Influence Of Salmeterol/Fluticasone (50/500BD)On The Course Of The Disease And Exacerbation Frequency In COPD Patients Gold Stage III And IV
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: COPD
Intervention: Salmeterol / Fluticasone (50/500mcg ) BD fixed combination (Drug); Salmeterol / Fluticasone (50/500mcg ) BD separate Inhalers (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, Prof.Dr.med., Study Director, Affiliation: GlaxoSmithKline
Summary
This is a 12 month randomized, open-label, parallel-group study to obtain data on the
frequency and variability of exacerbations in severe and very severe COPD patients (GOLD
Stage III and IV) receiving salmeterol xinafoate and fluticasone propionate either in fixed
combination (SFC) or from separate inhalers (Sal/FP) with standard therapy. 200 subjects will
be enrolled in approximately 30 study centres in Germany. Data on health care utilisation
will be collected to compare direct costs associated with COPD in these two groups.
Baseline data will be collected for all subjects at Visit 1 and eligible subjects will be
randomized to receive either SFC 500/50 µg bid (twice daily) as fixed combination or Sal 50
µg bid (twice daily) and FP 500 µg bid (twice daily) concurrently over 52 weeks. Subjects
will return for study visits every two to three months until week 52. Additional telephone
calls will be made between scheduled visits every 4 weeks. Assessments will include
monitoring of frequency of exacerbations, health care utilisation (including emergency
visits and hospitalizations) and rescue medication, lung function, drug compliance,
health-related quality of life (SGRQ = St George's Respiratory Questionnaire) and safety.
Clinical Details
Official title: A 12 Month Open-Label Randomized Parallel Group Study to Investigate the Influence of Salmeterol/Fluticasone (50/500 BD) Either in Fixed Combination or Separately Via Diskus Inhalers on the Course of the Disease and Frequency of Exacerbations in Subjects With Severe and Very Severe COPD ( GOLD Stage III+IV)
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
Primary outcome: The primary endpoint measure is the frequency of exacerbations (Grade II and III according to Rodriguez-Roisin) during the treatment period of 52 weeks
Secondary outcome: Secondary endpoints will be compliance and adherence to study medication and health care utilisation (visits to study site or GP, emergency room use, hospital stays, drug use, use of supplemental oxygen).
Eligibility
Minimum age: 40 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion criteria:
- Subject must have a diagnosis of COPD based on the American Thoracic Society (ATS)/
European Respiratory Society (ERS) criteria.
- Male or female subjects, aged ? 40 years. Females must be of Non Child Bearing
Potential. The definition of Non Child Bearing Potential is as following: Females,
regardless of their age, with functioning ovaries and who have a current documented
tubal ligation or hysterectomy, or females who are post-menopausal.
- Have diagnosed COPD stage III or IV according to GOLD criteria: a baseline
post-bronchodilator FEV1 < 50% of predicted normal and a baseline post- bronchodilator
FEV1/IVC ratio < 70%.
- Have experienced at least 2 moderate or severe COPD exacerbations leading to medical
consultation (requiring oral corticosteroids or increasing dosage of oral
corticosteroids and/or antibiotics or hospitalization) within the 12 months preceding
Visit 1.
- Have stable COPD medication within 4 weeks prior to Visit 1 (no new medication added
and no dosage changes in medication).
- Current or ex-smokers with a smoking history of ? 10 pack years (number of pack years
= [number of cigarettes per day / 20] x number of years smoked, e. g., 20 cigarettes
per day for 10 years, or 10 cigarettes per day for 20 years).
- Are currently managed at home (outpatients), are ambulatory and able to travel to the
clinic. Subjects can be treated with all relevant COPD medication (refer to Section
5. 6 for details on allowed concomitant medication) including long-acting
anticholinergics (Tiotropiumbromide), non-invasive ventilation, long term oxygen
therapy and can have Cor Pulmonale.
- A signed and dated written informed consent is obtained prior to participation.
- Able to comply with the requirements of the protocol and be available for study visits
over 52 weeks.
Exclusion criteria:
- Known other respiratory disorders or signs for other respiratory disorders (e. g.
asthma, lung cancer, sarcoidosis, tuberculosis, lung fibrosis, cystic fibrosis,
bronchoectasis).
- Known history of significant inflammatory disease, other than COPD (e. g. rheumatoid
arthritis and systemic lupus erythematosus).
- Known to be severely alpha-1-antitrypsin deficient (PI SZ or ZZ)
- Having undergone lung surgery (e. g. lung resection including lung volume reduction
surgery, lung transplant) or subjects scheduled for surgery.
- Concurrent medication from Visit 1 and for the duration of the study with any of the
prohibited medications listed in Section 5. 6.2
- Subjects receiving chronic or prophylactic antibiotic therapy.
- Serious, uncontrolled disease (including serious psychological disorders) likely to
interfere with the study or impact on subject safety.
- Have, in the opinion of the investigator, evidence of alcohol, drug or solvent abuse.
- History of depression.
- History or presence of clinically significant drug sensitivity or clinically
significant allergic reaction to corticosteroids or salmeterol.
- Moderate or severe COPD exacerbation (requiring corticosteroids or increased dosage of
corticosteroids and/or antibiotics or hospitalization) within the 4 weeks prior to
Visit 1
- Lower respiratory tract infection within the 4 weeks prior to Visit 1 .
