Evaluation of Tiotropium 2.5 and 5 µg Once Daily Delivered Via the Respimat Inhaler Compared to Placebo in Patient With Moderate to Severe Persistent Asthma
- Registration Number
- NCT01340209
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 285
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tiotropium Respimat (low dose) Tiotropium Respimat Tiotropium low dose once daily delivered with Respimat inhaler Tiotropium Respimat (high dose) Tiotropium Respimat Tiotropium high dose once daily delivered with Respimat inhaler Placebo Respimat Placebo Respimat Tiotropium placebo once daily delivered with Respimat inhaler
- Primary Outcome Measures
Name Time Method Number of Patients With Drug-related Adverse Events after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 The primary endpoint is the number of patients with drug-related adverse events
- Secondary Outcome Measures
Name Time Method Weekly Mean Number of Puffs of Rescue Medication During the Whole Day (Response) baseline and week 52 Response of weekly mean number of puffs of rescue medication during the whole day at week 52. Response was defined as change from baseline.
Trough FEV1 Response baseline and week 52 Trough FEV1 response was defined as change from baseline at week 52
Trough PEF Response baseline and week 52 Trough PEF response was defined as change from baseline at week 52
Trough FVC Response baseline and week 52 Trough FVC response was defined as change from baseline at week 52
Weekly Mean PEFpm Response baseline and week 52 Weekly mean PEFpm response was defined as change from baseline at week 52
Weekly Mean Score of Asthma Symptoms During the Day (Response) baseline and week 52 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.Weekly Mean Score of Asthma Symptoms in the Morning (Response) baseline and week 52 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.Weekly Mean PEFam Response baseline and week 52 Weekly mean PEFam response was defined as change from baseline at week 52
Weekly Mean PEF Variability Response baseline and week 52 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.
Trial Locations
- Locations (55)
205.464.81006 Boehringer Ingelheim Investigational Site
🇯🇵Edogawa-ku, Tokyo, Japan
205.464.81002 Boehringer Ingelheim Investigational Site
🇯🇵Hitachinaka, Ibaraki, Japan
205.464.81023 Boehringer Ingelheim Investigational Site
🇯🇵Kamogawa, Chiba, Japan
205.464.81021 Boehringer Ingelheim Investigational Site
🇯🇵Sendai, Miyagi, Japan
205.464.81027 Boehringer Ingelheim Investigational Site
🇯🇵Setagaya-Ku, Tokyo, Japan
205.464.81028 Boehringer Ingelheim Investigational Site
🇯🇵Setagaya-ku, Tokyo, 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
205.464.81004 Boehringer Ingelheim Investigational Site
🇯🇵Hanno, Saitama, Japan
205.464.81024 Boehringer Ingelheim Investigational Site
🇯🇵Kisarazu, Chiba, Japan
205.464.81012 Boehringer Ingelheim Investigational Site
🇯🇵Nagoya, Aichi, Japan
205.464.81054 Boehringer Ingelheim Investigational Site
🇯🇵Oita, Oita, Japan
205.464.81032 Boehringer Ingelheim Investigational Site
🇯🇵Zama, Kanagawa, Japan
205.464.81010 Boehringer Ingelheim Investigational Site
🇯🇵Fujisawa, Kanagawa, Japan
