Pulmonary Disease, Chronic ObstructivePhase 4NCT01957150
Study Evaluating the Effect of Fluticasone Furoate/ Vilanterol (FF/VI) Inhalation Powder Compared With Vilanterol (VI) Inhalation Powder on Bone Mineral Density (BMD) in Subjects With Chronic Obstructive Pulmonary Disease (COPD).
A Phase 4 study testing Fluticasone Furoate/Vilanterol and Vilanterol in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 45 sites in 5 countries.
Trial summary
This is a multi-center, randomized, double-blind, parallel-group study. The FF/VI inhalation powder once daily and VI inhalation powder once daily will be evaluated in subjects with COPD over 156 weeks. 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?
- Fluticasone Furoate/Vilanterol and Vilanterol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 283 participants
- Where
- 45 sitesin 5 countries
- Study dates
- 28 Jan 2014to 26 Mar 2018
- 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
- Informed consent: Subjects must give their signed and dated written informed consent to participate.
- Gender: Male or female subjects. Female subjects must be post-menopausal or using a highly effective method for avoidance of pregnancy. The decision to include or exclude women of childbearing potential may be made at the discretion of the investigator in accordance with local practice in relation to adequate contraception.
- Age: >= 40 years of age at Screening (Visit 1)
- COPD diagnosis: Subjects with a clinical history of COPD in accordance with the following definition by the American Thoracic Society/European Respiratory Society: COPD is a preventable and treatable disease characterized by airflow limitation that is not fully reversible. The airflow limitation is usually progressive and is associated with an abnormal inflammatory response of the lungs to noxious particles or gases, primarily caused by cigarette smoking. Although COPD affects the lungs, it also produces significant systemic consequences.
- Tobacco use: Subjects with a current or prior history of >=10 pack-years of cigarette smoking at screening (Visit 1). Former smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1. Number of pack years = (number of cigarettes per day/20) x number of years smoked Note: Pipe and/or cigar use cannot be used to calculate pack year history.
- Severity of Disease: Subject with a measured post-albuterol/salbutamol Forced expiratory volume (FEV1)/forced vital capacity (FVC) ratio of <0.70 at Screening (Visit 1). Subjects with a measured post-albuterol/salbutamol 50% <=FEV1 <=70% of predicted normal values calculated using National Health and Nutrition Examination Survey (NHANES III) reference equations at Screening (Visit 1).
- Native Hip: Have at least one evaluable native hip.
Who cannot join
- Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study.
- Asthma: Subjects with a current diagnosis of asthma. (Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD).
- Alpha1-antitrypsin deficiency: Subjects with alpha-1 antitrypsin deficiency as the underlying cause of COPD.
- Other respiratory disorders: Subjects with tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases.
- Lung resection or transplantation: Subjects with lung volume reduction surgery within the 12 months prior to Screening Visit 1 or having had a lung transplant.
- Chest X-ray: Subjects with a chest X-ray (or Computer Axial Tomography (CT) scan) that revealed evidence of clinically significant abnormalities not believed to be due to the presence of COPD. A chest X-ray should be taken at Screening Visit 1 if a chest X-ray or CT scan is not available within 12 months prior to Visit 1.
Show all 32Show fewer
- Poorly controlled COPD: Subjects with poorly controlled COPD, defined as the occurrence of the following in the 12 weeks prior to Screening Visit 1: Acute worsening of COPD that is managed by the subject with corticosteroids or antibiotics or that requires treatment prescribed by a physician or requires hospitalization.
- Moderate or severe COPD exacerbation or lower respiratory tract infection: Subjects with 2 or more moderate or severe COPD exacerbations and/or a lower respiratory tract infection (including pneumonia) within the 12 months prior to Screening Visit 1 or experience a moderate or severe COPD exacerbation and/or a lower respiratory infection (including pneumonia) during the Run-In period. NOTE: A moderate COPD exacerbation is defined as requiring systemic corticosteroids and/or antibiotics. A severe COPD exacerbation is defined as requiring hospitalization.
- Abnormal clinically significant laboratory finding: Subjects who have an abnormal, clinically significant finding in any liver chemistry, biochemical, or haematology tests at Screening Visit 1 or upon repeat prior to randomization.
