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Drug Use Investigation for ADOAIR (Fluticasone/Salmeterol)

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ClinicalTrials.gov Identifier: NCT01395849
Recruitment Status : Completed
First Posted : July 18, 2011
Last Update Posted : May 16, 2017
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Respiratory Disorders Drug: Salmeterol and Fluticasone

Study Type : Observational
Actual Enrollment : 2116 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Drug Use Investigation for ADOAIR (Fluticasone/Salmeterol)
Study Start Date : October 2007
Primary Completion Date : September 2009
Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Patients prescribed fluticasone and salmeterol
Patients with asthma prescribed fluticasone and salmeterol during study period
Drug: Salmeterol and Fluticasone

Primary Outcome Measures :
  1. The number of incidence of adverse events in Japanese asthma patients treated with fluticasone propionate and salmeterol xinafoate [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Japanese patients with asthma

Inclusion Criteria:

  • Must use fluticasone and salmeterol 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01395849

Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01395849     History of Changes
Other Study ID Numbers: 112277
First Posted: July 18, 2011    Key Record Dates
Last Update Posted: May 16, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Respiration Disorders
Respiratory Tract Diseases
Salmeterol Xinafoate
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists