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

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.

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

GSK Investigational Site

Chiba, 296-8602, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Salmeterol and Fluticasone

Drug

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

Primary outcomes

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

Time frame: 1 year

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Important dates

Study start: 2009
Primary completion: 2012
Study completion: 2013
First posted: Apr 11, 2011
Registry last updated: Jun 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed