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Special Drug Use Investigation for ADOAIR DISKUS COPD

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01332409
First received: April 7, 2011
Last updated: January 24, 2013
Last verified: January 2013
History of Changes
  Purpose

To investigate possible problems or questions in safety and efficacy of ADOAIR 250 DISKUS (hereinafter referred to as "ADOAIR") 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • The incidence of adverse events in Japanese patients treated with ADOAIR based on prescribing information under the conditions of general clinical practice. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 2000
Study Start Date: August 2009
Estimated Study Completion Date: April 2013
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients prescribed ADOAIR
Patients with chronic obstructive pulmonary disease prescribed ADOAIR during study period
 Drug: Salmeterol and Fluticasone

  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 ADOAIR 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: January 24, 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 May 16, 2013