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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

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pulmonary Disease, Chronic Obstructive

Intervention: Salmeterol / Fluticasone (50/500 µg) BID fixed combination (Drug); Salmeterol / Fluticasone (50/500 µg) BID separate Inhalers (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, 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 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.

Clinical Details

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.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Mean Number of Exacerbations Per Year: Negative Binomial Model

Mean Number of Exacerbations Per Year: Poisson Model

Secondary outcome:

Compliance and Adherence to Study Medication

Mean Number of COPD-related Visits at/by Physician

Number of Participants With the Indicated Number of Days at the Intensive Care Unit (ICU)

Number of Participants With the Indicated Number of Hospital Stays

Mean Number of Days Rescue Medication Was Used

Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 52

Mean Change From Baseline in Inspiratory Vital Capacity (IVC) at Week 52

Mean Change From Baseline in the Tiffeaneau Index at Week 52

Mean Change From Baseline in the Symptom Score of the St. George's Respiratory Questionnaire (SGRQ) at Week 52

Mean Change From Baseline in the Activity Score of the St. George's Respiratory Questionnaire (SGRQ) at Week 52

Mean Change From Baseline in the Impact Score of the St. George's Respiratory Questionnaire (SGRQ) at Week 52

Mean Change From Baseline in the Total Score of the St. George's Respiratory Questionnaire (SGRQ) at Week 52

Mean Total Costs (Related to COPD) Per Participant

Detailed description: A 12 month open-label randomized parallel group study to investigate the influence of salmeterol xinafoate/fluticasone propionate either in fixed combination (SFC50/500 µg bid) or separately (SAL 50 µg and FP 500 µg bid) 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)

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 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

Locations and Contacts

GSK Investigational Site, Berlin 10365, Germany

GSK Investigational Site, Berlin 13187, Germany

GSK Investigational Site, Hamburg 22299, Germany

GSK Investigational Site, Bruchsal, Baden-Wuerttemberg 76646, Germany

GSK Investigational Site, Heidelberg, Baden-Wuerttemberg 69117, Germany

GSK Investigational Site, Mannheim, Baden-Wuerttemberg 68161, Germany

GSK Investigational Site, Wiesloch, Baden-Wuerttemberg 69168, Germany

GSK Investigational Site, Cottbus, Brandenburg 03050, Germany

GSK Investigational Site, Neuruppin, Brandenburg 16816, Germany

GSK Investigational Site, Potsdam, Brandenburg 14469, Germany

GSK Investigational Site, Eschwege, Hessen 37269, Germany

GSK Investigational Site, Gelnhausen, Hessen 63571, Germany

GSK Investigational Site, Kassel, Hessen 34121, Germany

GSK Investigational Site, Marburg, Hessen 35037, Germany

GSK Investigational Site, Wiesbaden, Hessen 65183, Germany

GSK Investigational Site, Hannover, Niedersachsen 30169, Germany

GSK Investigational Site, Bochum, Nordrhein-Westfalen 44787, Germany

GSK Investigational Site, Guetersloh, Nordrhein-Westfalen 33330, Germany

GSK Investigational Site, Saarbruecken, Saarland 66111, Germany

GSK Investigational Site, Annaberg, Sachsen 09456, Germany

GSK Investigational Site, Leipzig, Sachsen 04275, Germany

GSK Investigational Site, Radebeul, Sachsen 01445, Germany

GSK Investigational Site, Schmoelln, Thueringen 04626, Germany

Additional Information

Starting date: November 2007
Last updated: October 25, 2012

Page last updated: August 23, 2015

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