Special Drug Use Investigation for ADOAIR DISKUS COPD (Salmeterol and Fluticasone)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01332409

Enrollment

2000

Registered

2011-04-11

Start date

2009-08-31

Completion date

2013-01-31

Last updated

2013-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Brief summary

To investigate possible problems or questions in safety and effectiveness of salmeterol and fluticasone in patients with chronic obstructive pulmonary disease (bronchitis chronic / emphysema). In this special drug use investigation, onset of pneumonia shall be handled as the priority investigation item.

Interventions

DRUGSalmeterol and Fluticasone

Administered according to the prescribing information in the locally approved label by the authorities.

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Must use salmeterol and fluticasone for the first time

Exclusion criteria

* Patients with hypersensitivity to salmeterol and fluticasone * Patients with infection which salmeterol and fluticasone is not effective * Patients with deep mycosis

Design outcomes

Primary

Measure	Time frame
The incidence of adverse events in Japanese patients treated with salmeterol and fluticasone based on prescribing information under the conditions of general clinical practice.	1 year

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026