Clinical trial NCT01749462: Oxis 9mcg Turbuhaler Clinical Experience Investigation
Official title: Oxis 9mcg Turbuhaler Clinical Experience Investigation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: chronic obstructive pulmonary disease,
COPD,
Oxis,
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2012-12-13
Enrollment: 398
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with Oxis for the first time due to 'relief of various symptoms associated with airway obstructive disorders of chronic obstructive pulmonary disease (Chronic bronchitis, Pulmonary emphysema), which is the indication of this drug.

Brief summary: The purpose of the investigation is to confirm the ADR development and the contributing factors possibly having an impact on the safety under the post-marketing actual use of Oxis 9 mcg Turbuhaler.

Detailed description: Oxis 9mcg Turbuhaler Clinical Experience Investigation

Eligibility criteria: Inclusion Criteria:

- Patients treated with Oxis for the first time due to 'relief of various symptoms associated with airway obstructive disorders of chronic obstructive pulmonary disease (Chronic bronchitis, Pulmonary emphysema), which is the indication of this drug.

Primary outcomes:
measure: Adverse event incidence
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: Research Site
state: D5127l00001
city: Akita
country: Japan
facility: Research Site
state: D5127l00001
city: Aomori
country: Japan
facility: Research Site
state: D5127l00001
city: Chiba
country: Japan
facility: Research Site
state: D5127l00001
city: Fukuoka
country: Japan
facility: Research Site
state: D5127l00001
city: Fukushima
country: Japan
facility: Research Site
state: D5127l00001
city: Gifu
country: Japan
facility: Research Site
state: D5127l00001
city: Gunma
country: Japan
facility: Research Site
state: D5127l00001
city: Hiroshima
country: Japan
facility: Research Site
state: D5127l00001
city: Hokkaido
country: Japan
facility: Research Site
state: D5127l00001
city: Hyogo
country: Japan
facility: Research Site
state: D5127l00001
city: Ibaraki
country: Japan
facility: Research Site
state: D5127l00001
city: Ishikawa
country: Japan
facility: Research Site
state: D5127l00001
city: Iwate
country: Japan
facility: Research Site
state: D5127l00001
city: Kagawa
country: Japan
facility: Research Site
state: D5127l00001
city: Kagoshima
country: Japan
facility: Research Site
state: D5127l00001
city: Kanagawa
country: Japan
facility: Research Site
state: D5127l00001
city: Kochi
country: Japan
facility: Research Site
state: D5127l00001
city: Kyoto
country: Japan
facility: Research Site
state: D5127l00001
city: Mie
country: Japan
facility: Research Site
state: D5127l00001
city: Miyagi
country: Japan
facility: Research Site
state: D5127l00001
city: Miyazaki
country: Japan
facility: Research Site
state: D5127l00001
city: Nagano
country: Japan
facility: Research Site
state: D5127l00001
city: Nagasaki
country: Japan
facility: Research Site
state: D5127l00001
city: Nara
country: Japan
facility: Research Site
state: D5127l00001
city: Niigata
country: Japan
facility: Research Site
state: D5127l00001
city: Oita
country: Japan
facility: Research Site
state: D5127l00001
city: Okayama
country: Japan
facility: Research Site
state: D5127l00001
city: Okinawa
country: Japan
facility: Research Site
state: D5127l00001
city: Osaka
country: Japan
facility: Research Site
state: D5127l00001
city: Saitama
country: Japan
facility: Research Site
state: D5127l00001
city: Shiga
country: Japan
facility: Research Site
state: D5127l00001
city: Shimane
country: Japan
facility: Research Site
state: D5127l00001
city: Shizuoka
country: Japan
facility: Research Site
state: D5127l00001
city: Tochigi
country: Japan
facility: Research Site
state: D5127l00001
city: Tokushima
country: Japan
facility: Research Site
state: D5127l00001
city: Tokyo
country: Japan
facility: Research Site
state: D5127l00001
city: Toyama
country: Japan
facility: Research Site
state: D5127l00001
city: Yamagata
country: Japan
facility: Research Site
state: D5127l00001
city: Yamaguchi
country: Japan
facility: Research Site
state: D5127l00001
city: Yamanashi
country: Japan
facility: Research Site
state: D5127l00001
Study officials:
affiliation: Astrazeneca KK
name: Shigeru Yoshida, MD
role: STUDY_DIRECTOR
References: