Pulmonary Disease, Chronic ObstructiveNCT00662805
Pharmacovigilance Study to Evaluate Safety of SERETIDE in Participants With Chronic Obstructive Pulmonary Disease (COPD)
An observational study of Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline.
Trial 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 2-5. In the case of AE, there will be another visit (visit 6) as a follow up visit - follow up phase. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Salmeterol/Fluticasone propionate
- How many people
- 762 participants
- Where
- No sites listed yet
- Study dates
- Jun 2004to Sep 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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
Who may be able to join
- Subject should fulfill criteria for the subscription of SERETIDE as these are mentioned in SPC.
Who cannot join
- 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.
About this study
Official title: 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.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Salmeterol/Fluticasone propionate
- Keywords
- pharmacovigilance, COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salmeterol/Fluticasone propionateDrug
Open label, of Salmeterol/Fluticasone propionate (50/500 μg) twice daily via dry powder inhaler (DPI)
| Study group | Role | What they receive |
|---|---|---|
| Salmeterol/Fluticasone propionate (50/500 μg) | Open label, 6 visits, single arm study Receives: Drug: Salmeterol/Fluticasone propionate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in markers of increased cardiovascular risk (e.g proinflammatory and prothrombotic markers, microalbuminuria)
Evaluate adverse events, vital sign reporting, and concomitant medications
Measured: 104 weeks
Secondary outcomes (3)
Trough FEV1, FVC and FEV1/ FVC ratio
Measured: every 26 weeks
Health status as determined using the St George's Respiratory Questionnaire (SGRQ)
Measured: every 26 weeks
Laboratory assessment including levels of appropriate cardiovascular markers (e.g. CRP, Fibrinogen, PAI-1) and established risk factors, as well as detection of microalbuminuria
Measured: every 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2008 (estimated)
- Study startJun 2004
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 762 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00662805
- Sponsor's protocol ID
- 104246
- Other IDs
- Seretide-pv/GR
- Status last verified
- Jan 2014
- First submitted
- 14 Apr 2008
- Last updated
- 20 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 2-year Observational Study to Evaluate Safety of Seretide 50/500μg Twice Daily Administered by DISKUS, in Patients With COPD
- ClinicalTrials.gov ID
- NCT00662805
- Acronym / sponsor ID
- 104246
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- pharmacovigilance, COPD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 762 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jun 2004
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 21 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Salmeterol/Fluticasone propionate (50/500 μg) | – | Drug: Salmeterol/Fluticasone propionateOpen label, 6 visits, single arm study |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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
Key inclusion criteria (1 listed)
- Subject should fulfill criteria for the subscription of SERETIDE as these are mentioned in SPC.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Salmeterol/Fluticasone propionateOpen label, of Salmeterol/Fluticasone propionate (50/500 μg) twice daily via dry powder inhaler (DPI) | Drug | Salmeterol/Fluticasone propionate (50/500 μg) |
Primary outcome
The change in markers of increased cardiovascular risk (e.g proinflammatory and prothrombotic markers, microalbuminuria)
Time frame: 104 weeks
Evaluate adverse events, vital sign reporting, and concomitant medications
3 secondary outcomes
Trough FEV1, FVC and FEV1/ FVC ratio
Time frame: every 26 weeks
Health status as determined using the St George's Respiratory Questionnaire (SGRQ)
Time frame: every 26 weeks
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in markers of increased cardiovascular risk (e.g proinflammatory and prothrombotic markers, microalbuminuria) (time frame: 104 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2014.