- Abnormal and clinically significant 12-lead Electrocardiogram (ECG): Subjects who have an abnormal, clinically significant ECG finding at Screening Visit 1.
- Non-Compliance during Run-In Period: Failure to demonstrate adequate compliance with run-in medication (< 80% compliant), the ability to withhold COPD medications, and to keep clinic visit appointments.
- Bone disorders/conditions: Subjects with historical or current evidence of bone cancer, severe scoliosis, rheumatoid arthritis, metabolic bone diseases (other than osteoporosis) including hyper-or hypo-parathyroidism, Paget's disease of bone, osteomalacia, or osteogenesis imperfecta. Removal of vertebrae between L1 and L4 of the lumbar spine and/or presence of metal implants or devices, such as plates, rods, or screws in the lumbar spine and/or hip.
- Immobility: Wheel chair bound or paraplegic.
- Low vitamin D: Previously known low-serum 25-hydroxy vitamin D concentration (less than 10ng [25nmoles] per liter).
- Other diseases/abnormalities: Serious, uncontrolled disease (including serious psychological disorders) likely to interfere with the study within the 3-year study.
- Cancer: Subjects with carcinoma that has not been in complete remission for at least 5 years. Carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded if the subject has been considered cured within 5 years since diagnosis.
- Drug/food allergy: Subjects with a history of hypersensitivity to any of the study medications (e.g. beta-agonists, corticosteroid) or components of the inhalation powder (e.g. lactose, magnesium stearate). In addition, patients with a history of severe milk protein allergy that, in the opinion of the study physician, contraindicates the subject's participation will also be excluded.
- Drug/alcohol abuse: Subjects with a known or suspected history of alcohol or drug abuse within the last 2 years.
- Prohibited medications prior to spirometry at Visit 1: Subjects who are medically unable to withhold the following medications prior to spirometry testing at Visit 1
- No use within 48 hours (hrs) prior to Visit 1 Spirometry Testing: Inhaled corticosteroids, Inhaled Inhaled Corticosteroids (ICS)/ long acting beta2-agonist (LABA) combination products, Long-acting anticholinergics (e.g., tiotropium), Theophylline preparations, Oral leukotriene inhibitors (zafirlukast, montelukast, zileuton), Oral PDE-4 inhibitors (e.g. roflumilast), Oral beta-agonists (Long-acting), Inhaled long acting beta2-agonist (LABA)-Indacaterol.
- No use within 24 hrs prior to Visit 1 Spirometry Testing: Other inhaled LABAs (e.g., salmeterol), Inhaled sodium cromoglycate or nedocromil sodium.
- No use within 12 hrs prior to Visit 1 Spirometry Testing: Oral beta-agonists (Short-acting).
- No use within 4 hrs prior to Visit 1 Spirometry Testing: Ipratropium/ albuterol (salbutamol) combination product, Inhaled short-acting beta2-agonists, Short-acting anti-cholinergics (e.g., ipratropium bromide).
- Additional medication: Use of the following medications within the following time intervals prior to Visit 1 or during the study (unless otherwise specified):
- No use within 12 weeks prior to Screening Visit 1 or thereafter at any time during the study (unless otherwise specified): Depot corticosteroids.
- No use within 30 days prior to Screening Visit 1 or thereafter at any time during the study (unless otherwise specified): Systemic, Oral, parenteral, intra-articular corticosteroids (Subjects may take courses of systemic corticosteroids, where necessary, for treatment of an exacerbation during the double-blind treatment period).
- No use within 30 days or 5 half lives whichever is longer prior to Screening Visit 1 or thereafter at any time during the study (unless otherwise specified): Any other investigational drug.
- COPD medications: Use of ICS, long-acting beta2-agonists (LABA), or ICS/LABA combination products (other than the study-provided double-blind study medication) at Visit 2 (Randomization) or during the double-blind treatment period.
- Oxygen therapy: Subjects receiving treatment with long-term oxygen therapy (LTOT) or nocturnal oxygen therapy required for greater than 12 hours a day. Oxygen prn use (i.e., <=12 hours per day) is not exclusionary.
- Non-compliance: Subjects at risk of non-compliance, or unable to comply with the study procedures. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits.
- Questionable validity of consent: Subjects with a history of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study.
