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A Study to Evaluate the Efficacy and Safety of Umeclidinium Bromide/Vilanterol Compared With Fluticasone Propionate/Salmeterol Over 12 Weeks in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

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

Condition(s) targeted: Pulmonary Disease, Chronic Obstructive

Intervention: Umeclidinium bromide/Vilanterol (Drug); Placebo ACCUHALER/DISKUS (Drug); Fluticasone propionate/Salmeterol (Drug); Placebo NDPI (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

Summary

This is a multicenter, randomized, double-blind, double-dummy, parallel group study. The purpose of this study is to compare the efficacy and safety of umeclidinium/vilanterol (UMEC/VI) and fluticasone propionate/salmeterol (FSC) in subjects with Chronic Obstructive Pulmonary Disease (COPD). Subjects who meet the eligibility criteria at Screening will complete a 7 to 14 day Run-in period. At the end of the run-in period, approximately 710 eligible subjects will be equally randomized (to complete at least 568 evaluable subjects) to one of the 2 treatment groups for 12 weeks: 1. UMEC/VI 62. 5/25 micrograms (mcg) administered as one inhalation once-daily in the morning via the Novel dry powder inhaler (NDPI) + placebo administered as one inhalation each morning and evening via single multidose powdered inhaler (ACCUHALER/DISKUS) or 2. FSC 500/50 mcg administered as one inhalation each morning and evening via ACCUHALER/DISKUS + placebo administered once-daily in the morning via NDPI. A safety Follow-up assessment will be conducted approximately 7 days after the end of the study treatment (Early Withdrawal, if applicable). The total duration of subject participation will be approximately 15 weeks.

Clinical Details

Official title: DB2116134: A Randomized, Multi-center, Double-blind, Double-dummy, Parallel Group Study to Evaluate the Efficacy and Safety of Umeclidinium Bromide/Vilanterol Compared With Fluticasone Propionate/Salmeterol Over 12 Weeks in Subjects With COPD

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Change From Baseline (BL) in 0 to 24 Hour Weighted Mean Serial Forced Expiratory Volume in One Second (FEV1) at Day 84

Secondary outcome: Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) at Day 85

Eligibility

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Type of subject: Outpatient

- Informed Consent: A signed and dated written informed consent prior to study

participation

- Age: Subjects 40 years of age or older at Visit 1

- Gender: Male or female subjects. A female is eligible to enter and participate in the

study if she is of: Non-child bearing potential (i. e. physiologically incapable of becoming pregnant, including any female who is post-menopausal or surgically sterile); or Child bearing potential, has a negative pregnancy test at screening, and agrees to one of the acceptable contraceptive methods listed in the protocol used consistently and correctly

- Diagnosis: established clinical history of COPD in accordance with the definition by

the American Thoracic Society/European Respiratory Society as follows: Chronic obstructive pulmonary disease is a preventable and treatable disease state 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.

- Smoking history: Current or former cigarette smokers with a history of cigarette

smoking of >=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)]. Previous smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1. Pipe and/or cigar smoking cannot be used to calculate pack year history.

- Severity of disease: A pre and post-salbutamol FEV1/FVC ratio of <0. 70 and a

post-salbutamol FEV1 of >=30% and <=70% of predicted normal values calculated using NHANES III reference equations at Visit 1.

- Dyspnea: A score of >=2 on the Modified Medical Research Council Dyspnea Scale

(mMRC) at Visit 1. Exclusion Criteria:

- Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant

during the study

- Asthma: A current diagnosis of asthma

- Other Respiratory Disorders: Known alpha-1 antitrypsin deficiency, active lung

infections (such as tuberculosis), and lung cancer are absolute exclusionary conditions. A subject, who, in the opinion of the investigator, has any other significant respiratory condition in addition to COPD should be excluded. Examples may include clinically significant bronchiectasis, pulmonary hypertension, sarcoidosis, or interstitial lung disease. Inactive tuberculosis in more than one lobe is exclusionary. Allergic rhinitis is not exclusionary.

- Other Diseases/Abnormalities: Subjects with historical or current evidence of

clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled and/or a previous history of cancer in remission for <5 years prior to Visit 1 (localized carcinoma of the skin that has been resected for cure is not exclusionary). Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study.

- Contraindications: A history of allergy or hypersensitivity to any

anticholinergic/muscarinic receptor antagonist, beta2-agonist, corticosteroid, lactose/milk protein or magnesium stearate or a medical condition such as narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that, in the opinion of the study physician contraindicates study participation or use of an inhaled anticholinergic.

