Pharmacovigilance Study to Evaluate Safety of SERETIDE in Participants With Chronic Obstructive Pulmonary Disease (COPD)

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

762 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-06-30

Study Completion Date

2008-09-30

Brief Summary

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Primary objective: Evaluation of the safety of Seretide discus administration in subjects with COPD. Treatment duration: 2 years. Study has 3 phases: Screening phase (visit 1), treatment phase (visits 2-5. In the case of AE, there will be another visit (visit 6) as a follow up visit - follow up phase.

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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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Salmeterol/Fluticasone propionate (50/500 μg)

Open label, 6 visits, single arm study

Salmeterol/Fluticasone propionate

Intervention Type DRUG

Open label, of Salmeterol/Fluticasone propionate (50/500 μg) twice daily via dry powder inhaler (DPI)

Interventions

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Salmeterol/Fluticasone propionate

Open label, of Salmeterol/Fluticasone propionate (50/500 μg) twice daily via dry powder inhaler (DPI)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subject should fulfill criteria for the subscription of SERETIDE as these are mentioned in SPC.

Exclusion Criteria

* Hypersensitivity to Salmeterol + Fluticasone or any of its excipients
* Pregnancy, lactation or scheduled pregnancy during the observational period of the study
* Serious illness/disease, not adequately controlled, or with a potential to interfere with the patients' participation in the present study, according to the investigator/physician's judgment.

Eligible Sex

ALL

Accepts Healthy Volunteers

No