- Pregnant or lactating female and female of childbearing potential.
- Subject is a participating investigator, sub-investigator, study coordinator, or other
employee of a participating investigator, or is an immediate family member of the
before mentioned. Subject is an employee of GSK.
- Subject participated in an investigational drug study within 30 days prior to Visit 1
Locations and Contacts
GSK Clinical Trials Call Center, Potsdam 14469, Germany; Not yet recruiting
GSK Clinical Trial Call Center, Phone: 1-877-379-3718, Email: klaus.ams@gsk.com
GSK Clinical Trials Call Center, Cottbus 03050, Germany; Not yet recruiting
GSK Clinical Trial Call Center, Phone: 1-877-379-3718, Email: klaus.ams@gsk.com
GSK Clinical Trials Call Center, Bruchsal 76646, Germany; Not yet recruiting
GSK Clinical Trial Call Center, Phone: 1-877-379-3718, Email: klaus.ams@gsk.com
GSK Clinical Trials Call Center, Wiesbaden 65183, Germany; Not yet recruiting
GSK Clinical Trial Call Center, Phone: 1-877-379-3718, Email: klaus.ams@gsk.com
GSK Clinical Trials Call Center, Bochum 44787, Germany; Not yet recruiting
GSK Clinical Trial Call Center, Phone: 1-877-379-3718, Email: klaus.ams@gsk.com
GSK Clinical Trials Call Center, Mannheim 68161, Germany; Not yet recruiting
GSK Clinical Trial Call Center, Phone: 1-877-379-3718, Email: klaus.ams@gsk.com
GSK Clinical Trials Call Center, Heidelberg 69117, Germany; Not yet recruiting
GSK Clinical Trial Call Center, Phone: 1-877-379-3718, Email: klaus.ams@gsk.com
GSK Clinical Trials Call Center, Kassel 34117, Germany; Not yet recruiting
GSK Clinical Trial Call Center, Phone: 1-877-379-3718, Email: klaus.ams@gsk.com
GSK Clinical Trials Call Center, Eschwege 37296, Germany; Not yet recruiting
GSK Clinical Trial Call Center, Phone: 1-877-379-3718, Email: klaus.ams@gsk.com
GSK Clinical Trials Call Center, Kaufbeuren 34121, Germany; Not yet recruiting
GSK Clinical Trial Call Center, Phone: 1-877-379-3718, Email: klaus.ams@gsk.com
GSK Clinical Trials Call Center, Gelnhausen 63571, Germany; Not yet recruiting
GSK Clinical Trial Call Center, Phone: 1-877-379-3718, Email: klaus.ams@gsk.com
GSK Clinical Trials Call Center, Wiesloch 69168, Germany; Not yet recruiting
GSK Clinical Trial Call Center, Phone: 1-877-379-3718, Email: klaus.ams@gsk.com
GSK Clinical Trials Call Center, Marburg 35037, Germany; Not yet recruiting
GSK Clinical Trial Call Center, Phone: 1-877-379-3718, Email: klaus.ams@gsk.com
GSK Clinical Trials Call Center, Hamburg 22299, Germany; Not yet recruiting
GSK Clinical Trial Call Center, Phone: 1-877-379-3718, Email: klaus.ams@gsk.com
GSK Clinical Trials Call Center, Hannover 30169, Germany; Not yet recruiting
GSK Clinical Trial Call Center, Phone: 1-877-379-3718, Email: klaus.ams@gsk.com
GSK Clinical Trials Call Center, Saarbrucken 66111, Germany; Not yet recruiting
GSK Clinical Trial Call Center, Phone: 1-877-379-3718, Email: klaus.ams@gsk.com
GSK Clinical Trials Call Center, Annaberg-Buchholz 09456, Germany; Not yet recruiting
GSK Clinical Trial Call Center, Phone: 1-877-379-3718, Email: klaus.ams@gsk.com
GSK Clinical Trials Call Center, Berlin 13187, Germany; Not yet recruiting
GSK Clinical Trial Call Center, Phone: 1-877-379-3718, Email: klaus.ams@gsk.com
GSK Clinical Trials Call Center, Berlin 10365, Germany; Not yet recruiting
GSK Clinical Trial Call Center, Phone: 1-877-379-3718, Email: klaus.ams@gsk.com
GSK Clinical Trials Call Center, Schmolln 04626, Germany; Not yet recruiting
GSK Clinical Trial Call Center, Phone: 1-877-379-3718, Email: klaus.ams@gsk.com
GSK Clinical Trials Call Center, Gutersloh 33330, Germany; Not yet recruiting
GSK Clinical Trial Call Center, Phone: 1-877-379-3718, Email: klaus.ams@gsk.com
GSK Clinical Trials Call Center, Radebeul 01445, Germany; Not yet recruiting
GSK Clinical Trial Call Center, Phone: 1-877-379-3718, Email: klaus.ams@gsk.com
GSK Clinical Trials Call Center, Leipzig 04275, Germany; Not yet recruiting
GSK Clinical Trial Call Center, Phone: 1-877-379-3718, Email: klaus.ams@gsk.com
GSK Clinical Trials Call Center, Erfurt 99084, Germany; Not yet recruiting
GSK Clinical Trial Call Center, Phone: 1-877-379-3718, Email: klaus.ams@gsk.com
Additional Information
Starting date: November 2007
Ending date: June 2009
Last updated: April 4, 2008
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