Mepolizumab for Chronic Obstructive Pulmonary Disease (COPD)

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Chronic Obstructive Pulmonary Disease (COPD)Mepolizumab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing mepolizumab as a possible treatment for COPD. 800 people will be randomly assigned to either the treatment group or the placebo group. The treatment group will receive mepolizumab and the placebo group will not receive the treatment. The trial will last for up to 104 weeks.

Video Summary

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: Up to Week 104

Up to Week 104
Annualized rate of exacerbations requiring Emergency Department (ED) visit or hospitalization
Heart rate
Time to first moderate or severe exacerbation
Week 52
Number of COPD assessment test (CAT) responders
Number of Evaluating Respiratory Symptoms in COPD (E-RS: COPD) responders
Number of St. George's Respiratory Questionnaire (SGRQ) total score responders

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Mepolizumab 300mg
32%Headache
22%Arthralgia
21%Upper respiratory tract infection
21%Sinusitis
18%Nasopharyngitis
18%Diarrhoea
16%Nausea
16%Vomiting
15%Fatigue
15%Asthma
13%Injection site reaction
13%Rash
12%Back pain
12%Oropharyngeal pain
12%Neck pain
10%Influenza
10%Bronchitis
10%Pyrexia
9%Myalgia
9%Acute sinusitis
9%Pruritus
9%Musculoskeletal pain
9%Productive cough
9%Sinus congestion
7%Rhinitis
7%Urinary tract infection
7%Respiratory tract infection
7%Asthenia
7%Cough
7%Gastroenteritis
7%Abdominal pain upper
7%Pain in extremity
7%Wheezing
7%Vertigo
7%Alanine aminotransferase increased
6%Conjunctivitis
6%Urticaria
6%Paraesthesia
6%Nasal congestion
6%Vision blurred
6%Fungal skin infection
6%Oral herpes
6%Ligament sprain
6%Weight increased
4%Influenza like illness
4%Hot flush
4%Oedema peripheral
4%Skin lesion
4%Migraine
4%Adrenal insufficiency
4%Sneezing
4%Epistaxis
4%Dizziness
4%Otitis media
4%Viral infection
4%Muscle spasms
4%Cataract
4%Eye pruritus
4%Laceration
4%Contusion
4%Aspartate aminotransferase increased
4%Gamma-glutamyltransferase increased
3%Insomnia
3%Sinus headache
3%Upper-airway cough syndrome
3%Injection site pain
3%Abdominal pain
3%Joint swelling
1%Cerebellar ischaemia
1%Cardiac arrest
1%Dyspnoea
1%Perirectal abscess
1%Chest pain
1%Enterococcal infection
1%Parainfluenzae virus infection
1%Facial paresis
1%Lacunar infarction
1%Nystagmus
1%Pachymeningitis
1%Hernia
1%Hypersensitivity
1%Ear infection
1%Gastrooesophageal reflux disease
1%Dyspepsia
1%Ear discomfort
This histogram enumerates side effects from a completed 2016 Phase 3 trial (NCT02020889) in the Mepolizumab 300mg ARM group. Side effects include: Headache with 32%, Arthralgia with 22%, Upper respiratory tract infection with 21%, Sinusitis with 21%, Nasopharyngitis with 18%.

Trial Design

2 Treatment Groups

Mepolizumab
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

800 Total Participants · 2 Treatment Groups

Primary Treatment: Mepolizumab · Has Placebo Group · Phase 3

Mepolizumab
Biological
Experimental Group · 1 Intervention: Mepolizumab · Intervention Types: Biological
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mepolizumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to week 104

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,651 Previous Clinical Trials
7,949,389 Total Patients Enrolled
51 Trials studying Chronic Obstructive Pulmonary Disease (COPD)
18,218 Patients Enrolled for Chronic Obstructive Pulmonary Disease (COPD)
PPDIndustry Sponsor
148 Previous Clinical Trials
30,744 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,562 Previous Clinical Trials
6,132,805 Total Patients Enrolled
2 Trials studying Chronic Obstructive Pulmonary Disease (COPD)
112 Patients Enrolled for Chronic Obstructive Pulmonary Disease (COPD)

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are female and you are not using a contraceptive method.
You are not pregnant or breastfeeding, and you are not a woman of childbearing potential (WOCBP) or you are a WOCBP and using a contraceptive method that is highly effective, with a failure rate of <1%, during the intervention period and for at least 16 weeks after the last dose of study intervention
You are 40 years of age or older.

Who else is applying?

What state do they live in?
North Carolina25.0%
New York25.0%
Florida25.0%
Other25.0%
How old are they?
18 - 6550.0%
65+50.0%
What site did they apply to?
GSK Investigational Site100.0%
What portion of applicants met pre-screening criteria?
Met criteria62.5%
Did not meet criteria37.5%
How many prior treatments have patients received?
0100.0%