CClinicalTrials.gg
Sign In
CompletedNCT00527826Updated Oct 30, 2012Results posted

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

A Phase 4 interventional study of Salmeterol / Fluticasone (50/500 µg) BID fixed combination and Salmeterol / Fluticasone (50/500 µg) BID separate Inhalers in Pulmonary Disease, Chronic Obstructive, sponsored by GlaxoSmithKline. Completed at 23 sites in Germany. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2012-10-30.

Sponsored by GlaxoSmithKline · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
214
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study 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.

Read the 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)

02

Conditions studied

  • Pulmonary Disease, Chronic Obstructive

Keywords

  • Severe and very severe COPD (GOLD stage III / IV) exacerbations
  • health care utilisation
  • Chronic Obstructive Pulmonary Disease (COPD)
  • quality of life
  • compliance
  • salmeterol/fluticasone combination
03

In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's enrollment of 214 is above the median of 72 across 2,118 interventional studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
214 participants (actual)

Study arms

  • Active comparator
    arm 1

    Drug: Salmeterol / Fluticasone (50/500 µg) BID fixed combination

  • Active comparator
    arm 2

    Drug: Salmeterol / Fluticasone (50/500 µg) BID separate Inhalers

Interventions

  • DrugSalmeterol / Fluticasone (50/500 µg) BID fixed combination

    comparator

  • DrugSalmeterol / Fluticasone (50/500 µg) BID separate Inhalers

    comparator

06

What researchers measure

Primary outcomes

  1. Mean Number of Exacerbations Per Year: Negative Binomial Model

    During regular visits, participants were asked whether they experienced any exacerbation since last contact. Between visits, COPD participants were contacted by phone by the staff and asked about exacerbation details. Exacerbations were defined according to Rodriguez-Roisin: moderate (grade II) exacerbations include a worsening of COPD symptoms that require both a change of respiratory medication (increased dose of prescribed or addition of new drugs) and medical assistance; severe (grade III) exacerbations include deterioration in COPD resulting in hospitalization or emergency room treatment.

    Time frame: Baseline through Week 52

  2. Mean Number of Exacerbations Per Year: Poisson Model

    During regular visits, participants were asked whether they experienced any exacerbation since last contact. Between visits, COPD participants were contacted by phone by the staff and asked about exacerbation details. Exacerbations were defined according to Rodriguez-Roisin: moderate (grade II) exacerbations include a worsening of COPD symptoms that require both a change of respiratory medication (increased dose of prescribed or addition of new drugs) and medical assistance; severe (grade III) exacerbations include deterioration in COPD resulting in hospitalization or emergency room treatment.

    Time frame: Baseline through Week 52

Secondary outcomes

  1. Compliance and Adherence to Study Medication

    Compliance is calculated as the ratio (in percent) between the number of actual doses taken during the total treatment period divided by the number of doses that should have been taken during the total treatment period.

    Time frame: Baseline through Week 52

  2. Mean Number of COPD-related Visits at/by Physician

    The total number of COPD-related visits, i.e., from baseline through week 52, the number of visits at physician's office, the number of home visits made by physician, the number of visits at an emergency outpatient clinic, as well as the number of home visits by an emergency physician were summed up.

    Time frame: Baseline through Week 52

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

    The number participants with the indicated number of days at the ICU was recorded.

    Time frame: Baseline through Week 52

  4. Number of Participants With the Indicated Number of Hospital Stays

    The number of participants with the indicated number of hospitalizations was recorded.

    Time frame: Baseline through Week 52

  5. Mean Number of Days Rescue Medication Was Used

    Participants were asked for the number of days they used rescue medication within the 7 days before Week 8 and Week 52.

    Time frame: The 7 days before baseline (=Visit 2 [Week 8]) and the last 7 days of study (=Visit 6 [Week 52])

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

    Change from baseline was calculated as the FEV1 percent predicted value at Week 52 minus the percent predicted value at baseline. The post-bronchodilator lung function test was performed to measure FEV1 30 minutes after inhaling salbutamol. The most reliable result of three different consecutive measurements was documented.

