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The objective of this trial is to compare the efficacy and the safety of Ba 679 BR Respimat 5 ug once daily to tiotropium inhalation capsule 18 ug (Spiriva inhalation capsule) in a crossover study of 4-week treatment periods in patients with COPD.
This is a 16-week, multi-centre, randomised, double-blind, double-dummy, crossover study of 4-week randomised treatment periods to demonstrate the efficacy and safety of 5 ug of Ba 679 BR inhalation solution from Respimat compared to tiotropium inhalation powder capsule (18 ug) via HandiHaler in patients with COPD. The two 4-week randomised treatment periods are separated by 4-week washout period.
Study Hypothesis:
The primary aim of this trial is to demonstrate non-inferiority of lung function response to 5 ug (2 actuations of 2.5 ug) of Ba679BR Respimat delivered by the Respimat inhaler once daily compared to tiotropium (18 ug) inhaled as powder capsule from the HandiHaler once daily at the end of 4-week treatment periods in patients with COPD. The hypothesis test of non-inferiority will be performed at alpha = 0.025 (one-sided).
Comparison(s):
The primary efficacy endpoint is the trough FEV1 response determined at the end of each 4-week period of randomised treatment.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ba 679 BR Respimat | Drug | |||
| Tiotropium (Spiriva) inhalation capsule 18 ug | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome is the trough FEV1 response determined at the end of each 4-week period of randomised treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Trough FVC response after 4 weeks, peak response (FEV1 and FVC) to first dose, peak response (FEV1 and FVC) after 4 weeks, FEV1 AUC0-3h and FVC AUC0-3h response to first dose and after 4 weeks, individual FEV1and FVC measurements at each time point. |
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participation in the trial 2. All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria:
? Patients must have relatively stable, moderate to severe airway obstruction with an FEV1 =< 70% of predicted normal* and FEV1 =< 70% of FVC (Visits 1 and 2).
*: Predicted normal values will be calculated according to the formulas for Japanese predicted normal values (R05-0607) (see below).
Males: FEV1 predicted (L) = 0.036 x (height (cm)) ? 0.028 x age (years) ? 1.178 Females: FEV1 predicted (L) = 0.022 x (height (cm)) ? 0.022 x age (years) ? 0.005
? Patients must maintain stable COPD medications for 1 month prior to Visit 1. 3. Male or female patients 40 years of age or older. 4. Patients must be current or ex-smokers with a smoking history of more than 10 pack years.
Pack Years = [Number of cigarettes/ day / 20] x years of smoking 5. Patients must be able to perform technically acceptable pulmonary function tests.
6. Patients must be able to inhale medication in a competent manner from the Respimat inhaler and the HandiHaler.
Patients with/who:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim Study Coordinator | Nippon Boehringer Ingelheim Co., Ltd. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boehringer Ingelheim Investigational Site | Akita, Akita | 010-1495 | Japan | |||
| Boehringer Ingelheim Investigational Site |
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| Bunkyo-ku, Tokyo |
| 113-8431 |
| Japan |
| Boehringer Ingelheim Investigational Site | Bunkyo-ku,Tokyo | 113-0022 | Japan |
| Boehringer Ingelheim Investigational Site | Habikino, Osaka | 583-8588 | Japan |
| Boehringer Ingelheim Investigational Site | Inashiki-gun, Ibaraki | 300-0395 | Japan |
| Boehringer Ingelheim Investigational Site | Itami, Hyogo | 664-8540 | Japan |
| Boehringer Ingelheim Investigational Site | Kamogawa, Chiba | 296-0041 | Japan |
| Boehringer Ingelheim Investigational Site | Kishiwada, Osaka | 596-8501 | Japan |
| Boehringer Ingelheim Investigational Site | Komaki, Aichi | 485-0044 | Japan |
| Boehringer Ingelheim Investigational Site | Kurume, Fukuoka | 830-0011 | Japan |
| Boehringer Ingelheim Investigational Site | Kyoto, Kyoto | 606-8507 | Japan |
| Boehringer Ingelheim Investigational Site | Matsumoto, Nagano | 390-8621 | Japan |
| Boehringer Ingelheim Investigational Site | Morioka, Iwate | 020-8505 | Japan |
| Boehringer Ingelheim Investigational Site | Osaka, Osaka | 545-8586 | Japan |
| Boehringer Ingelheim Investigational Site | Osakasayama, Osaka | 589-0014 | Japan |
| Boehringer Ingelheim Investigational Site | Sakai, Osaka | 591-8555 | Japan |
| Boehringer Ingelheim Investigational Site | Sendai, Miyagi | 980-8574 | Japan |
| Boehringer Ingelheim Investigational Site | Sendai, Miyagi | 981-8563 | Japan |
| Boehringer Ingelheim Investigational Site | Sendai, Miyagi | 984-8560 | Japan |
| Boehringer Ingelheim Investigational Site | Seto, Aichi | 489-8642 | Japan |
| Boehringer Ingelheim Investigational Site | Shinjuku-ku, Tokyo | 160-8582 | Japan |
| Boehringer Ingelheim Investigational Site | Takatsuki, Osaka | 569-1096 | Japan |
| Boehringer Ingelheim Investigational Site | Toyonaka, Osaka | 560-8552 | Japan |
| Boehringer Ingelheim Investigational Site | Tsukuba, Ibaraki | 305-8576 | Japan |
| Boehringer Ingelheim Investigational Site | Wakayama, Wakayama | 641-0012 | Japan |
| Boehringer Ingelheim Investigational Site | Yokohama, Kanagawa | 236-0051 | Japan |
| Boehringer Ingelheim Investigational Site | Yokote, Akita | 013-8610 | Japan |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069447 | Tiotropium Bromide |
| D001239 | Inhalation |
| ID | Term |
|---|---|
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D015656 | Respiratory Mechanics |
| D012119 | Respiration |
| D012143 | Respiratory Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
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