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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tiotropium Respimat (low dose) | Experimental | Tiotropium low dose once daily delivered with Respimat inhaler |
|
| Tiotropium Respimat (high dose) | Experimental | Tiotropium high dose once daily delivered with Respimat inhaler |
|
| Placebo Respimat | Placebo Comparator | Tiotropium placebo once daily delivered with Respimat inhaler |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tiotropium Respimat | Drug | Tiotropium high dose once daily delivered with Respimat inhaler |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Drug-related Adverse Events | The primary endpoint is the 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Trough FEV1 Response | Trough FEV1 response was defined as change from baseline at week 52 | baseline and week 52 |
| Trough FVC Response | Trough FVC response was defined as change from baseline at week 52 |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 205.464.81020 Boehringer Ingelheim Investigational Site | Asahikawa, Hokkaido | Japan | ||||
| 205.464.81031 Boehringer Ingelheim Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36472162 | Derived | Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2. | |
| 31319851 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Respimat | Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler |
| FG001 | Tiotropium Respimat (2.5 µg) | Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo Respimat | Drug | Tiotropium placebo once daily delivered with Respimat inhaler |
|
| Tiotropium Respimat | Drug | Tiotropium low dose once daily delivered with Respimat inhaler |
|
| baseline and week 52 |
| Trough PEF Response | Trough PEF response was defined as change from baseline at week 52 | baseline and week 52 |
| Weekly Mean PEFam Response | Weekly mean PEFam response was defined as change from baseline at week 52 | baseline and week 52 |
| Weekly Mean PEFpm Response | Weekly mean PEFpm response was defined as change from baseline at week 52 | 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. | 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. | 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. | 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. | baseline and week 52 |
| 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 |
| 205.464.81051 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 |
| 205.464.81040 Boehringer Ingelheim Investigational Site | Himeji, Hyogo | Japan |
| 205.464.81041 Boehringer Ingelheim Investigational Site | Himeji, Hyogo | Japan |
| 205.464.81053 Boehringer Ingelheim Investigational Site | Himeji, Hyogo | Japan |
| 205.464.81007 Boehringer Ingelheim Investigational Site | Hino, Tokyo | Japan |
| 205.464.81015 Boehringer Ingelheim Investigational Site | Hiroshima, Hiroshima | Japan |
| 205.464.81002 Boehringer Ingelheim Investigational Site | Hitachinaka, Ibaraki | Japan |
| 205.464.81048 Boehringer Ingelheim Investigational Site | Iizuka, Fukuoka | Japan |
| 205.464.81005 Boehringer Ingelheim Investigational Site | Itabashi-ku, Tokyo | Japan |
| 205.464.81033 Boehringer Ingelheim Investigational Site | Kaga, Ishikawa | Japan |
| 205.464.81017 Boehringer Ingelheim Investigational Site | Kagoshima, Kagoshima | Japan |
| 205.464.81023 Boehringer Ingelheim Investigational Site | Kamogawa, Chiba | Japan |
| 205.464.81024 Boehringer Ingelheim Investigational Site | Kisarazu, Chiba | Japan |
| 205.464.81047 Boehringer Ingelheim Investigational Site | Kitakyusyu,Fukuoka | Japan |
| 205.464.81008 Boehringer Ingelheim Investigational Site | Kiyose, Tokyo | Japan |
| 205.464.81046 Boehringer Ingelheim Investigational Site | Kochi, Kochi | Japan |
| 205.464.81025 Boehringer Ingelheim Investigational Site | Kodaira, Tokyo | Japan |
| 205.464.81022 Boehringer Ingelheim Investigational Site | Koshigaya, Saitama | Japan |
| 205.464.81043 Boehringer Ingelheim Investigational Site | Kurashiki, Okayama | Japan |
| 205.464.81044 Boehringer Ingelheim Investigational Site | Kure, Hiroshima | 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 |
| 205.464.81042 Boehringer Ingelheim Investigational Site | Matsue, Shimane | Japan |
| 205.464.81026 Boehringer Ingelheim Investigational Site | Minato-ku, Tokyo | Japan |
| 205.464.81012 Boehringer Ingelheim Investigational Site | Nagoya, Aichi | Japan |
| 205.464.81013 Boehringer Ingelheim Investigational Site | Nagoya, Aichi | Japan |
| 205.464.81034 Boehringer Ingelheim Investigational Site | Nagoya, Aichi | Japan |
| 205.464.81035 Boehringer Ingelheim Investigational Site | Nagoya, Aichi | Japan |
| 205.464.81036 Boehringer Ingelheim Investigational Site | Nagoya, Aichi | Japan |
| 205.464.81037 Boehringer Ingelheim Investigational Site | Nagoya, Aichi | Japan |
| 205.464.81001 Boehringer Ingelheim Investigational Site | Obihiro, Hokkaido | Japan |
| 205.464.81018 Boehringer Ingelheim Investigational Site | Obihiro, Hokkaido | Japan |
| 205.464.81054 Boehringer Ingelheim Investigational Site | Oita, Oita | Japan |
| 205.464.81055 Boehringer Ingelheim Investigational Site | Oita, Oita | Japan |
| 205.464.81039 Boehringer Ingelheim Investigational Site | Osaka, Osaka | Japan |
| 205.464.81049 Boehringer Ingelheim Investigational Site | Saga, Saga | Japan |
| 205.464.81019 Boehringer Ingelheim Investigational Site | Sapporo, Hokkaido | 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 |
| 205.464.81045 Boehringer Ingelheim Investigational Site | Toon, Ehime | Japan |
| 205.464.81009 Boehringer Ingelheim Investigational Site | Yokohama, Kanagawa | Japan |
| 205.464.81052 Boehringer Ingelheim Investigational Site | Yokohama, Kanagawa | Japan |
| 205.464.81030 Boehringer Ingelheim Investigational Site | Yokosuka, Kanagawa | Japan |
| 205.464.81032 Boehringer Ingelheim Investigational Site | Zama | Japan |
| Derived |
| Halpin DMG, Meltzer EO, Pisternick-Ruf W, Moroni-Zentgraf P, Engel M, Zaremba-Pechmann L, Casale T, FitzGerald JM. Peak expiratory flow as an endpoint for clinical trials in asthma: a comparison with FEV1. Respir Res. 2019 Jul 18;20(1):159. doi: 10.1186/s12931-019-1119-6. |
| 25894430 | Derived | Ohta K, Ichinose M, Tohda Y, Engel M, Moroni-Zentgraf P, Kunimitsu S, Sakamoto W, Adachi M. Long-Term Once-Daily Tiotropium Respimat(R) Is Well Tolerated and Maintains Efficacy over 52 Weeks in Patients with Symptomatic Asthma in Japan: A Randomised, Placebo-Controlled Study. PLoS One. 2015 Apr 20;10(4):e0124109. doi: 10.1371/journal.pone.0124109. eCollection 2015. |