- Hospitalization: Hospitalization for pneumonia within 12 weeks prior to Visit 1

- History of COPD Exacerbation: A documented history of at least one COPD exacerbation

in the 12 months prior to Visit 1 that required either oral corticosteroids, antibiotics, and/or hospitalization. Prior use of antibiotics alone does not qualify as an exacerbation history unless the use was associated with treatment of worsening symptoms of COPD, such as increased dyspnea, sputum volume, or sputum purulence.

- Lung Resection: Subjects with lung volume reduction surgery within the 12 months

prior to Screening (Visit 1)

- 12-Lead ECG: An abnormal and significant electrocardiogram (ECG) finding from the

12-lead ECG conducted at Visit 1. Investigators will be provided with ECG reviews conducted by a centralized independent cardiologist to assist in evaluation of subject eligibility.

- Medication Prior to Spirometry: Unable to withhold salbutamol for the 4 hour period

required prior to spirometry testing at each study visit.

- Medications Prior to Screening: Use of the following medications according to the

following defined time intervals prior to Visit 1: Depot corticosteroids - 12 weeks,

Systemic, oral or parenteral corticosteroids - 6 weeks, Antibiotics (for lower

respiratory tract infection) - 6 weeks, Cytochrome P450 3A4 strong inhibitors - 6

weeks, Herbal medications potentially containing oral or systemic steroids - 6 weeks,

Inhaled corticosteroids (ICS) - 30 days, Long-acting beta2-agonist (LABA)/ICS

combination products - 30 days, Phosphodiesterase 4 (PDE4) inhibitors (e. g.,

roflumilast) - 14 days, Inhaled long-acting anticholinergics - 7 days, Theophyllines

- 48 hours, Oral leukotriene inhibitors (zafirlukast, montelukast, zileuton) - 48

hours, Oral beta2-agonists Long-acting-48 hours/Short-acting - 12 hours, Inhaled long

acting beta2-agonists (LABA, e. g., salmeterol, formoterol, indacaterol) - 48 hours,

Inhaled sodium cromoglycate or nedocromil sodium - 24 hours, Inhaled short acting

beta2-agonists - 4 hours, Inhaled short-acting anticholinergics - 4 hours, Inhaled

short-acting anticholinergic/short-acting beta2-agonist combination products - 4

hours, Any other investigational medication - 30 days or within 5 drug half-lives

(whichever is longer)

- Oxygen: Use of long-term oxygen therapy (LTOT) described as oxygen therapy prescribed

for greater than 12 hours a day. As-needed oxygen use (i. e., <=12 hours per day) is not exclusionary.

- Nebulized Therapy: Regular use (prescribed for use every day, not for as-needed use)

of short-acting bronchodilators (e. g., salbutamol) via nebulized therapy.

- Pulmonary Rehabilitation Program: Participation in the acute phase of a pulmonary

rehabilitation program within 4 weeks prior to Visit 1. Subjects who are in the maintenance phase of a pulmonary rehabilitation program are not excluded.

- Drug or Alcohol Abuse: A known or suspected history of alcohol or drug abuse within

2 years prior to Visit 1.

- Affiliation with Investigator Site: A subject will not be eligible for this study if

he/she is an immediate family member of the participating investigator, sub-investigator, study coordinator, or employee of the participating investigator

- Inability to read: A subject will not be eligible for the study if in the opinion of

the investigator the subject cannot read.

Locations and Contacts

GSK Investigational Site, Benesov 256 30, Czech Republic

GSK Investigational Site, Cvikov 471 54, Czech Republic

GSK Investigational Site, Kralupy nad Vltavou 278 01, Czech Republic

GSK Investigational Site, Kromeriz 767 55, Czech Republic

GSK Investigational Site, Praha 5 150 00, Czech Republic

GSK Investigational Site, Rokycany 337 01, Czech Republic

GSK Investigational Site, Teplice 415 10, Czech Republic

GSK Investigational Site, Trebic 674 01, Czech Republic

GSK Investigational Site, Hvidovre 2650, Denmark

GSK Investigational Site, København 2400, Denmark

GSK Investigational Site, Odense C 5000, Denmark

GSK Investigational Site, Roskilde 4000, Denmark

GSK Investigational Site, Berlin 10117, Germany

GSK Investigational Site, Berlin 10629, Germany

GSK Investigational Site, Berlin 10717, Germany

GSK Investigational Site, Berlin 10787, Germany

GSK Investigational Site, Berlin 10789, Germany

GSK Investigational Site, Berlin 13125, Germany

GSK Investigational Site, Balassagyarmat 2660, Hungary

GSK Investigational Site, Budaörs 2040, Hungary

GSK Investigational Site, Debrecen 4032, Hungary

GSK Investigational Site, Debrecen 4043, Hungary

GSK Investigational Site, Farkasgyepű 8552, Hungary

GSK Investigational Site, Gödöllő 2100, Hungary

GSK Investigational Site, Miskolc 3529, Hungary

GSK Investigational Site, Mosonmagyaróvár 9200, Hungary

GSK Investigational Site, Nyíregyháza 4400, Hungary

GSK Investigational Site, Pecs H-7621, Hungary

GSK Investigational Site, Szeged 6722, Hungary

GSK Investigational Site, Szikszó 3800, Hungary

GSK Investigational Site, Székesfehérvár 8000, Hungary

GSK Investigational Site, Dordrecht 3318 AT, Netherlands

GSK Investigational Site, Eindhoven 5623 EJ, Netherlands

GSK Investigational Site, Heerlen 6419 PC, Netherlands

GSK Investigational Site, Hoorn 1624 NP, Netherlands

GSK Investigational Site, Kloosterhaar 7694 AC, Netherlands

GSK Investigational Site, Sneek 8601 ZR, Netherlands

GSK Investigational Site, Gdansk 80-169, Poland

GSK Investigational Site, Inowroclaw 88-100, Poland

GSK Investigational Site, Krakow 31-024, Poland

GSK Investigational Site, Poznan 60-773, Poland

GSK Investigational Site, Skierniewice 96-100, Poland

GSK Investigational Site, Slupsk 76-200, Poland

GSK Investigational Site, Barnaul 656038, Russian Federation

GSK Investigational Site, Blagoveshchensk 675000, Russian Federation

GSK Investigational Site, Kaluga 248007, Russian Federation

GSK Investigational Site, Kazan 420015, Russian Federation

GSK Investigational Site, Khantymansiysk 628012, Russian Federation

GSK Investigational Site, Moscow 123367, Russian Federation

GSK Investigational Site, Moscow 105 077, Russian Federation

GSK Investigational Site, Moscow 121 309, Russian Federation

GSK Investigational Site, Moscow 123182, Russian Federation

GSK Investigational Site, Moscow 115446, Russian Federation

GSK Investigational Site, Nizhniy Novgorod 603126, Russian Federation

GSK Investigational Site, Orenburg 460018, Russian Federation

GSK Investigational Site, Petrozavodsk 185019, Russian Federation

GSK Investigational Site, Ryazan 390039, Russian Federation

GSK Investigational Site, Saratov 410028, Russian Federation

GSK Investigational Site, St Pertersburg 196247, Russian Federation

GSK Investigational Site, St. Petersburg 194356, Russian Federation

GSK Investigational Site, Tomsk 634 050, Russian Federation

GSK Investigational Site, Ufa 450000, Russian Federation

GSK Investigational Site, Alicante 03004, Spain

GSK Investigational Site, L'Hospitalet de Llobregat 08907, Spain

GSK Investigational Site, Madrid 28041, Spain

GSK Investigational Site, Pama de Mallorca 07010, Spain

GSK Investigational Site, Ponferrada (León) 24411, Spain

GSK Investigational Site, Valladolid 47012, Spain

GSK Investigational Site, Dillingen, Bayern 89407, Germany

GSK Investigational Site, Ruedersdorf, Brandenburg 15562, Germany

GSK Investigational Site, Barcelona, Catalonia 08017, Spain

GSK Investigational Site, Frankfurt am Main, Hessen 60596, Germany

GSK Investigational Site, Frankfurt, Hessen 60389, Germany

GSK Investigational Site, Frankfurt, Hessen 60596, Germany

GSK Investigational Site, Neu isenburg, Hessen 63263, Germany

GSK Investigational Site, Schwerin, Mecklenburg-Vorpommern 19055, Germany

GSK Investigational Site, Delitzsch, Sachsen 04509, Germany

GSK Investigational Site, Dresden, Sachsen 01069, Germany

GSK Investigational Site, Magdeburg, Sachsen-Anhalt 39112, Germany

Additional Information

Starting date: April 2013
Last updated: May 1, 2014

Page last updated: August 23, 2015

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