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Pulmonary Disease, Chronic ObstructivePhase 4NCT00527826

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 study testing Salmeterol / Fluticasone (50/500 µg) BID fixed combination and Salmeterol / Fluticasone (50/500 µg) BID separate Inhalers in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 23 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Pulmonary Disease, Chronic Obstructive
What is being tested?
Salmeterol / Fluticasone (50/500 µg) BID fixed combination and Salmeterol / Fluticasone (50/500 µg) BID separate Inhalers
Could I receive a placebo?
No, everyone receives an active treatment
How many people
214 participants
Where
23 sitesGermany
Study dates
Nov 2007to Jul 2009
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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.

Who cannot join

  • 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.
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  • 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 locations and contacts

23 sites in 1 country.

23 sites in 1 country

Germany23 sites

  • GSK Investigational Site

    Annaberg, Saxony, 09456

  • GSK Investigational Site

    Berlin, State of Berlin, 10365

  • GSK Investigational Site

    Berlin, State of Berlin, 13187

  • GSK Investigational Site

    Bochum, North Rhine-Westphalia, 44787

  • GSK Investigational Site

    Bruchsal, Baden-Wurttemberg, 76646

  • GSK Investigational Site

    Cottbus, Brandenburg, 03050

  • GSK Investigational Site

    Eschwege, Hesse, 37269

  • GSK Investigational Site

    Gelnhausen, Hesse, 63571

  • GSK Investigational Site

    Gütersloh, North Rhine-Westphalia, 33330

  • GSK Investigational Site

    Hamburg, Free and Hanseatic City of Hamburg, 22299

  • GSK Investigational Site

    Hanover, Lower Saxony, 30169

  • GSK Investigational Site

    Heidelberg, Baden-Wurttemberg, 69117

  • GSK Investigational Site

    Kassel, Hesse, 34121

  • GSK Investigational Site

    Leipzig, Saxony, 04275

  • GSK Investigational Site

    Mannheim, Baden-Wurttemberg, 68161

  • GSK Investigational Site

    Marburg, Hesse, 35037

  • GSK Investigational Site

    Neuruppin, Brandenburg, 16816

  • GSK Investigational Site

    Potsdam, Brandenburg, 14469

  • GSK Investigational Site

    Radebeul, Saxony, 01445

  • GSK Investigational Site

    Saarbrücken, Saarland, 66111

  • GSK Investigational Site

    Schmölln, Thuringia, 04626

  • GSK Investigational Site

    Wiesbaden, Hesse, 65183

  • GSK Investigational Site

    Wiesloch, Baden-Wurttemberg, 69168

Other trials in Germany

About this study

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.

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)

Being tested
Salmeterol / Fluticasone (50/500 µg) BID fixed combination, Salmeterol / Fluticasone (50/500 µg) BID separate Inhalers
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
Medical subject headings
Pulmonary Disease, Chronic Obstructive, Patient Compliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Salmeterol / Fluticasone (50/500 µg) BID fixed combinationDrug

    comparator

  • Salmeterol / Fluticasone (50/500 µg) BID separate InhalersDrug

    comparator

Study groups in NCT00527826
Study groupRoleWhat they receive
arm 1Active comparatorNot described
Receives: Drug: Salmeterol / Fluticasone (50/500 µg) BID fixed combination
arm 2Active comparatorNot described
Receives: Drug: Salmeterol / Fluticasone (50/500 µg) BID separate Inhalers

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: Baseline through Week 52

Secondary outcomes (13)

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Baseline through Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2007 (estimated)
  2. Study startNov 2007
  3. Primary completionJul 2009
  4. Study completionJul 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
214 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00527826
Sponsor's protocol ID
SCO107227
Status last verified
Oct 2012
First submitted
10 Sep 2007
Last updated
30 Oct 2012

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Salmeterol / Fluticasone (50/500 µg) BID fixed combination and Salmeterol / Fluticasone (50/500 µg) BID separate Inhalers in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 23 sites in Germany.

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 9 inclusion and 15 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 30 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jun 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Mean Number of Exacerbations Per Year: Negative Binomial Model (time frame: Baseline through Week 52). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00527826, which also lists 1 linked publication.

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 30 Oct 2012.

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