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

NCT ID: NCT01332409

Last Updated: 2013-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-08-31

Study Completion Date

2013-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Patients prescribed salmeterol and fluticasone

Patients with chronic obstructive pulmonary disease prescribed salmeterol and fluticasone during study period

Salmeterol and Fluticasone

Intervention Type DRUG

Administered according to the prescribing information in the locally approved label by the authorities.

Interventions

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Salmeterol and Fluticasone

Administered according to the prescribing information in the locally approved label by the authorities.

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Chiba, , Japan

Site Status

Countries

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Japan

References

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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.

Reference Type BACKGROUND

Other Identifiers

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113095

Identifier Type: -

Identifier Source: org_study_id

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