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)
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)MedDRA version: 16.1Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 100000004855Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2012-004801-28-ES
- Lead Sponsor
- GlaxoSmithKline, S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 280
1. Informed consent: Subjects must give their signed and dated written informed consent to participate.
2. 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.
3. Age: >= 40 years of age at Screening (Visit 1)
4. COPD diagnosis: Subjects with a clinical history of COPD in accordance with the following definition by the American Thoracic Society/European Respiratory Society [Celli, 2004]: 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.
5. 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.
6. Severity of Disease: Subject with a measured post albuterol/salbutamol FEV1/FVC ratio of < 0.70 at Screening (Visit 1). Subjects with a measured post-albuterol/salbutamol 50%>= FEV1 <=70% of predicted normal values calculated usingNHANES III reference equations [Hankinson, 1999] at Screening (Visit 1).
7. Native Hip: Have at least one evaluable native hip.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 240
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40
1. Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study.
2. 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).
3. alfa1-antitrypsin deficiency: Subjects with alfa-1 antitrypsin deficiency as the underlying cause of COPD.
4. Other respiratory disorders: Subjects with tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases.
5. 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.
6. Chest X-ray: Subjects with a chest X-ray (or 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.
7. 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.
8. 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. view protocol for further information.
9. 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.
10. Abnormal and clinically significant 12-lead ECG: Subjects who have an abnormal, clinically significant ECG finding at Screening Visit 1.
11. 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.
12. Bone disorders/conditions: Subjects with historical or current evidence of various bone disorders/conditions, please view protocol for further information.
13. Immobility: Wheel chair bound or paraplegic.
14. Low vitamin D: Previously known low-serum 25-hydroxy vitamin D concentration (less than 10ng [25nmoles] per liter).
15. Other diseases/abnormalities: Serious, uncontrolled disease (including serious psychological disorders) likely to interfere with the study within the 3-year study.
16. Cancer: Subjects with carcinoma that has not been in complete remission for at least 5 years. view protocol for furhter information.
17. Drug/food allergy: Subjects with a history of hypersensitivity to any of the study medications (view protocol for further information), participation will also be excluded.
18. Drug/alcohol abuse: Subjects with a known or suspected history of alcohol or drug abuse within the last 2 years.
19. 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: Please v
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 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.;Secondary Objective: A secondary objective is to evaluate the effect of the inhaled corticosteroid Fluticasone Furoate (FF) on bone mineral density by gender by comparing FF/VI treatment with VI treatment in subjects with moderate COPD.<br><br>Another secondary objective is to evaluate the effect of FF on bone mineral density as assessed at the lumbar spine (L1-L4) by comparing FF/VI treatment with VI treatment in subjects with moderate COPD.;Primary end point(s): BMD measured at the total hip;Timepoint(s) of evaluation of this end point: BMD assessment between Visit 1 and Visit 2 and every 6 months following Visit 2 (i.e., Visits 4, 6, 8, 10, 12, 14)
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - BMD measured at the lumbar spine (L1-L4)<br>- BMD measurements by gender.<br><br>Other Endpoints<br>- Adverse Event reporting<br>- Serious Adverse Event reporting <br>- Incidence of fractures<br>- Incidence of pneumonias<br>- COPD exacerbations;Timepoint(s) of evaluation of this end point: BMD assessment between Visit 1 and Visit 2 and every 6 months following Visit 2 (i.e., Visits 4, 6, 8, 10, 12, 14)