The aim of this trial is to evaluate the safety and efficacy of 2.5 and 5 µg tiotropium over a 52-week treatment period as compared to placebo. Tiotropium inhalation solution delivered by the Respimat inhaler will be examined on top of maintenance treatment with inhaled corticosteroid controller medication in patients with moderate to severe persistent asthma. Efficacy and safety will be assessed by measuring effects on lung function, effects on asthma exacerbations, effects on asthma control, and number of adverse events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
285
Tiotropium high dose once daily delivered with Respimat inhaler
Tiotropium placebo once daily delivered with Respimat inhaler
Tiotropium low dose once daily delivered with Respimat inhaler
205.464.81020 Boehringer Ingelheim Investigational Site
Asahikawa, Hokkaido, Japan
205.464.81031 Boehringer Ingelheim Investigational Site
Atsugi, Kanagawa, Japan
205.464.81029 Boehringer Ingelheim Investigational Site
Chigasaki, Kanagawa, Japan
205.464.81011 Boehringer Ingelheim Investigational Site
Chino, Nagano, Japan
205.464.81050 Boehringer Ingelheim Investigational Site
Chuo-ku, Tokyo, Japan
Number of Patients With Drug-related Adverse Events
The primary endpoint is the number of patients with drug-related adverse events
Time frame: after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409
Trough FEV1 Response
Trough FEV1 response was defined as change from baseline at week 52
Time frame: baseline and week 52
Trough FVC Response
Trough FVC response was defined as change from baseline at week 52
Time frame: baseline and week 52
Trough PEF Response
Trough PEF response was defined as change from baseline at week 52
Time frame: baseline and week 52
Weekly Mean PEFam Response
Weekly mean PEFam response was defined as change from baseline at week 52
Time frame: baseline and week 52
Weekly Mean PEFpm Response
Weekly mean PEFpm response was defined as change from baseline at week 52
Time frame: baseline and week 52
Weekly Mean PEF Variability Response
Weekly mean PEF variability response was defined as change from baseline at week 52. The PEF variability is the absolute difference between morning and evening PEF value, divided by their mean, expressed as a percent. Response was defined as change from baseline.
Time frame: baseline and week 52
Weekly Mean Number of Puffs of Rescue Medication During the Whole Day (Response)
Response of weekly mean number of puffs of rescue medication during the whole day at week 52. Response was defined as change from baseline.
Time frame: baseline and week 52
Weekly Mean Score of Asthma Symptoms in the Morning (Response)
Response of weekly mean score of asthma symptoms in the morning at week 52. Response was defined as change from baseline. 5-point verbal rating scale, with answer 1 representing no impairment at all and answer 5 representing the greatest impairment.
Time frame: baseline and week 52
Weekly Mean Score of Asthma Symptoms During the Day (Response)
Response of weekly mean score of asthma symptoms during the day at week 52. Response was defined as change from baseline. 5-point verbal rating scale, with answer 1 representing no impairment at all and answer 5 representing the greatest impairment.
Time frame: baseline and week 52
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205.464.81051 Boehringer Ingelheim Investigational Site
Chuo-ku, Tokyo, Japan
205.464.81006 Boehringer Ingelheim Investigational Site
Edogawa-ku, Tokyo, Japan
205.464.81010 Boehringer Ingelheim Investigational Site
Fujisawa, Kanagawa, Japan
205.464.81016 Boehringer Ingelheim Investigational Site
Fukuoka, Fukuoka, Japan
205.464.81004 Boehringer Ingelheim Investigational Site
Hanno, Saitama, Japan
...and 45 more locations