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Drug Use Investigation for ADOAIR (Fluticasone/Salmeterol)

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01395849
First received: July 14, 2011
Last updated: NA
Last verified: June 2011
History: No changes posted
  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: Time Perspective: Prospective
Official Title: Drug Use Investigation for ADOAIR (Fluticasone/Salmeterol)

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01395849

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

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01395849     History of Changes
Other Study ID Numbers: 112277
Study First Received: July 14, 2011
Last Updated: July 14, 2011
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Respiration Disorders
Respiratory Tract Diseases
Salmeterol
Albuterol
Fluticasone
Fluticasone, salmeterol drug combination
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
 Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Tocolytic Agents
Reproductive Control Agents
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Sympathomimetics

ClinicalTrials.gov processed this record on May 16, 2013