A Phase IIIb Study to Evaluate the Efficacy of Umeclidinium/Vilanterol (UMEC/VI) in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02152605
• Date of registration: 29/05/2014
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline
• Public title: A Phase IIIb Study to Evaluate the Efficacy of Umeclidinium/Vilanterol (UMEC/VI) in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
• Scientific title: A 12 Week, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy of Umeclidinium/Vilanterol 62.5/25mcg in Subjects With COPD
• Date of first enrolment: September 1, 2014
• Target sample size: 498
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02152605
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Bulgaria, Germany, Hungary, Romania, Russian Federation, Ukraine, United States

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion criteria

Inclusion Criteria:

- Type of subject: Outpatient.

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

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

- Gender: Male and female subjects are eligible to participate in the study.

- A female subject 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). Surgically sterile
females are defined as those with a documented hysterectomy and/or bilateral
oophorectomy or tubal ligation. Post-menopausal females are defined as being
amenorrhoeic for greater than 1 year with an appropriate clinical profile (For example
[e.g.] age appropriate, >45 years, in the absence of hormone replacement therapy; or
child bearing potential, has a negative pregnancy test at screening, and agrees to one
of the following acceptable contraceptive methods used consistently and correctly
(i.e. in accordance with the approved product label, if appropriate, and the
instructions of the physician for the duration of the study screening to follow-up
contact): abstinence; oral contraceptive (either combined or progestogen alone);
injectable progestogen; implants of levonorgestrel; estrogenic vaginal ring;
percutaneous contraceptive patches; intrauterine device (IUD) or intrauterine system
(IUS) that meets the SOP effectiveness criteria as stated in the product label; male
partner sterilization (vasectomy with documentation of azoospermia) prior to the
female subject's entry into the study (this male is the sole partner for that
subject); and double barrier method: condom and an occlusive cap (diaphragm or
cervical/vault caps) with a vaginal spermicidal agent
(foam/gel/film/cream/suppository).

- Diagnosis: An established clinical history of COPD in accordance with the definition
by the American Thoracic Society/European Respiratory Society.

- 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 both equal 10 pack-years)]. Former smokers are defined as those
who have stopped smoking for at least 6 months prior to Visit 1. Pipe and/or cigar use
cannot be used to calculate pack-year history.

- Severity of Disease: A pre and post-albuterol/salbutamol FEV1/ Forced Vital Capacity
(FVC) ratio of <0.70 and a post-albuterol/salbutamol FEV1 of <=70% of predicted normal
values calculated using National Health and Nutrition Examination Survey (NHANES) III
reference equations at Visit 1.

- Dyspnea: A score of >=2 on the Modified Medical Research Council (mMRC) Dyspnea Scale
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 conditions in addition to COPD should be excluded. Examples
may include clinically significant bronchiectasis, pulmonary hypertension,
sarcoidosis, or interstitial lung disease.

- Other Diseases/Abnormalities: Any subject who is considered unlikely to survive the
duration of the study period or has any rapidly progressing disease or immediate
life-threatening illness (e.g. cancer). In addition, any subject who has any condition
(e.g. neurological condition) that is likely to affect respiratory function should not
be included in the study.

- Severe Hepatic Impairment: Patients with severe hepatic impairment (Child-Pugh class
C) should be excluded unless, in the opinion of the investigator, the benefit is
likely to outweigh the risk.

- Unstable or life threatening cardiac disease: UMEC/VI should be used with caution in
subjects with severe cardiovascular disease. In the opinion of the investigator, use
should only be considered if the benefit is likely to outweigh the risk in conditions
such as: myocardial infarction or unstable angina in the last 6 months; unstable or
life threatening cardiac arrhythmia requiring intervention in the last 3 months; New
York Heart Association (NYHA) Class IV heart failure.

- Contraindications: Any history of allergy or hypersensitivity to any
anticholinergic/muscarinic receptor antagonist, beta2-agonist, sympathomimetic,
lactose/milk protein or magnesium stearate.

- Antimuscarinic effects: Subjects with medical conditions such as narrow-angle
glaucoma, urinary retention, prostatic hypertrophy, or bladder neck obstruction should
only be included if, in the opinion of the study physician, the benefit outweighs the
risk.

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

- Lung Resection: Lung volume reduction surgery within the 12 months prior to Visit 1.

- 12-Lead Electrocardiogram (ECG): Investigators will be provided with ECG reviews
conducted by a centralized independent cardiologist to assist in evaluation of subject
eligibility. The Investigator will determine the clinical significance of each
abnormal ECG finding in relation to the subject's medical history and exclude subjects
who would be at undue risk by participating in the trial. Subjects with the following
abnormalities are excluded from participation in the study: Atrial fibrillation with
rapid ventricular rate >120 beats per minute (bpm); Sustained or non-sustained
ventricular tachycardia; Second degree heart block Mobitz type II and third degree
heart block (unless pacemaker or defibrillator had been inserted).

- Medication Prior to Spirometry: Unable to withhold albuterol/salbutamol for the 4 hour
period required prior to spirometry testing at each study visit.

- Interactions: Concomitant administration with beta-blockers and strong Cytochrome P450
3A4 (CYP3A4) inhibitors is only permitted if, in the Investigator's opinion, the
likely benefit outweighs the potential risk.

- Medications Prior to Screening: Use of the following medications according to the
following defined time intervals prior to Visit 1: Depot corticosteroids (12 weeks),



Age minimum: 40 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Disease, Chronic Obstructive

Intervention(s)

Drug: Placebo

Drug: UMEC/VI

Primary Outcome(s)

Change From Baseline in Mean St.George's Respiratory Questionnaire (SGRQ) Total Score at Day 84 [Time Frame: Baseline and Day 84]

Secondary Outcome(s)

Change From Baseline (BL) in Mean Number of Puffs of Rescue Medication Per Day Used Over Weeks 1-12 [Time Frame: Week 1 amd Week 12]

Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Day 84 [Time Frame: Baseline and Day 84]

Secondary ID(s)

201211

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 25/02/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02152605