    Time frame: Baseline and Week 52

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

    Change from baseline was measured as the IVC value at Week 52 minus the value at baseline. The post-bronchodilator lung function test was performed to measure IVC 30 minutes after inhaling salbutamol. The most reliable result of three different, consecutive measurements was documented.

    Time frame: Baseline and Week 52

  8. Mean Change From Baseline in the Tiffeaneau Index at Week 52

    The Tiffeneau index is defined as the FEV1 divided by the IVC (i.e., forced expiratory volume in one second relative to the inspiratory capacity) in percent. Change from baseline is calculated as the FEV1/IVC value at Week 52 minus the value at baseline.

    Time frame: Baseline and Week 52

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

    Change from baseline is calculated as the symptom score at Week 52 minus the symptom score at baseline. The SGRQ (a self-administered questionnaire) subscale symptom score ranges from 0 to 100% and measures the effect of respiratory symptoms, frequency, and severity on quality of life (summed weights of 8 questions). A score of 0 indicates the best possible status.

    Time frame: Baseline and Week 52

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

    Change from baseline is calculated as the activity score at Week 52 minus the score at baseline. The SGRQ (a self-administered questionnaire) subscale activity score ranges from 0 to 100% and is concerned with activities that cause or are limited by breathlessness (summed weights of 2 questions). A score of 0 indicates the best possible status.

    Time frame: Baseline and Week 52

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

    Change from baseline was calculated as the impact score at Week 52 minus the score at baseline. The SGRQ (a self-administered questionnaire) subscale impact score ranges from 0 to 100% and is concerned with social functioning and psychological disturbances (summed weights of 5 questions). A score of 0 indicates the best possible status.

    Time frame: Baseline and Week 52

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

    Change from baseline was calculated as the total score at Week 52 minus the score at baseline. The SGRQ (a self-administered questionnaire) total score ranges from 0 to 100% and summarizes the impact of COPD on overall health status (summed weights of 15 questions). A total score of 0 indicates the best possible status.

    Time frame: Baseline and Week 52

  13. Mean Total Costs (Related to COPD) Per Participant

    Total costs include costs for hospitalization, medication, and visits to/by physician. Medications that were used "as required" were assumed to be used every second day.

    Time frame: Baseline through Week 52

07

Results

Posted Jun 24, 2010

Participant flow

Participant flow — Overall Study
MilestoneSalmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µgSalmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg
Started108106
Completed8780
Not completed2126
Withdrew: Adverse event1010
Withdrew: Lost to follow-up32
Withdrew: Withdrawal by subject58
Withdrew: Inclusion criteria not met33
Withdrew: Alpha-1 antitrypsin deficiency01
Withdrew: Additional intake of viani forte01
Withdrew: Participant moved away01

Outcome measures

PrimaryMean Number of Exacerbations Per Year: Negative Binomial Model

During regular visits, participants were asked whether they experienced any exacerbation since last contact. Between visits, COPD participants were contacted by phone by the staff and asked about exacerbation details. Exacerbations were defined according to Rodriguez-Roisin: moderate (grade II) exacerbations include a worsening of COPD symptoms that require both a change of respiratory medication (increased dose of prescribed or addition of new drugs) and medical assistance; severe (grade III) exacerbations include deterioration in COPD resulting in hospitalization or emergency room treatment.

Time frame:
Baseline through Week 52
Reported as:
Least squares mean · Number of exacerbations per year
Mean Number of Exacerbations Per Year: Negative Binomial Model
Number of exacerbations per yearSalmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µgSalmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg
Mean Number of Exacerbations Per Year: Negative Binomial Model0.864 ± 0.1340.862 ± 0.138
Statistical analysis
  • Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg vs Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg · Negative binomial model · p = 0.73Least square means adjusted for COPD severity (stratum), interaction of stratum with treatment, and strata imbalance of 73% COPD III vs. 27% COPD IV.
SecondaryCompliance and Adherence to Study Medication

Compliance is calculated as the ratio (in percent) between the number of actual doses taken during the total treatment period divided by the number of doses that should have been taken during the total treatment period.