| FG002 | Tiotropium Respimat (5 μg) | Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Respimat | Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler |
| BG001 | Tiotropium Respimat (2.5 µg) | Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler |
| BG002 | Tiotropium Respimat (5 μg) | Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients With Drug-related Adverse Events | The primary endpoint is the number of patients with drug-related adverse events | Treated set: all randomised patients who received at least 1 dose of study medication | Posted | Number | participants | after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 |
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| ||||||||||||||||||||||||||||||||
| Secondary | Trough FEV1 Response | Trough FEV1 response was defined as change from baseline at week 52 | Full analysis set: all patients of the treated set for which baseline and at least 1 post-baseline efficacy measurement were available | Posted | Least Squares Mean | Standard Error | Liter | baseline and week 52 |
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| ||||||||||||||||||||||||||||||||
| Secondary | Trough FVC Response | Trough FVC response was defined as change from baseline at week 52 | Full analysis set | Posted | Least Squares Mean | Standard Error | Liter | baseline and week 52 |
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| ||||||||||||||||||||||||||||||||
| Secondary | Trough PEF Response | Trough PEF response was defined as change from baseline at week 52 | Full analysis set | Posted | Least Squares Mean | Standard Error | L/min | baseline and week 52 |
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| ||||||||||||||||||||||||||||||||
| Secondary | Weekly Mean PEFam Response | Weekly mean PEFam response was defined as change from baseline at week 52 | Full analysis set | Posted | Least Squares Mean | Standard Error | L/min | baseline and week 52 |
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| ||||||||||||||||||||||||||||||||
| Secondary | Weekly Mean PEFpm Response | Weekly mean PEFpm response was defined as change from baseline at week 52 | Full analysis set | Posted | Least Squares Mean | Standard Error | L/min | baseline and week 52 |
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| Secondary | 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. | Full analysis set | Posted | Least Squares Mean | Standard Error | percentage | baseline and week 52 |
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| Secondary | 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. | Full analysis set | Posted | Mean | Standard Deviation | Puffs | baseline and week 52 |
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| Secondary | 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. | Full analysis set | Posted | Mean | Standard Deviation | Scores on a scale | baseline and week 52 |
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| Secondary | 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. | Full analysis set | Posted | Mean | Standard Deviation | Scores on a scale | baseline and week 52 |
|
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after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo Respimat | Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler | 9 | 57 | 50 | 57 | ||
| EG001 | Tiotropium Respimat (2.5 µg) | Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler | 4 | 114 | 97 | 114 | ||
| EG002 | Tiotropium Respimat (5 μg) | Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler | 4 | 114 | 101 | 114 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mesenteric haemorrhage | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
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| Subileus | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
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| Cyst | General disorders | MEDDRA 16.0 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
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| Diverticulitis | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
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| Influenza | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
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| Pneumonia bacterial | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
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| Rib fracture | Injury, poisoning and procedural complications | MEDDRA 16.0 | Systematic Assessment |
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| Sternal fracture | Injury, poisoning and procedural complications | MEDDRA 16.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MEDDRA 16.0 | Systematic Assessment |
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| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MEDDRA 16.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MEDDRA 16.0 | Systematic Assessment |
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| Oral papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 16.0 | Systematic Assessment |
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| Loss of consciousness | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
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| Ovarian cyst | Reproductive system and breast disorders | MEDDRA 16.0 | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
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| Aortic dissection | Vascular disorders | MEDDRA 16.0 | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
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| Influenza | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
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| Ligament sprain | Injury, poisoning and procedural complications | MEDDRA 16.0 | Systematic Assessment |
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| Peak expiratory flow rate decreased | Investigations | MEDDRA 16.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MEDDRA 16.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
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| Dysphonia | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
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| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
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| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000611386 | tiotropium-olodaterol |
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| Male |
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