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CompletedNCT01395849Updated May 16, 2017

Drug Use Investigation for ADOAIR (Fluticasone/Salmeterol)

An observational study in Respiratory Disorders, sponsored by GlaxoSmithKline. Completed. Per ClinicalTrials.gov, last updated 2017-05-16.

Sponsored by GlaxoSmithKline · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
2,116
Sex
All
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Study 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.

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Conditions studied

  • Respiratory Disorders
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In context

Respiration Disorders

513 studies on the registry are indexed under Respiration Disorders; 98 are open to participants now.

This study's enrollment of 2,116 is above the median of 239 across 207 observational studies indexed under Respiration Disorders.

Browse Respiration Disorders studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Sampling method
Probability sample

Study population

Japanese patients with asthma

Inclusion criteria

  • Must use fluticasone and salmeterol for the first time

Exclusion criteria

Exclusion Criteria:

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

Observational model
Other
Time perspective
Prospective
Enrollment
2,116 participants (actual)

Groups and cohorts

  • Patients prescribed fluticasone and salmeterol

    Patients with asthma prescribed fluticasone and salmeterol during study period

    Drug: Salmeterol and Fluticasone

Interventions

  • DrugSalmeterol and Fluticasone
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What researchers measure

Primary outcomes

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

    Time frame: 6 months

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01395849
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Jul 18, 2011
Start date
Oct 2007
Primary completion
Sep 2009
Completion
Mar 2011
Last update
May 16, 2017

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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