Time frame:
Baseline through Week 52
Reported as:
Mean · percentage of doses
Compliance and Adherence to Study Medication
percentage of dosesSalmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µgSal 50 µgFP 500 µg
Compliance and Adherence to Study Medication97.08 ± 11.6198.44 ± 19.6298.33 ± 19.36
PrimaryMean Number of Exacerbations Per Year: Poisson Model

During regular visits, participants were asked whether they experienced any exacerbation since last contact. Between visits, COPD participants were contacted by phone by the staff and asked about exacerbation details. Exacerbations were defined according to Rodriguez-Roisin: moderate (grade II) exacerbations include a worsening of COPD symptoms that require both a change of respiratory medication (increased dose of prescribed or addition of new drugs) and medical assistance; severe (grade III) exacerbations include deterioration in COPD resulting in hospitalization or emergency room treatment.

Time frame:
Baseline through Week 52
Reported as:
Least squares mean · Number of exacerbations per year
Mean Number of Exacerbations Per Year: Poisson Model
Number of exacerbations per yearSalmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µgSalmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg
Mean Number of Exacerbations Per Year: Poisson Model0.863 ± 0.1360.830 ± 0.137
Statistical analysis
  • Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg vs Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg · Poisson model · p = 0.66Least square means adjusted for COPD severity (stratum), interaction of stratum with treatment, and strata imbalance of 73% COPD III vs. 27% COPD IV.
SecondaryMean Number of COPD-related Visits at/by Physician

The total number of COPD-related visits, i.e., from baseline through week 52, the number of visits at physician's office, the number of home visits made by physician, the number of visits at an emergency outpatient clinic, as well as the number of home visits by an emergency physician were summed up.

Time frame:
Baseline through Week 52
Reported as:
Mean · number of visits
Mean Number of COPD-related Visits at/by Physician
number of visitsSalmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µgSalmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µgTotal
Mean Number of COPD-related Visits at/by Physician1.39 ± 2.331.06 ± 2.231.23 ± 2.28
SecondaryNumber of Participants With the Indicated Number of Days at the Intensive Care Unit (ICU)

The number participants with the indicated number of days at the ICU was recorded.

Time frame:
Baseline through Week 52
Reported as:
Number · participants
Number of Participants With the Indicated Number of Days at the Intensive Care Unit (ICU)
participantsSalmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µgSalmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µgTotal
0 days191332
1-5 days426
6-10 days112
11-30 days000
>30 days101
SecondaryNumber of Participants With the Indicated Number of Hospital Stays

The number of participants with the indicated number of hospitalizations was recorded.

Time frame:
Baseline through Week 52
Reported as:
Number · participants
Number of Participants With the Indicated Number of Hospital Stays
participantsSalmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µgSalmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µgTotal
0 hospital stays8287169
1 hospital stay111324
2 hospital stays9312
3 hospital stays415
4 hospital stays011
5 or more hospital stays101
SecondaryMean Number of Days Rescue Medication Was Used

Participants were asked for the number of days they used rescue medication within the 7 days before Week 8 and Week 52.

Time frame:
The 7 days before baseline (=Visit 2 [Week 8]) and the last 7 days of study (=Visit 6 [Week 52])
Reported as:
Mean · number of days
Mean Number of Days Rescue Medication Was Used
number of daysSalmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µgSalmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µgTotal
Visit 2 (Week 8)4.73 ± 2.374.11 ± 2.774.43 ± 2.58
Final visit (Week 52)5.03 ± 2.454.69 ± 2.674.86 ± 2.56
SecondaryMean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 52

Change from baseline was calculated as the FEV1 percent predicted value at Week 52 minus the percent predicted value at baseline. The post-bronchodilator lung function test was performed to measure FEV1 30 minutes after inhaling salbutamol. The most reliable result of three different consecutive measurements was documented.

Time frame:
Baseline and Week 52
Reported as:
Mean · percent of predicted value
Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 52
percent of predicted valueSalmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µgSalmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µgTotal
Baseline36.82 ± 8.9338.15 ± 9.2637.47 ± 9.10
Week 5238.98 ± 13.1541.22 ± 15.2640.09 ± 14.24
Mean change from baseline2.17 ± 10.423.08 ± 12.082.62 ± 11.26
SecondaryMean Change From Baseline in Inspiratory Vital Capacity (IVC) at Week 52

Change from baseline was measured as the IVC value at Week 52 minus the value at baseline. The post-bronchodilator lung function test was performed to measure IVC 30 minutes after inhaling salbutamol. The most reliable result of three different, consecutive measurements was documented.

