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

June 6, 2013 updated by: GlaxoSmithKline
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Chiba, Japan, 296-8602
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients who are diagnosed as having a chronic obstructive pulmonary disease (bronchitis chronic / emphysema)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients prescribed salmeterol and fluticasone
Patients with chronic obstructive pulmonary disease prescribed salmeterol and fluticasone during study period
Drug: Salmeterol and Fluticasone
Administered according to the prescribing information in the locally approved label by the authorities.

What is the study measuring?

Primary Outcome Measures

Outcome 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.
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Yoriko Morioka, Hiroharu Abe, Terufumi Hara, Pascal Yoshida. Post-marketing Surveillance of Salmeterol Xinafoate / Fluticasone Propionate (Adoair®250Diskus®) - Interim Report -. Resp Med - Kokyuki Naika. 2013;23(1):111-122.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

April 7, 2011

First Submitted That Met QC Criteria

April 7, 2011

First Posted (Estimate)

April 11, 2011

Study Record Updates

Last Update Posted (Estimate)

June 10, 2013

Last Update Submitted That Met QC Criteria

June 6, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 113095

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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