- Affiliation with investigator site: Study investigators, sub-investigators, study coordinators, employees of a participating investigator or immediate family members of the aforementioned are excluded from participating in this study.
Trial locations and contacts
45 sites in 5 countries.
45 sites in 5 countries
United States17 sites
GSK Investigational Site
Bellevue, Nebraska, 68123-4303
GSK Investigational Site
Charleston, South Carolina, 29406-7108
GSK Investigational Site
Chattanooga, Tennessee, 37404
GSK Investigational Site
Erie, Pennsylvania, 16508
GSK Investigational Site
Fort Lauderdale, Florida, 33316
GSK Investigational Site
Jasper, Alabama, 35501
GSK Investigational Site
Knoxville, Tennessee, 37919
GSK Investigational Site
Lawrenceville, Georgia, 30046
GSK Investigational Site
Medford, Oregon, 97504
GSK Investigational Site
Minneapolis, Minnesota, 55402
GSK Investigational Site
Old Point Station, South Carolina, 29707
GSK Investigational Site
Phoenix, Arizona, 85006
GSK Investigational Site
Plymouth, Minnesota, 55441
GSK Investigational Site
San Antonio, Texas, 78229
GSK Investigational Site
Spartanburg, South Carolina, 29303
GSK Investigational Site
Spokane Valley, Washington, 99216
GSK Investigational Site
Wilmington, North Carolina, 28401
Netherlands8 sites
GSK Investigational Site
Alkmaar, 1815 JD
GSK Investigational Site
Beek, 6191 JW
GSK Investigational Site
Ede, 6716 RP
GSK Investigational Site
Eindhoven, 5623 EJ
GSK Investigational Site
Hengelo, 7555 DL
GSK Investigational Site
Hoorn, 1624 NP
GSK Investigational Site
Losser, 7581 BV
GSK Investigational Site
Voerendaal, 6367 TM
Spain8 sites
GSK Investigational Site
Alicante, 03004
GSK Investigational Site
Barcelona, Catalonia, 08017
GSK Investigational Site
Barcelona, 08025
GSK Investigational Site
L'Hospitalet de Llobregat, 08907
GSK Investigational Site
Mérida (Badajoz), 06800
GSK Investigational Site
Ponferrada (León), 24411
GSK Investigational Site
Pozuelo de Alarcón/Madrid, 28223
GSK Investigational Site
Salamanca, 37007
Germany7 sites
GSK Investigational Site
Berlin, 10787
GSK Investigational Site
Berlin, 12157
GSK Investigational Site
Cologne, North Rhine-Westphalia, 51069
GSK Investigational Site
Frankfurt am Main, Hesse, 60596
GSK Investigational Site
Hamburg, 22143
GSK Investigational Site
Koblenz, Rhineland-Palatinate, 56068
GSK Investigational Site
Neu-Isenburg, Hesse, 63263
Canada5 sites
GSK Investigational Site
Québec, Quebec, G1V 4G5
GSK Investigational Site
Saint-Charles-Borromée, Quebec, J6E 2B4
GSK Investigational Site
Sherwood Park, Alberta, T8H 0N2
GSK Investigational Site
Toronto, Ontario, M5T 3A9
GSK Investigational Site
Winnipeg, Manitoba, R2H 2A6
About this study
Official title: Multi-centre, Randomized, Double-blind, Parallel-group Study Evaluating the Effect of Fluticasone Furoate/ Vilanterol (FF/VI) Inhalation Powder Once Daily Compared With Vilanterol (VI) Inhalation Powder Once Daily on Bone Mineral Density (BMD) in Subjects With Chronic Obstructive Pulmonary Disease (COPD).
This is a multi-center, randomized, double-blind, parallel-group study. The FF/VI inhalation powder once daily and VI inhalation powder once daily will be evaluated in subjects with COPD over 156 weeks. The primary objective of this study is to evaluate the effect of the inhaled corticosteroid FF on bone mineral density assessed at the total hip by comparing FF/VI treatment with VI treatment in subjects with moderate COPD.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Fluticasone Furoate/Vilanterol, Vilanterol
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluticasone Furoate/VilanterolDrug
Dry white powder containing 100 mcg of Fluticasone Furoate blended with lactose per blister was administered by NDPI. Dry white powder containing 25 mcg of Vilanterol micronised drug (as the 'M' salt triphenylacetate) blended with lactose and magnesium stearate per blister was administered by NDPI.