Time frame:
Baseline and Week 52
Reported as:
Mean · liters
Mean Change From Baseline in Inspiratory Vital Capacity (IVC) at Week 52
litersSalmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µgSalmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µgTotal
Baseline2.17 ± 0.742.29 ± 0.712.23 ± 0.72
Week 522.14 ± 0.722.27 ± 0.682.21 ± 0.70
Mean change from baseline-0.02 ± 0.53-0.02 ± 0.50-0.02 ± 0.51
SecondaryMean Change From Baseline in the Tiffeaneau Index at Week 52

The Tiffeneau index is defined as the FEV1 divided by the IVC (i.e., forced expiratory volume in one second relative to the inspiratory capacity) in percent. Change from baseline is calculated as the FEV1/IVC value at Week 52 minus the value at baseline.

Time frame:
Baseline and Week 52
Reported as:
Mean · percent of IVC
Mean Change From Baseline in the Tiffeaneau Index at Week 52
percent of IVCSalmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µgSalmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µgTotal
Baseline48.90 ± 11.0949.05 ± 10.7648.98 ± 10.90
Week 5250.82 ± 10.9852.83 ± 16.3951.81 ± 13.93
Mean change from baseline1.92 ± 8.763.78 ± 13.422.84 ± 11.32
SecondaryMean Change From Baseline in the Symptom Score of the St. George's Respiratory Questionnaire (SGRQ) at Week 52

Change from baseline is calculated as the symptom score at Week 52 minus the symptom score at baseline. The SGRQ (a self-administered questionnaire) subscale symptom score ranges from 0 to 100% and measures the effect of respiratory symptoms, frequency, and severity on quality of life (summed weights of 8 questions). A score of 0 indicates the best possible status.

Time frame:
Baseline and Week 52
Reported as:
Mean · percent
Mean Change From Baseline in the Symptom Score of the St. George's Respiratory Questionnaire (SGRQ) at Week 52
percentSalmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µgSalmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µgTotal
Baseline68.80 ± 19.6568.95 ± 18.3868.88 ± 18.99
Week 5265.42 ± 19.7663.77 ± 19.9464.61 ± 19.82
Mean change from baseline-3.38 ± 17.65-5.18 ± 17.27-4.27 ± 17.44
SecondaryMean Change From Baseline in the Activity Score of the St. George's Respiratory Questionnaire (SGRQ) at Week 52

Change from baseline is calculated as the activity score at Week 52 minus the score at baseline. The SGRQ (a self-administered questionnaire) subscale activity score ranges from 0 to 100% and is concerned with activities that cause or are limited by breathlessness (summed weights of 2 questions). A score of 0 indicates the best possible status.

Time frame:
Baseline and Week 52
Reported as:
Mean · percent
Mean Change From Baseline in the Activity Score of the St. George's Respiratory Questionnaire (SGRQ) at Week 52
percentSalmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µgSalmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µgTotal
Baseline72.80 ± 17.7870.64 ± 17.4571.73 ± 17.61
Week 5271.17 ± 20.2968.53 ± 21.7269.86 ± 21.01
Mean change from baseline-1.63 ± 16.63-2.11 ± 16.53-1.87 ± 16.54
SecondaryMean Change From Baseline in the Impact Score of the St. George's Respiratory Questionnaire (SGRQ) at Week 52

Change from baseline was calculated as the impact score at Week 52 minus the score at baseline. The SGRQ (a self-administered questionnaire) subscale impact score ranges from 0 to 100% and is concerned with social functioning and psychological disturbances (summed weights of 5 questions). A score of 0 indicates the best possible status.

Time frame:
Baseline and Week 52
Reported as:
Mean · percent
Mean Change From Baseline in the Impact Score of the St. George's Respiratory Questionnaire (SGRQ) at Week 52
percentSalmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µgSalmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µgTotal
Baseline46.03 ± 20.3043.58 ± 17.3744.82 ± 18.90
Week 5244.66 ± 21.1541.26 ± 19.5342.98 ± 20.39
Mean change from baseline-1.37 ± 17.52-2.32 ± 17.87-1.84 ± 17.66
SecondaryMean Change From Baseline in the Total Score of the St. George's Respiratory Questionnaire (SGRQ) at Week 52

Change from baseline was calculated as the total score at Week 52 minus the score at baseline. The SGRQ (a self-administered questionnaire) total score ranges from 0 to 100% and summarizes the impact of COPD on overall health status (summed weights of 15 questions). A total score of 0 indicates the best possible status.

