1 2013
Last Update
September 5 2014
Active Locations (66)
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1
205.444.01004 Boehringer Ingelheim Investigational Site
Plymouth, Minnesota, United States
2
205.444.01005 Boehringer Ingelheim Investigational Site
Columbia, Missouri, United States
3
205.444.01001 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio, United States
4
205.444.01014 Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma, United States