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Drug Use Investigation for ADOAIR (Fluticasone/Salmeterol)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01395849
First received: July 14, 2011
Last updated: May 15, 2017
Last verified: May 2017
  Purpose
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 Intervention
Respiratory Disorders Drug: Salmeterol and Fluticasone

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Prospective
Official Title: Drug Use Investigation for ADOAIR (Fluticasone/Salmeterol)

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

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

Enrollment: 2116
Study Start Date: October 2007
Study Completion Date: March 2011
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients prescribed fluticasone and salmeterol
Patients with asthma prescribed fluticasone and salmeterol during study period
Drug: Salmeterol and Fluticasone

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01395849

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01395849     History of Changes
Other Study ID Numbers: 112277
Study First Received: July 14, 2011
Last Updated: May 15, 2017

Additional relevant MeSH terms:
Respiration Disorders
Respiratory Tract Diseases
Fluticasone
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
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Sympathomimetics

ClinicalTrials.gov processed this record on July 24, 2017