VilanterolDrug
Dry white powder containing 25 mcg of Vilanterol micronised drug (as the 'M' salt triphenylacetate) blended with lactose and magnesium stearate per blister was administered by NDPI.
| Study group | Role | What they receive |
|---|---|---|
| Fluticasone Furoate/Vilanterol 100/25 micrograms (mcg) QD | Experimental | Subjects will self administer FF/VI 100/25 mcg inhalation powder once daily for 156 weeks via the NDPI. Receives: Drug: Fluticasone Furoate/Vilanterol |
| Vilanterol 25 mcg QD | Experimental | Subjects will self administer VI 25 mcg inhalation powder once daily for 156 weeks via the NDPI. Receives: Drug: Vilanterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change From Baseline in Bone Mineral Density (BMD) Measured at Total Hip
BMD analysis performed on log (BMD ratio to baseline) using a repeated measures model with covariates of treatment group, age, gender, baseline BMI, visit, log baseline BMD, log baseline BMD by visit and treatment group by visit interactions. These estimates were then converted into annual changes and averaged to calculate the overall treatment estimates and difference which were used for testing non-inferiority. The analysis shown is for the "While on Treatment" estimand of the difference in percentage change from baseline per annum between FF/VI ± BMD medication/SCS (systemic corticosteroids) and VI ± BMD medication/SCS. Baseline is defined as the measurement performed at Visit 1. Percentage change is calculated as (BMD value post-Baseline divided by Baseline value) -1 multiplied by 100.
Measured: Baseline (Visit 1) and 26, 52, 78, 104, 130 and 156 Weeks
Secondary outcomes (5)
Percentage Change From Baseline in BMD Measurements at Total Hip by Gender (Male Participants)
BMD analysis performed on log (BMD ratio to baseline) using separate repeated measures models for each gender with covariates of treatment group, age, baseline BMI, visit, log baseline BMD, log baseline BMD by visit and treatment group by visit interactions. These estimates were then converted into annual changes and averaged to calculate the overall treatment estimates and difference which were used for testing non-inferiority. The analysis shown is for the "While on Treatment" estimand of the difference in percentage change from baseline per annum between FF/VI ± BMD medication/SCS (systemic corticosteroids) and VI ± BMD medication/SCS. Baseline is defined as the measurement performed at Visit 1. Percentage change is calculated as (BMD value post-Baseline divided by Baseline value) -1 multiplied by 100.
Measured: Baseline (Visit 1) and 26, 52, 78, 104, 130 and 156 Weeks
Percentage Change From Baseline in BMD Measurements at Total Hip by Gender (Female Participants)
BMD analysis performed on log (BMD ratio to baseline) using separate repeated measures models for each gender with covariates of treatment group, age, baseline BMI, visit, log baseline BMD, log baseline BMD by visit and treatment group by visit interactions. These estimates were then converted into annual changes and averaged to calculate the overall treatment estimates and difference which were used for testing non-inferiority. The analysis shown is for the "While on Treatment" estimand of the difference in percentage change from baseline per annum between FF/VI ± BMD medication/SCS (systemic corticosteroids) and VI ± BMD medication/SCS. Baseline is defined as the measurement performed at Visit 1. Percentage change is calculated as (BMD value post-Baseline divided by Baseline value) -1 multiplied by 100.
Measured: Baseline (Visit 1) and 26, 52, 78, 104, 130 and 156 Weeks
Percentage Change From Baseline in BMD Measurements at Lumbar Spine (L1 to L4) by Gender (Male Participants)
BMD analysis performed on log (BMD ratio to baseline) using separate repeated measures models for each gender with covariates of treatment group, age, baseline BMI, visit, log baseline BMD, log baseline BMD by visit and treatment group by visit interactions. These estimates were then converted into annual changes and averaged to calculate the overall treatment estimates and difference which were used for testing non-inferiority. The analysis shown is for the "While on Treatment" estimand of the difference in percentage change from baseline per annum between FF/VI ± BMD medication/SCS (systemic corticosteroids) and VI ± BMD medication/SCS. Baseline is defined as the measurement performed at Visit 1. Percentage change is calculated as (BMD value post-Baseline divided by Baseline value) -1 multiplied by 100.
