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

Phase 3

Completed

• Conditions: Asthma
• Interventions: Drug: Tiotropium Respimat; Drug: Placebo Respimat

• 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

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-04-13
• Study First Submitted QC: 2011-04-21
• Study First Posted: 2011-04-22
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Results First Submitted: 2014-04-22
• Status Verified: 2014-06
• Results First Submitted QC: 2014-06-04
• Last Update Submitted: 2014-06-04
• Results First Posted: 2014-07-04
• Last Update Posted: 2014-07-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 285

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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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