Clinical trial NCT00620516: Tiotropium 18ug Inhalation Capsule Using a Handihaler® Among Korean COPD Patients
Official title: Regulatory Requisite Post Marketing Surveillance to Assess the Safety and Efficacy of Spiriva® HandiHaler® (Tiotropium Bromide Inhalation Powder 18mcg, q.d.) in Korean COPD Patients: A 30-Day, Open Label, Non-interventional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2008-02-21
Enrollment: 3008
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 3227

Brief summary: This is a descriptive observational open non-comparative study of the safety and efficacy of tiotropium inhalation capsule given at 18mcg once a day for 30 days among Korean patients with COPD. At Visit 1, patients who are diagnosed as COPD will be prescribed tiotropium inhalation capsule at 18mcg once daily (at the same time). Patients' FEV1 will be assessed before start of treatment (Visit 1) and at the end of the 30 day treatment period (Visit 2). Occurrence of adverse events will also be asked from the patient at the end of the 30 day treatment period. Patients will be informed by the attending physicians to immediately report the occurrence of serious adverse events.

Detailed description: Study Design:

Eligibility criteria: Inclusion Criteria:

Older than 40 years old Diagnosed as COPD No Previous Spiriva administration No Contraindication for Spiriva according to the product label

Exclusion Criteria:

patients with history of hypersensitivity to atropine and its derivatives (e.g. ipratropium oxitropium or any component of this product).

Primary outcomes:
measure: The primary endpoint for this postmarking study is the occurrence of adverse events, anytime during the 30 day study period, which might or might not be connected with the use of Spiriva® 18 mcg inhalation capsule
timeFrame: 30 days
Secondary outcomes:
measure: Secondary endpoints include change in post bronchodilator FEV1 and assessment of any change in overall severity of the disease from baseline to the end of 30 day treatment.
timeFrame: 30 days
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 1
city: Busan
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 2
city: Busan
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 3
city: Busan
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 4
city: Chugnam
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 5
city: Chugnam
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 6
city: Chugnam
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 7
city: Chungbuk
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 69
city: Daegu
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 10
city: Daegu
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 11
city: Daegu
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 12
city: Daegu
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 13
city: Daegu
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 8
city: Daegu
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 9
city: Daejeon
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 14
city: Daejeon
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 15
city: Daejeon
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 16
city: Daejeon
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 17
city: Daejeon
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 18
city: Daejeon
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 19
city: Gangwondo
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 20
city: Gangwondo
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 21
city: Gangwondo
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 22
city: Gangwondo
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 23
city: Gyeonggido
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 24
city: Gyeonggido
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 25
city: Gyeonggido
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 26
city: Gyeonggido
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 27
city: Gyeonggido
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 28
city: Gyeonggido
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 29
city: Gyeonggido
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 30
city: Gyeonggido
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 31
city: Gyeonggido
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 32
city: Gyeongnam
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 70
city: Gyeongnam
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 71
city: Incheon
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 33
city: Incheon
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 34
city: Incheon
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 35
city: Incheon
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 36
city: Jeonbuk
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 37
city: Jeonbuk
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 38
city: Jeonbuk
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 39
city: Jeonnam
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 40
city: Jeonnam
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 41
city: Jeonnam
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 42
city: Jeonnam
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 43
city: Jeonnam
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 44
city: Jeonnam
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 45
city: Jeonnam
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 46
city: Seoul
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 47
city: Seoul
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 48
city: Seoul
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 49
city: Seoul
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 50
city: Seoul
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 51
city: Seoul
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 52
city: Seoul
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 53
city: Seoul
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 54
city: Seoul
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 55
city: Seoul
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 56
city: Seoul
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 57
city: Seoul
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 58
city: Seoul
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 59
city: Seoul
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 60
city: Seoul
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 61
city: Seoul
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 62
city: Seoul
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 63
city: Seoul
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 64
city: Seoul
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 65
city: Seoul
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 66
city: Seoul
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 67
city: Ulsan
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site 68
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: