Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
Special Survey Long-term Treatment
| NCT number | NCT00638183 |
| Other study ID # | 205.315 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | March 11, 2008 |
| Last updated | June 18, 2014 |
| Start date | April 2005 |
| Verified date | June 2014 |
| Source | Boehringer Ingelheim |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Japan: Ministry of Health, Labor and Welfare |
| Study type | Observational |
Since Spiriva Inhalation Capsules 18mcg (hereinafter this product) are indicated for treatment of patients with chronic obstructive pulmonary disease (i.e. patients with chronic bronchitis or pulmonary emphysema) and usually intended for long-term use, the present survey is conducted to collect safety and effectiveness information on the use of this product for long period of time in daily clinical settings, and to obtain proper drug use information.
| Status | Completed |
| Enrollment | 385 |
| Est. completion date | |
| Est. primary completion date | January 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years and older |
| Eligibility |
Inclusion Criteria: 1. Patients of Chronic Obstructive Pulmonary Disease 2. Patients were expected to use the product for long period of time Exclusion Criteria: 1. Patients with glaucoma 2. Patients with micturition disorder due to prostatic hyperplasia etc. 3. Patients with a history of hypersensitivity to atropine or its derivatives or to any component of this product |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Japan | Boehringer Ingelheim Investigational Site | Asahikawa | |
| Japan | Boehringer Ingelheim Investigational Site | Chikushino | |
| Japan | Boehringer Ingelheim Investigational Site | Daito | |
| Japan | Boehringer Ingelheim Investigational Site | Ebina | |
| Japan | Boehringer Ingelheim Investigational Site | Echizen | |
| Japan | Boehringer Ingelheim Investigational Site | Fukui | |
| Japan | Boehringer Ingelheim Investigational Site | Fukushima | |
| Japan | Boehringer Ingelheim Investigational Site | Funabashi | |
| Japan | Boehringer Ingelheim Investigational Site | Gosen | |
| Japan | Boehringer Ingelheim Investigational Site | Habikino | |
| Japan | Boehringer Ingelheim Investigational Site | Hakodate | |
| Japan | Boehringer Ingelheim Investigational Site | Hayashimacho | |
| Japan | Boehringer Ingelheim Investigational Site | Higashiosakaka | |
| Japan | Boehringer Ingelheim Investigational Site | Himeji | |
| Japan | Boehringer Ingelheim Investigational Site | Hirosaki | |
| Japan | Boehringer Ingelheim Investigational Site | Hiroshima | |
| Japan | Boehringer Ingelheim Investigational Site | Hitachi | |
| Japan | Boehringer Ingelheim Investigational Site | Iizuka | |
| Japan | Boehringer Ingelheim Investigational Site | Ikoma | |
| Japan | Boehringer Ingelheim Investigational Site | Ishinomaki | |
| Japan | Boehringer Ingelheim Investigational Site | Itanocho | |
| Japan | Boehringer Ingelheim Investigational Site | Kasukabe | |
| Japan | Boehringer Ingelheim Investigational Site | Katsuragicho | |
| Japan | Boehringer Ingelheim Investigational Site | Kawasaki | |
| Japan | Boehringer Ingelheim Investigational Site | Kishiwada | |
| Japan | Boehringer Ingelheim Investigational Site | Kitakyushu | |
| Japan | Boehringer Ingelheim Investigational Site | Kobayashi | |
| Japan | Boehringer Ingelheim Investigational Site | Koga | |
| Japan | Boehringer Ingelheim Investigational Site | Komaki | |
| Japan | Boehringer Ingelheim Investigational Site | Komatsu | |
| Japan | Boehringer Ingelheim Investigational Site | Koshu | |
| Japan | Boehringer Ingelheim Investigational Site | Kumamoto | |
| Japan | Boehringer Ingelheim Investigational Site | Kunimicho | |
| Japan | Boehringer Ingelheim Investigational Site | Kyotango | |
| Japan | Boehringer Ingelheim Investigational Site | Kyoto | |
| Japan | Boehringer Ingelheim Investigational Site | Matsudo | |
| Japan | Boehringer Ingelheim Investigational Site | Matsue | |
| Japan | Boehringer Ingelheim Investigational Site | Matsumoto | |
| Japan | Boehringer Ingelheim Investigational Site | Mihamacho | |
| Japan | Boehringer Ingelheim Investigational Site | Minamiuonuma | |
| Japan | Boehringer Ingelheim Investigational Site | Mishima | |
| Japan | Boehringer Ingelheim Investigational Site | Mizumakimachi | |
| Japan | Boehringer Ingelheim Investigational Site | Morioka | |
| Japan | Boehringer Ingelheim Investigational Site | Nagaoka | |
| Japan | Boehringer Ingelheim Investigational Site | Nagasaki | |
