A 12-week Study to Evaluate the Efficacy and Safety of Umeclidinium 62.5 Microgram (mcg) Compared With Glycopyrronium 44 mcg in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02236611
• Date of registration: 08/09/2014
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline
• Public title: A 12-week Study to Evaluate the Efficacy and Safety of Umeclidinium 62.5 Microgram (mcg) Compared With Glycopyrronium 44 mcg in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
• Scientific title: A Randomized, Parallel-group, Open-label Study to Evaluate the Efficacy and Safety of Umeclidinium (UMEC) 62.5 mcg Compared With Glycopyrronium 44 mcg in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
• Date of first enrolment: September 26, 2014
• Target sample size: 1036
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02236611
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Argentina, Chile, Czech Republic, Czechia, Germany, Hungary, Norway, Romania, Russian Federation, Spain, Sweden

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: subjects 40 years of age or older at Visit 1.

- Gender: male and female subjects are eligible to participate in the study. 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. 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, eg, 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 acceptable contraceptive methods
used consistently and correctly i.e., in accordance with the approved product label
and the instructions of the physician for the duration of the study - screening to
follow-up contact.

- Diagnosis: an established clinical history of COPD in accordance with the definition
by the American Thoracic Society/European Respiratory Society (ERS)

- 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 (eg. 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 forced expiratory volume in
one second/ forced vital capacity (FEV1/FVC ratio of <0.70 and a
post-albuterol/salbutamol FEV1 of >=30% and =<70% of predicted normal values at Visit
1. Predicted values will be based upon the ERS Global Lung Function Initiative

- 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 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.

- Severe renal impairment: patients with severe renal impairment (e.g., end-stage renal
disease requiring dialysis) should be excluded, unless in the opinion of the
investigator, the benefit is likely to outweigh the risk.

- Unstable or life threatening cardiac disease: long-acting muscarinic antagonists
(LAMA) 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, 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; sustained or nonsustained ventricular
tachycardia; second degree heart block Mobitz type II or 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.

- 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, inhaled long acting beta2 agonists/ inhaled
corticosteroid (LABA/ICS) combination products if LABA/ICS therapy is discontinued
completely 30 days; LABA/ICS combination products only If discontinuing ICS/ LABA
therapy and switching to ICS monotherapy 48 hours for the salmeterol or formoterol
component 14 days for the vilanterol component (note: the dose of ICS must be a dose
of fluticasone propionate (FP) or equivalent but not to exceed 1000 mcg/day), use of
ICS at a dose >1000 microgram (mcg)/day of FP or equivalent 30 days (note: use of


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

Health Condition(s) or Problem(s) studied

Pulmonary Disease, Chronic Obstructive

Intervention(s)

Drug: Glycopyrronium

Drug: Umeclidinium

Primary Outcome(s)

Change From Baseline in Trough FEV1 on Day 85 [Time Frame: Baseline (BL) and Day 85]

Secondary ID(s)

201315

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 15/02/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02236611