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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

Ages Eligible for Study:   Child, Adult, Senior
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
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: NCT01332409

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

Publications:
Yoriko Morioka, Hiroharu Abe, Terufumi Hara, Pascal Yoshida. Post-marketing Surveillance of Salmeterol Xinafoate / Fluticasone Propionate (Adoair®250Diskus®) - Interim Report -. Resp Med - Kokyuki Naika. 2013;23(1):111-122.

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:
Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive
Salmeterol Xinafoate
Fluticasone
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Sympathomimetics

ClinicalTrials.gov processed this record on September 30, 2016