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

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01332409
• Collaborator: (none)
• Enrollment: 2,000
• Location: 1
• Duration (Months): 41
• Patients Per Site Per Month: 48.7

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Pulmonary Disease, Chronic Obstructive	Drug: Salmeterol and Fluticasone

Study Design

• Study Type: Observational
• Actual Enrollment: 2000 participants
• Time Perspective: Prospective
• Official Title: Special Drug Use Investigation for ADOAIR DISKUS COPD (Salmeterol and Fluticasone)
• Study Start Date: Aug 1, 2009
• Actual Primary Completion Date: Apr 1, 2012
• Actual Study Completion Date: Jan 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. The incidence of adverse events in Japanese patients treated with salmeterol and fluticasone based on prescribing information under the conditions of general clinical practice. [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Chiba		Japan	296-8602

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

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
• Other Study ID Numbers: 113095
• First Posted: Apr 11, 2011
• Last Update Posted: Jun 10, 2013
• Last Verified: Jun 1, 2013

• Additional relevant MeSH terms: Pulmonary Disease, Chronic Obstructive; Fluticasone; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination

Study Results

No Results Posted as of Jun 10, 2013