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:


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
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

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

ClinicalTrials.gov processed this record on October 23, 2014