Time frame:
Baseline and Week 52
Reported as:
Mean · percent
Mean Change From Baseline in the Total Score of the St. George's Respiratory Questionnaire (SGRQ) at Week 52
percentSalmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µgSalmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µgTotal
Baseline57.82 ± 17.0755.89 ± 15.3656.87 ± 16.24
Week 5256.02 ± 18.2253.25 ± 17.7154.65 ± 17.98
Mean change from baseline-1.80 ± 14.42-2.64 ± 14.73-2.22 ± 14.55
SecondaryMean Total Costs (Related to COPD) Per Participant

Total costs include costs for hospitalization, medication, and visits to/by physician. Medications that were used "as required" were assumed to be used every second day.

Time frame:
Baseline through Week 52
Reported as:
Mean · Euros per participant
Mean Total Costs (Related to COPD) Per Participant
Euros per participantSalmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µgSalmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µgTotal
Mean Total Costs (Related to COPD) Per Participant1453 ± 24271166 ± 15341311 ± 2034

Adverse events

Collected over Adverse events (AE) and serious adverse events (SAEs) were collected after the start of the study (visit 1, Week 0) until the last visit (visit 6, Week 52).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg—23/108 (21.3%)45/108 (41.7%)
Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg—16/105 (15.2%)48/105 (45.7%)
Most frequent serious events
Showing 10 of 38
Most frequent serious events
EventSalmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µgSalmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg
Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders12/1087/105
PneumoniaInfections and infestations3/1084/105
Infective exacerbation of chronic obstructive airways diseaseInfections and infestations2/1081/105
ArrhythmiaCardiac disorders0/1081/105
Atrial fibrillationCardiac disorders0/1081/105
Cardiac failureCardiac disorders1/1081/105
CyanosisCardiac disorders0/1081/105
Gastric ulcerGastrointestinal disorders0/1081/105
Gastrointestinal haemorrhageGastrointestinal disorders0/1081/105
Intestinal haemorrhageGastrointestinal disorders0/1081/105
Most frequent other events
Most frequent other events
EventSalmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µgSalmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg
Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders33/10833/105
Infective exacerbation of chronic obstructive airways diseaseInfections and infestations12/10816/105
NasopharyngitisInfections and infestations3/1088/105
PneumoniaInfections and infestations7/1085/105
DyspnoeaRespiratory, thoracic and mediastinal disorders4/1086/105

Baseline characteristics

Age Continuous
Age Continuous(years)Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µgSalmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µgTotal
Mean65.6 ± 8.364.2 ± 8.964.9 ± 8.6
Sex: Female, Male
Sex: Female, Male(Participants)Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µgSalmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µgTotal
Female332962
Male7476150
Severity of Chronic Obstructive Lung Disease (COPD)
Severity of Chronic Obstructive Lung Disease (COPD)(participants)Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µgSalmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µgTotal
Severe COPD7779156
Very severe COPD302656
Smoking History
Smoking History(participants)Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µgSalmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µgTotal
Ex-smoker7478152
Smoker332760
08

Study locations

23 sites
  • 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
  • GSK Investigational Site
    Berlin, 10365, Germany
  • GSK Investigational Site
    Berlin, 13187, Germany
  • GSK Investigational Site
    Hamburg, 22299, Germany
09

References and documents

Publications

  • Hagedorn C, Kassner 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 Apr;107(4):542-9. doi: 10.1016/j.rmed.2012.12.020. Epub 2013 Jan 20. PubMed 23337300 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 30, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00527826
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Sep 11, 2007
Start date
Nov 2007
Primary completion
Jul 2009
Completion
Jul 2009
Results posted
Jun 24, 2010
Last update
Oct 30, 2012

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Lung Diseases→

Other studies from this sponsor

GlaxoSmithKline

Start the discussion