NCT01395862

Brief Summary

The purpose of this study is to detect adverse drug reactions for long-term use (particularly clinically significant adverse drug reactions) occurring in clinical settings, to examine factors likely to affect the safety and efficacy in the Japanese asthma patients who are treated with fluticasone propionate/salmeterol xinafoate.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,001

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2007

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

July 14, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 18, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

August 21, 2013

Status Verified

August 1, 2013

Enrollment Period

4.8 years

First QC Date

July 14, 2011

Last Update Submit

August 20, 2013

Conditions

Respiratory Disorders

Outcome Measures

Primary Outcomes (1)

  • The number of incidence of adverse events in Japanese asthma patients treated with fluticasone and salmeterol for long-term

    1 year

Study Arms (1)

Patients prescribed fluticasone and salmeterol

Patients with asthma prescribed fluticasone and salmeterol for long-term use during study period

Drug: Salmeterol and Fluticasone

Interventions

Salmeterol and FluticasoneDRUG
Patients prescribed fluticasone and salmeterol

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Japanese patients with asthma who are expected to use fluticasone and salmeterol for long-term.

You may qualify if:

  • Must use fluticasone and salmeterol for the first time
  • Must use fluticasone and salmeterol for long-term

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Respiration Disorders

Interventions

Fluticasone-Salmeterol Drug Combination

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Salmeterol XinafoateAlbuterolEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPhenethylaminesEthylaminesFluticasoneAndrostadienesAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsDrug CombinationsPharmaceutical Preparations

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2011

First Posted

July 18, 2011

Study Start

November 1, 2007

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

August 21, 2013

Record last verified: 2013-08