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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00662805
First received: April 14, 2008
Last updated: January 16, 2014
Last verified: January 2014

April 14, 2008
January 16, 2014
June 2004
September 2008   (final data collection date for primary outcome measure)
The change in markers of increased cardiovascular risk (e.g proinflammatory and prothrombotic markers, microalbuminuria) [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
Evaluate adverse events, vital sign reporting, and concomitant medications
Not Provided
Complete list of historical versions of study NCT00662805 on ClinicalTrials.gov Archive Site
  • Trough FEV1, FVC and FEV1/ FVC ratio [ Time Frame: every 26 weeks ] [ Designated as safety issue: No ]
  • Health status as determined using the St George's Respiratory Questionnaire (SGRQ) [ Time Frame: every 26 weeks ] [ Designated as safety issue: No ]
  • Laboratory assessment including levels of appropriate cardiovascular markers (e.g. CRP, Fibrinogen, PAI-1) and established risk factors, as well as detection of microalbuminuria [ Time Frame: every 26 weeks ] [ Designated as safety issue: No ]
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Not Provided
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Pharmacovigilance Study to Evaluate Safety of SERETIDE in Participants With Chronic Obstructive Pulmonary Disease (COPD)
A 2-year Observational Study to Evaluate Safety of Seretide 50/500μg Twice Daily Administered by DISKUS, in Patients With COPD

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.

Not Provided
Observational
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Participants will undergo physical examination and blood pressure measurement. A complete medical history will be taken, as well as blood and urine samples.

Non-Probability Sample

Planned: 1000 / Recruited: 771 / Analyzed: 771 A target enrolment of approximately 1000 subjects is planned, at outpatient sites. Any subject with COPD who has an indication to receive Salmeterol + Fluticasone 50/500mcg twice daily at the discretion of the investigator and has met all the inclusion criteria, may take part in the study.

Inclusion criteria

  • Outpatient diagnosed with COPD (Criteria of the British Thoracic Society or NHLBI/WHO Global initiative for Chronic Obstructive Lung Disease)
  • FEV1 < 50% of the one predicted at treatment start and/or
  • History of repetitive COPD exacerbations and/or
  • Patient remains symptomatic despite regular bronchodilator therapy
Pulmonary Disease, Chronic Obstructive
Drug: Salmeterol/Fluticasone propionate
Open label, of Salmeterol/Fluticasone propionate (50/500 μg) twice daily via dry powder inhaler (DPI)
Salmeterol/Fluticasone propionate (50/500 μg)
Open label, 6 visits, single arm study
Intervention: Drug: Salmeterol/Fluticasone propionate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
762
September 2008
September 2008   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00662805
104246, Seretide-pv/GR
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP