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Special Drug Use Investigation for ADOAIR (Fluticasone/Salmeterol)

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ClinicalTrials.gov Identifier: NCT01395862
Recruitment Status : Completed
First Posted : July 18, 2011
Last Update Posted : August 21, 2013
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Description
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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

Study Design
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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

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Groups and Cohorts
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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


Outcome Measures
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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 ]

Eligibility Criteria
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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.
Criteria

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
Contacts and Locations
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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): NCT01395862


Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
More Information
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01395862     History of Changes
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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Respiration Disorders
Respiratory Tract Diseases
Fluticasone
Salmeterol Xinafoate
Fluticasone-Salmeterol 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
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Sympathomimetics