Special Drug Use Investigation for ADOAIR DISKUS COPD (Salmeterol and Fluticasone)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01332409
First received: April 7, 2011
Last updated: June 6, 2013
Last verified: June 2013
  Purpose

To investigate possible problems or questions in safety and effectiveness of salmeterol and fluticasone in patients with chronic obstructive pulmonary disease (bronchitis chronic / emphysema). In this special drug use investigation, onset of pneumonia shall be handled as the priority investigation item.


Condition Intervention
Pulmonary Disease, Chronic Obstructive
Drug: Salmeterol and Fluticasone

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Special Drug Use Investigation for ADOAIR DISKUS COPD (Salmeterol and Fluticasone)

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • The incidence of adverse events in Japanese patients treated with salmeterol and fluticasone based on prescribing information under the conditions of general clinical practice. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 2000
Study Start Date: August 2009
Study Completion Date: January 2013
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients prescribed salmeterol and fluticasone
Patients with chronic obstructive pulmonary disease prescribed salmeterol and fluticasone during study period
Drug: Salmeterol and Fluticasone
Administered according to the prescribing information in the locally approved label by the authorities.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients who are diagnosed as having a chronic obstructive pulmonary disease (bronchitis chronic / emphysema)

Criteria

Inclusion Criteria:

  • Must use salmeterol and fluticasone 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: NCT01332409

Locations
Japan
GSK Investigational Site
Chiba, Japan, 296-8602
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01332409     History of Changes
Other Study ID Numbers: 113095
Study First Received: April 7, 2011
Last Updated: June 6, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Lung Diseases, Obstructive
Salmeterol
Fluticasone
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
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 16, 2014