Measured: Baseline (Visit 1) and 26, 52, 78, 104, 130 and 156 Weeks
Percentage Change From Baseline in BMD Measurements at Lumbar Spine (L1 to L4) by Gender (Female Participants)
BMD analysis performed on log (BMD ratio to baseline) using separate repeated measures models for each gender with covariates of treatment group, age, baseline BMI, visit, log baseline BMD, log baseline BMD by visit and treatment group by visit interactions. These estimates were then converted into annual changes and averaged to calculate the overall treatment estimates and difference which were used for testing non-inferiority. The analysis shown is for the "While on Treatment" estimand of the difference in percentage change from baseline per annum between FF/VI ± BMD medication/SCS (systemic corticosteroids) and VI ± BMD medication/SCS. Baseline is defined as the measurement performed at Visit 1. Percentage change is calculated as (BMD value post-Baseline divided by Baseline value) -1 multiplied by 100.
Measured: Baseline (Visit 1) and 26, 52, 78, 104, 130 and 156 Weeks
Percentage Change From Baseline in BMD Measurements at Lumbar Spine (L1 to L4)
BMD analysis performed on log (BMD ratio to baseline) using a repeated measures model with covariates of treatment group, age, gender, baseline BMI, visit, log baseline BMD, log baseline BMD by visit and treatment group by visit interactions. These estimates were then converted into annual changes and averaged to calculate the overall treatment estimates and difference which were used for testing non-inferiority. The analysis shown is for the "While on Treatment" estimand of the difference in percentage change from baseline per annum between FF/VI ± BMD medication/SCS (systemic corticosteroids) and VI ± BMD medication/SCS. Baseline is defined as the measurement performed at Visit 1. Percentage change is calculated as (BMD value post-Baseline divided by Baseline value) -1 multiplied by 100.
Measured: Baseline (Visit 1) and 26, 52, 78, 104, 130 and 156 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study start28 Jan 2014
- Primary completion26 Mar 2018
- Study completion26 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 283 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01957150
- Sponsor's protocol ID
- 102972
- Other IDs
- 2012-004801-28
- Status last verified
- Mar 2019
- First submitted
- 4 Oct 2013
- Last updated
- 10 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-centre, Randomized, Double-blind, Parallel-group Study Evaluating the Effect of Fluticasone Furoate/ Vilanterol (FF/VI) Inhalation Powder Once Daily Compared With Vilanterol (VI) Inhalation Powder Once Daily on Bone Mineral Density (BMD) in Subjects With Chronic Obstructive Pulmonary Disease (COPD).
- ClinicalTrials.gov ID
- NCT01957150
- Acronym / sponsor ID
- 102972
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 283 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 28 Jan 2014 (actual)
- Primary completion
- 26 Mar 2018 (actual)
- Study completion
- 26 Mar 2018 (actual)
- First posted
- 8 Oct 2013 (estimated)
- Results
- Posted 10 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-center, randomized, double-blind, parallel-group study. The FF/VI inhalation powder once daily and VI inhalation powder once daily will be evaluated in subjects with COPD over 156 weeks. The primary objective of this study is to evaluate the effect of the inhaled corticosteroid FF on bone mineral density assessed at the total hip by comparing FF/VI treatment with VI treatment in subjects with moderate COPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluticasone Furoate/Vilanterol 100/25 micrograms (mcg) QD | Experimental | Drug: Fluticasone Furoate/VilanterolSubjects will self administer FF/VI 100/25 mcg inhalation powder once daily for 156 weeks via the NDPI. |
| Vilanterol 25 mcg QD | Experimental | Drug: VilanterolSubjects will self administer VI 25 mcg inhalation powder once daily for 156 weeks via the NDPI. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Informed consent: Subjects must give their signed and dated written informed consent to participate.
- Gender: Male or female subjects. Female subjects must be post-menopausal or using a highly effective method for avoidance of pregnancy. The decision to include or exclude women of childbearing potential may be made at the discretion of the investigator in accordance with local practice in relation to adequate contraception.
