Status:

COMPLETED

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

Lead Sponsor:

GlaxoSmithKline

Conditions:

Pulmonary Disease, Chronic Obstructive

Eligibility:

All Genders

Brief Summary

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...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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.

Key Trial Info

Start Date :

June 1 2004

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

September 1 2008

Estimated Enrollment :

762 Patients enrolled

Trial Details

Trial ID

NCT00662805

Start Date

June 1 2004

End Date

September 1 2008

Last Update

January 20 2014

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