Moderate persistent asthma MedDRA version: 13.1 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Sponsors
Boehringer Ingelheim RCV GmbH&Co KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Outpatients of either sex, aged 18-75 years Diagnosis of moderate persistent asthma. Asthma diagnosis made before age of 40. At leaset a 3 month history of asthma. Pre-bronchodilator FEV1 = 60% and = 90% of predicted at Visit 1. Increase in FEV1 of = 12% and = 200 mL 15 to 30 min after 400 µg salbutamol (albuterol) at Visit 1. Maintenance treatment with medium dose of inhaled corticosteroids for at least 4 weeks before Visit 1. Symptomatic despite their current maintenance treatment with ICS (ACQ = 1.5). Variation in absolute pre-BD FEV1 values Visit 1 compared to Visit 2 within ± 30%. Never-smokers or ex-smokers (stopped at least one year prior to enrolment + smoking history of less than 10 pack years). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 900 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: Patients with a significant disease other than asthma. Patients with a clinically relevant abnormal screening haematology or blood chemistry if the abnormalitiy defines a significant disease. Patients with a recent history (i.e. six months or less) of myocardial infarction. Patients who have been hospitalised for cardiac 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 lung diseases other than asthma (e.g. COPD). Patients with known active tuberculosis. 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. 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. Patients with significant alcohol or drug abuse within the past two years. Patients who are currently in a pulmonary rehabilitation program or have completed a pulmonary rehabilitation program in the 6 weeks prior to Visit 1 (screening). Pregnant or nursing woman. Women of childbearing potential not using a highly effective method of birth control. Patients with any asthma exacerbation or any respiratory tract infection in the four weeks prior to Visit 1 or during the screening period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the long term (24 weeks) efficacy of two doses (2.5 µg and 5 µg) of tiotropium inhalation solution (administered once daily) compared to placebo and to salmeterol (50 µg; administered twice daily) on top of maintenance therapy with inhaled corticosteroid controller medication in patients with moderate persistent asthma. ;Secondary Objective: Evaluate the long term (24 weeks) safety of two doses (2.5 µg and 5 µg) of tiotropium inhalation solution (administered once daily) compared to placebo and to salmeterol (50 µg; administered twice daily) on top of maintenance therapy with inhaled corticosteroid controller medication in patients with moderate persistent asthma.;Primary end point(s): The co-primary endpoints are 1. Peak forced expiratory volume in one second (FEV1) response (within 3 hours post dosing) determined at the end of the 24-week treatment period. 2. Trough forced expiratory volume in one second (FEV1) response determined at the end of the 24-week treatment period. Primary endpoint Meta-Analysis (combined data 205.418 and 205.419 trial): 1. The responder rate as assessed by the Asthma Control Questionnaire (ACQ) determined at the end of the 24-week treatment period on combined data from the two twin trials 205.418 and 205.419.;Timepoint(s) of evaluation of this end point: At 24 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Peak (within 3 hours post dosing) and trough forced vital capacity (FVC) determined at the end of the 24-week treatment period. 2. FEV1 (AUC0-3h) and FVC (AUC0-3h) at the end of the 24-week treatment period. 3. Individual in-clinic FEV1, FVC and PEF measurements at all time points including peak, trough and AUC0-3h during the 24-week treatment period. 4. Quality of Life as assessed by standardised Asthma Quality of Life Questionnaire (AQLQ (S)) at all clinic visits during the 24-week treatment period. 5. PEF am/pm: change from baseline in mean weekly pre-dose morning and evening PEF measured by patients at home in the last week of the 24-week treatment period. 6. Use of PRN salbutamol (albuterol) rescue medication during the 24- week treatment period. 7. Asthma symptoms as assessed by the patient's electronic diary during the 24-week treatment period. 8. Asthma symptom free days as assessed by the patient's electronic diary during the 24-week treatment period. 9. The responder rate as assessed by the ACQ determined at the end of the 24-week treatment period for each trial separately. Additionally in a subset of patients: 10. FEV1 (AUC0-12h), FEV1 (AUC12-24h), FEV1 (AUC0-24h), FVC (AUC0-12h), FVC (AUC12-24h), FVC (AUC0-24h) after 24-week treatment 11. Individual FEV1 and FVC measurements at 5 and 15 minutes post dose including peak and AUC0-3h.;Timepoint(s) of evaluation of this end point: During or at the end of the 24 week treatment period | — |
Countries
Brazil, China, Guatemala, India, Japan, Latvia, Mexico, Peru, Poland, Russian Federation, United States
Contacts
Public ContactQRPE PSC CT Information Disclosure
Boehringer Ingelheim Pharma GmbH & Co. KG
Outcome results
None listed