Clinical trial NCT00638183: Special Survey Long-term Treatment With Tiotropium on COPD
Official title: Special Survey Long-term Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2008-03-18
Enrollment: 385
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: COHORT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Patients With Adverse Events (AEs)
timeFrame: Pre treatment and 52 weeks after the treatment
measure: Number of Patients With Adverse Drug Reactions (ADRs)
timeFrame: Pre treatment and 52 weeks after the treatment
Secondary outcomes:
measure: Effective Rate of Comprehensive Evaluation
timeFrame: 52 weeks
measure: Change in Forced Expiratory Volume (L) in 1 Second at 52 Weeks
timeFrame: Pre treatment and 52 weeks after the treatment
Other outcomes:
Locations:
city: Asahikawa
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Chikushino
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Daito
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Ebina
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Echizen
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Fukui
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Fukushima
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Funabashi
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Gosen
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Habikino
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Hakodate
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Hayashimacho
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Higashiosakaka
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Himeji
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Hirosaki
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Hiroshima
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Hitachi
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Iizuka
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Ikoma
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Ishinomaki
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Itanocho
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Kasukabe
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Katsuragicho
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Kawasaki
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Kishiwada
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Kitakyushu
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Kobayashi
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Koga
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Komaki
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Komatsu
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Koshu
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Kumamoto
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Kunimicho
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Kyotango
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Kyoto
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Matsudo
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Matsue
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Matsumoto
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Mihamacho
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Minamiuonuma
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Mishima
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Mizumakimachi
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Morioka
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Nagaoka
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Nagasaki
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Nagoya
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Nichinan
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Niihama
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Nogata
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Numata
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Obihiro
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Obu
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Odawara
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Ogaki
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Okuchi
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Osaka
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Otsu
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Saiki
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Saitama
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Sakai
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Sakede
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Sapporo
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Sayama
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Sendai
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Shiroishicho
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Shiroishi
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Shizuoka
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Tagawa
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Takarazuka
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Tokyo Chiyoda-ku
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Tokyo Higashiyamato
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Tokyo Itabashi-ku
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Tokyo Kita-ku
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Tokyo Koto-ku
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Tokyo Meguro-ku
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Tokyo Otaku-ku
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Tokyo Shinjuku-ku
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Tsukuba
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Tsu
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Ube
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Uji
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Urayasu
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Uruma
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Utsunomiya
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Yamagata
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Yame
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Yokohama
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Yorocho
country: Japan
facility: Boehringer Ingelheim Investigational Site
city: Yurihonjo
country: Japan
facility: Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: