Last updated: 11/07/2018 19:02:03
Influence Of Salmeterol Xinafoate/Fluticasone Propionate (50/500 µg BID) On The Course Of The Disease And Exacerbation Frequency In COPD Patients Gold Stage III And IV
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A 12 month open-label randomized parallel group study to investigate the influence of salmeterol xinafoate/fluticasone propionate 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.
Trial description: 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 Chronic Obstructive Pulmonary Disease (COPD) patients (Global Initiative for Chronic Obstructive Lung Disease (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 50/500 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Mean number of exacerbations per year: negative binomial model
Timeframe: Baseline through Week 52
Mean number of exacerbations per year: Poisson model
Timeframe: Baseline through Week 52
Secondary outcomes:
Compliance and adherence to study medication
Timeframe: Baseline through Week 52
Mean number of COPD-related visits at/by physician
Timeframe: Baseline through Week 52
Number of participants with the indicated number of days at the intensive care unit (ICU)
Timeframe: Baseline through Week 52
Number of participants with the indicated number of hospital stays
Timeframe: Baseline through Week 52
Mean number of days rescue medication was used
Timeframe: The 7 days before baseline (=Visit 2 [Week 8]) and the last 7 days of study (=Visit 6 [Week 52])
Mean change from baseline in forced expiratory volume in 1 second (FEV1) at Week 52
Timeframe: Baseline and Week 52
Mean change from baseline in inspiratory vital capacity (IVC) at Week 52
Timeframe: Baseline and Week 52
Mean change from baseline in the Tiffeaneau Index at Week 52
Timeframe: Baseline and Week 52
Mean change from baseline in the symptom score of the St. George's Respiratory Questionnaire (SGRQ) at Week 52
Timeframe: Baseline and Week 52
Mean change from baseline in the activity score of the St. George's Respiratory Questionnaire (SGRQ) at Week 52
Timeframe: Baseline and Week 52
Mean change from baseline in the impact score of the St. George's Respiratory Questionnaire (SGRQ) at Week 52
Timeframe: Baseline and Week 52
Mean change from baseline in the total score of the St. George's Respiratory Questionnaire (SGRQ) at Week 52
Timeframe: Baseline and Week 52
Mean total costs (related to COPD) per participant
Timeframe: Baseline through Week 52
Interventions:
Drug: Salmeterol / Fluticasone (50/500 µg) BID fixed combination
Drug: Salmeterol / Fluticasone (50/500 µg) BID separate Inhalers
Enrollment:
214
Observational study model:
Not applicable
Primary completion date:
2009-02-07
Time perspective:
Not applicable
Clinical publications:
Hagedorn C, Kaessner F, Banik N, Ntampakas P, Fielder K. Influence Of salmeterol/fluticasone via single versus separate inhalers on exacerbations in severe / very severe COPD. Respir Med. 2013;107(4):542-549.
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
fluticasone propionate, fluticasone propionate/salmeterol, fluticasone propionate/salmeterol/norflurane, norflurane, salmeterol
Collaborators
Not applicable
Study date(s)
November 2007 to July 2009
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
No
- 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.
- 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).
Inclusion and exclusion 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 Forced Expiratory Volume, measured at 1 second (FEV1) <50% of predicted normal and a baseline post- bronchodilator FEV1/Inspiratory Vital Capacity (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 at least 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. This includes vaccines, inhaled short-acting beta-2-agonists as needed, short-acting or long-acting anticholinergics (tiotropium), systemic beta-2-agonists, theophylline, mucolytics, antioxidants, beta-1-agonists (for cardiovascular indication), 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: monoamine oxidase inhibitors and tricyclic antidepressants, and ritonavir (a highly potent cytochrome P450 3A4 inhibitor).
- 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 GlaxoSmithKline (GSK).
- Subject participated in an investigational drug study within 30 days prior to Visit 1
Trial location(s)
Location
GSK Investigational Site
Bochum, Nordrhein-Westfalen, Germany, 44787
Status
Study Complete
Location
GSK Investigational Site
Wiesloch, Baden-Wuerttemberg, Germany, 69168
Status
Study Complete
Location
GSK Investigational Site
Saarbruecken, Saarland, Germany, 66111
Status
Study Complete
Location
GSK Investigational Site
Neuruppin, Brandenburg, Germany, 16816
Status
Study Complete
Location
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30169
Status
Study Complete
Location
GSK Investigational Site
Guetersloh, Nordrhein-Westfalen, Germany, 33330
Status
Study Complete
Location
GSK Investigational Site
Bruchsal, Baden-Wuerttemberg, Germany, 76646
Status
Study Complete
Location
GSK Investigational Site
Heidelberg, Baden-Wuerttemberg, Germany, 69117
Status
Study Complete
Location
GSK Investigational Site
Mannheim, Baden-Wuerttemberg, Germany, 68161
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2009-02-07
Actual study completion date
2009-02-07
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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