- Age: >= 40 years of age at Screening (Visit 1)
- COPD diagnosis: Subjects with a clinical history of COPD in accordance with the following definition by the American Thoracic Society/European Respiratory Society: COPD is a preventable and treatable disease characterized by airflow limitation that is not fully reversible. The airflow limitation is usually progressive and is associated with an abnormal inflammatory response of the lungs to noxious particles or gases, primarily caused by cigarette smoking. Although COPD affects the lungs, it also produces significant systemic consequences.
- Tobacco use: Subjects with a current or prior history of >=10 pack-years of cigarette smoking at screening (Visit 1). Former smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1. Number of pack years = (number of cigarettes per day/20) x number of years smoked Note: Pipe and/or cigar use cannot be used to calculate pack year history.
Key exclusion criteria (32 listed)
- Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study.
- Asthma: Subjects with a current diagnosis of asthma. (Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD).
- Alpha1-antitrypsin deficiency: Subjects with alpha-1 antitrypsin deficiency as the underlying cause of COPD.
- Other respiratory disorders: Subjects with tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases.
- Lung resection or transplantation: Subjects with lung volume reduction surgery within the 12 months prior to Screening Visit 1 or having had a lung transplant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluticasone Furoate/VilanterolDry white powder containing 100 mcg of Fluticasone Furoate blended with lactose per blister was administered by NDPI. Dry white powder containing 25 mcg of Vilanterol micronised drug (as the 'M' salt triphenylacetate) blended with lactose and magnesium stearate per blister was administered by NDPI. | Drug | Fluticasone Furoate/Vilanterol 100/25 micrograms (mcg) QD |
| VilanterolDry white powder containing 25 mcg of Vilanterol micronised drug (as the 'M' salt triphenylacetate) blended with lactose and magnesium stearate per blister was administered by NDPI. | Drug | Vilanterol 25 mcg QD |
Primary outcome
Percentage Change From Baseline in Bone Mineral Density (BMD) Measured at Total Hip
Time frame: Baseline (Visit 1) and 26, 52, 78, 104, 130 and 156 Weeks
BMD analysis performed on log (BMD ratio to baseline) using a repeated measures model with covariates of treatment group, age, gender, baseline BMI, visit, log baseline BMD, log baseline BMD by visit and treatment group by visit interactions. These estimates were then converted into annual changes and averaged to calculate the overall treatment estimates and difference which were used for testing non-inferiority. The analysis shown is for the "While on Treatment" estimand of the difference in percentage change from baseline per annum between FF/VI ± BMD medication/SCS (systemic corticosteroids) and VI ± BMD medication/SCS. Baseline is defined as the measurement performed at Visit 1. Percentage change is calculated as (BMD value post-Baseline divided by Baseline value) -1 multiplied by 100.
5 secondary outcomes
Percentage Change From Baseline in BMD Measurements at Total Hip by Gender (Male Participants)
Time frame: Baseline (Visit 1) and 26, 52, 78, 104, 130 and 156 Weeks
Percentage Change From Baseline in BMD Measurements at Total Hip by Gender (Female Participants)
Time frame: Baseline (Visit 1) and 26, 52, 78, 104, 130 and 156 Weeks
Percentage Change From Baseline in BMD Measurements at Lumbar Spine (L1 to L4) by Gender (Male Participants)
Time frame: Baseline (Visit 1) and 26, 52, 78, 104, 130 and 156 Weeks
Percentage Change From Baseline in BMD Measurements at Lumbar Spine (L1 to L4) by Gender (Female Participants)
Time frame: Baseline (Visit 1) and 26, 52, 78, 104, 130 and 156 Weeks
Percentage Change From Baseline in BMD Measurements at Lumbar Spine (L1 to L4)
Time frame: Baseline (Visit 1) and 26, 52, 78, 104, 130 and 156 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
45 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fluticasone Furoate/Vilanterol and Vilanterol in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 45 sites in 5 countries.
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 7 inclusion and 32 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 10 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in United States, Netherlands, Spain, Germany, Canada. 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 10 Apr 2019). 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?
Percentage Change From Baseline in Bone Mineral Density (BMD) Measured at Total Hip (time frame: Baseline (Visit 1) and 26, 52, 78, 104, 130 and 156 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Apr 2019.