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Trial record 4 of 321 for:    FLUTICASONE AND SALMETEROL

Special Drug Use Investigation for ADOAIR (Fluticasone/Salmeterol)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01395862
Recruitment Status : Completed
First Posted : July 18, 2011
Last Update Posted : August 21, 2013
Information provided by (Responsible Party):

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.

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

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Study Type : Observational
Actual Enrollment : 1001 participants
Time Perspective: Prospective
Official Title: Special Drug Use Investigation for ADOAIR (Fluticasone/Salmeterol)
Study Start Date : November 2007
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Patients prescribed fluticasone and salmeterol
Patients with asthma prescribed fluticasone and salmeterol for long-term use 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 and salmeterol for long-term [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Japanese patients with asthma who are expected to use fluticasone and salmeterol for long-term.

Inclusion Criteria:

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

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 identifier (NCT number): NCT01395862

Sponsors and Collaborators
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Study Director: GSK Clinical Trials GlaxoSmithKline

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Responsible Party: GlaxoSmithKline Identifier: NCT01395862    
Other Study ID Numbers: 112278
First Posted: July 18, 2011    Key Record Dates
Last Update Posted: August 21, 2013
Last Verified: August 2013
Additional relevant MeSH terms:
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Salmeterol Xinafoate
Fluticasone-Salmeterol Drug Combination
Respiration Disorders
Respiratory Tract Diseases
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