| Japan | Boehringer Ingelheim Investigational Site | Nagoya | |
| Japan | Boehringer Ingelheim Investigational Site | Nichinan | |
| Japan | Boehringer Ingelheim Investigational Site | Niihama | |
| Japan | Boehringer Ingelheim Investigational Site | Nogata | |
| Japan | Boehringer Ingelheim Investigational Site | Numata | |
| Japan | Boehringer Ingelheim Investigational Site | Obihiro | |
| Japan | Boehringer Ingelheim Investigational Site | Obu | |
| Japan | Boehringer Ingelheim Investigational Site | Odawara | |
| Japan | Boehringer Ingelheim Investigational Site | Ogaki | |
| Japan | Boehringer Ingelheim Investigational Site | Okuchi | |
| Japan | Boehringer Ingelheim Investigational Site | Osaka | |
| Japan | Boehringer Ingelheim Investigational Site | Otsu | |
| Japan | Boehringer Ingelheim Investigational Site | Saiki | |
| Japan | Boehringer Ingelheim Investigational Site | Saitama | |
| Japan | Boehringer Ingelheim Investigational Site | Sakai | |
| Japan | Boehringer Ingelheim Investigational Site | Sakede | |
| Japan | Boehringer Ingelheim Investigational Site | Sapporo | |
| Japan | Boehringer Ingelheim Investigational Site | Sayama | |
| Japan | Boehringer Ingelheim Investigational Site | Sendai | |
| Japan | Boehringer Ingelheim Investigational Site | Shiroishi | |
| Japan | Boehringer Ingelheim Investigational Site | Shiroishicho | |
| Japan | Boehringer Ingelheim Investigational Site | Shizuoka | |
| Japan | Boehringer Ingelheim Investigational Site | Tagawa | |
| Japan | Boehringer Ingelheim Investigational Site | Takarazuka | |
| Japan | Boehringer Ingelheim Investigational Site | Tokyo Chiyoda-ku | |
| Japan | Boehringer Ingelheim Investigational Site | Tokyo Higashiyamato | |
| Japan | Boehringer Ingelheim Investigational Site | Tokyo Itabashi-ku | |
| Japan | Boehringer Ingelheim Investigational Site | Tokyo Kita-ku | |
| Japan | Boehringer Ingelheim Investigational Site | Tokyo Koto-ku | |
| Japan | Boehringer Ingelheim Investigational Site | Tokyo Meguro-ku | |
| Japan | Boehringer Ingelheim Investigational Site | Tokyo Otaku-ku | |
| Japan | Boehringer Ingelheim Investigational Site | Tokyo Shinjuku-ku | |
| Japan | Boehringer Ingelheim Investigational Site | Tsu | |
| Japan | Boehringer Ingelheim Investigational Site | Tsukuba | |
| Japan | Boehringer Ingelheim Investigational Site | Ube | |
| Japan | Boehringer Ingelheim Investigational Site | Uji | |
| Japan | Boehringer Ingelheim Investigational Site | Urayasu | |
| Japan | Boehringer Ingelheim Investigational Site | Uruma | |
| Japan | Boehringer Ingelheim Investigational Site | Utsunomiya | |
| Japan | Boehringer Ingelheim Investigational Site | Yamagata | |
| Japan | Boehringer Ingelheim Investigational Site | Yame | |
| Japan | Boehringer Ingelheim Investigational Site | Yokohama | |
| Japan | Boehringer Ingelheim Investigational Site | Yorocho | |
| Japan | Boehringer Ingelheim Investigational Site | Yurihonjo |
| Lead Sponsor | Collaborator |
|---|---|
| Boehringer Ingelheim |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Patients With Adverse Events (AEs) | Number of patients with AEs | Pre treatment and 52 weeks after the treatment | No |
| Primary | Number of Patients With Adverse Drug Reactions (ADRs) | Number of Patients with ADRs. An adverse drug reaction was defined as an adverse event with a relationship to Tiotropium inhalation. | Pre treatment and 52 weeks after the treatment | No |
| Secondary | Effective Rate of Comprehensive Evaluation | Evaluate from improvement FEV1 (forced expiratory volume in 1 second) and/or Symptoms by Investigator. Latest time point, at the end of the observation or 1 year after the initiation of treatment, investigator judged and decided "comprehensive evaluation". "comprehensive evaluation" was classified into 3 category, "improve" "No change+Aggravated" and "Unassessable" by reference to the result of FEV1 and symptoms. The effective rate was derived from rate of "Improvement" in total number of analyzed patients |
52 weeks | No |
| Secondary | Change in Forced Expiratory Volume (L) in 1 Second at 52 Weeks | Difference between Mean of Pre- and each week's forced expiratory volume in 1 second (FEV1) The FEV1 is the volume (Liters) exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity. FEV1 is by far the most frequently used index for assessing airway obstruction, bronchoconstriction or bronchodilatation | Pre treatment and 52 weeks after the treatment | No |
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