205.464.81040 Boehringer Ingelheim Investigational Site
🇯🇵Himeji, Hyogo, Japan
205.464.81033 Boehringer Ingelheim Investigational Site
🇯🇵Kaga, Ishikawa, Japan
205.464.81047 Boehringer Ingelheim Investigational Site
🇯🇵Kitakyusyu,Fukuoka, Japan
205.464.81041 Boehringer Ingelheim Investigational Site
🇯🇵Himeji, Hyogo, Japan
205.464.81025 Boehringer Ingelheim Investigational Site
🇯🇵Kodaira, Tokyo, Japan
205.464.81043 Boehringer Ingelheim Investigational Site
🇯🇵Kurashiki, Okayama, Japan
205.464.81034 Boehringer Ingelheim Investigational Site
🇯🇵Nagoya, Aichi, Japan
205.464.81001 Boehringer Ingelheim Investigational Site
🇯🇵Obihiro, Hokkaido, Japan
205.464.81042 Boehringer Ingelheim Investigational Site
🇯🇵Matsue, Shimane, Japan
205.464.81026 Boehringer Ingelheim Investigational Site
🇯🇵Minato-ku, Tokyo, Japan
205.464.81013 Boehringer Ingelheim Investigational Site
🇯🇵Nagoya, Aichi, Japan
205.464.81036 Boehringer Ingelheim Investigational Site
🇯🇵Nagoya, Aichi, Japan
205.464.81019 Boehringer Ingelheim Investigational Site
🇯🇵Sapporo, Hokkaido, Japan
205.464.81055 Boehringer Ingelheim Investigational Site
🇯🇵Oita, Oita, Japan
205.464.81020 Boehringer Ingelheim Investigational Site
🇯🇵Asahikawa, Hokkaido, Japan
205.464.81048 Boehringer Ingelheim Investigational Site
🇯🇵Iizuka, Fukuoka, Japan
205.464.81035 Boehringer Ingelheim Investigational Site
🇯🇵Nagoya, Aichi, Japan
205.464.81018 Boehringer Ingelheim Investigational Site
🇯🇵Obihiro, Hokkaido, Japan
205.464.81049 Boehringer Ingelheim Investigational Site
🇯🇵Saga, Saga, Japan
205.464.81009 Boehringer Ingelheim Investigational Site
🇯🇵Yokohama, Kanagawa, Japan
205.464.81053 Boehringer Ingelheim Investigational Site
🇯🇵Himeji, Hyogo, Japan
205.464.81007 Boehringer Ingelheim Investigational Site
🇯🇵Hino, Tokyo, Japan
205.464.81005 Boehringer Ingelheim Investigational Site
🇯🇵Itabashi-ku, Tokyo, Japan
205.464.81008 Boehringer Ingelheim Investigational Site
🇯🇵Kiyose, Tokyo, Japan
205.464.81022 Boehringer Ingelheim Investigational Site
🇯🇵Koshigaya, Saitama, Japan
205.464.81044 Boehringer Ingelheim Investigational Site
🇯🇵Kure, Hiroshima, Japan
205.464.81051 Boehringer Ingelheim Investigational Site
🇯🇵Chuo-ku, Tokyo, Japan
205.464.81016 Boehringer Ingelheim Investigational Site
🇯🇵Fukuoka, Fukuoka, Japan
205.464.81015 Boehringer Ingelheim Investigational Site
🇯🇵Hiroshima, Hiroshima, Japan
205.464.81017 Boehringer Ingelheim Investigational Site
🇯🇵Kagoshima, Kagoshima, Japan
205.464.81046 Boehringer Ingelheim Investigational Site
🇯🇵Kochi, Kochi, Japan
205.464.81014 Boehringer Ingelheim Investigational Site
🇯🇵Kyoto, Kyoto, Japan
205.464.81038 Boehringer Ingelheim Investigational Site
🇯🇵Kyoto, Kyoto, Japan
205.464.81003 Boehringer Ingelheim Investigational Site
🇯🇵Maebashi, Gumma, Japan
205.464.81037 Boehringer Ingelheim Investigational Site
🇯🇵Nagoya, Aichi, Japan
205.464.81039 Boehringer Ingelheim Investigational Site
🇯🇵Osaka, Osaka, Japan
205.464.81045 Boehringer Ingelheim Investigational Site
🇯🇵Toon, Ehime, Japan
205.464.81052 Boehringer Ingelheim Investigational Site
🇯🇵Yokohama, Kanagawa, Japan
205.464.81030 Boehringer Ingelheim Investigational Site
🇯🇵Yokosuka, Kanagawa, Japan