NCT01395849

Brief Summary

The purpose of this post-marketing surveillance is to detect adverse drug reactions (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 treated with fluticasone propionate and salmeterol xinafoate.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
2,116

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2007

Typical duration for all trials

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
5 months 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
Last Updated

May 16, 2017

Status Verified

May 1, 2017

Enrollment Period

1.9 years

First QC Date

July 14, 2011

Last Update Submit

May 15, 2017

Conditions

Respiratory Disorders

Outcome Measures

Primary Outcomes (1)

  • The number of incidence of adverse events in Japanese asthma patients treated with fluticasone propionate and salmeterol xinafoate

    6 months

Study Arms (1)

Patients prescribed fluticasone and salmeterol

Patients with asthma prescribed fluticasone and salmeterol during study period

Drug: Salmeterol and Fluticasone

Interventions

Salmeterol and FluticasoneDRUG
Patients prescribed fluticasone and salmeterol

Eligibility Criteria

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

Japanese patients with asthma

You may qualify if:

  • Must use fluticasone and salmeterol for the first time

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
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2011

First Posted

July 18, 2011

Study Start

October 1, 2007

Primary Completion

September 1, 2009

Study Completion

March 1, 2011

Last Updated

May 16, 2017

Record last verified: 2017-05