Special Drug Use Investigation for ADOAIR (Fluticasone/Salmeterol)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01395862
First received: July 14, 2011
Last updated: August 20, 2013
Last verified: August 2013
  Purpose

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 Intervention
Respiratory Disorders
Drug: Salmeterol and Fluticasone

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Special 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 and salmeterol for long-term [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 1001
Study Start Date: November 2007
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients prescribed fluticasone and salmeterol
Patients with asthma prescribed fluticasone and salmeterol for long-term use during study period
Drug: Salmeterol and Fluticasone

  Eligibility

Genders Eligible for Study:   Both
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
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: NCT01395862

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

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01395862     History of Changes
Other Study ID Numbers: 112278
Study First Received: July 14, 2011
Last Updated: August 20, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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

ClinicalTrials.gov processed this record on August 21, 2014