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Monoclonal Antibodies

MEDI3506 for Chronic Obstructive Pulmonary Disease (COPD) (FRONTIER-4 Trial)

Phase 2
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from study day 1 to week 36

Summary

This trial is testing a new drug called MEDI3506 to see if it can help adults with serious lung conditions like COPD and Chronic Bronchitis. The study will check if the drug can improve their lung function and reduce symptoms.

Eligible Conditions
  • Bronchitis
  • Chronic Obstructive Pulmonary Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from study day 1 to week 36
This trial's timeline: 3 weeks for screening, Varies for treatment, and from study day 1 to week 36 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline to Week 12 in pre-bronchdilator forced expiratory volume in 1 second (FEV1) measured in clinic.
Secondary study objectives
Anti-drug antibodies during the intervention and follow-up periods.
Area under the PK concentration- time curve, during the intervention and follow up periods.
At Week 12, ratio to baseline in: Daily (ie, 24 hour) cough frequency, Night time cough frequency, Awake time cough frequency
+13 more

Side effects data

From 2023 Phase 2 trial • 609 Patients • NCT04170543
6%
Hyperkalaemia
5%
Hypertension
4%
Oedema peripheral
3%
Diarrhoea
3%
Covid-19
3%
Arthralgia
2%
Urinary tract infection
2%
Vomiting
1%
Herpes zoster
1%
Diabetes mellitus
1%
Type 2 diabetes mellitus
1%
Dry eye
1%
Gout
1%
Pneumonia pseudomonal
1%
Anaemia
1%
Urticaria
1%
Vertigo
1%
Rash
1%
Abdominal pain
1%
Gastritis
1%
Rotator cuff syndrome
1%
Headache
1%
Sinusitis
1%
Haematuria
1%
Arthritis
1%
Platelet count increased
1%
Hypokalaemia
1%
Swelling face
1%
Seasonal allergy
1%
Abdominal distension
1%
Pulse absent
1%
Dysuria
1%
Orthostatic hypotension
1%
Abdominal discomfort
1%
Angina pectoris
1%
Coagulation test abnormal
1%
Fatigue
1%
Acute myocardial infarction
1%
Sars-cov-2 test positive
1%
Pneumonia
1%
Tooth infection
1%
Haemorrhagic stroke
1%
Acute kidney injury
1%
Hypervolaemia
1%
Dizziness
1%
Constipation
1%
Hypoglycaemia
1%
Left ventricular dysfunction
1%
Lumbar spinal stenosis
1%
Muscle spasms
1%
Abdominal pain upper
1%
Injection site pruritus
1%
Nausea
1%
Periarthritis
1%
Limb injury
1%
Hyperuricaemia
1%
Musculoskeletal chest pain
1%
Cellulitis
1%
Chronic kidney disease
1%
Bacteriuria
1%
Nasopharyngitis
1%
Fall
1%
C-reactive protein increased
1%
Back pain
1%
Cerebral haemorrhage
1%
Penile size reduced
1%
Blood creatinine increased
1%
Pain in extremity
1%
Pruritus
1%
Skin ulcer
1%
Toothache
1%
Vision blurred
1%
Cataract
1%
Colitis
1%
Hypotension
1%
Osteomyelitis
1%
Epicondylitis
1%
Ligament sprain
1%
Glycosylated haemoglobin increased
1%
Hypertensive urgency
1%
Influenza
1%
Blood pressure decreased
1%
Blood pressure increased
1%
Dysgeusia
1%
Prostate cancer recurrent
1%
Epistaxis
1%
Erythema
1%
Cholelithiasis
1%
Occult blood positive
1%
Dyspnoea
1%
Lymphopenia
1%
Pyrexia
1%
Covid-19 pneumonia
1%
Cerebrovascular accident
1%
Gastroenteritis
1%
Immunisation reaction
1%
Nail injury
1%
Traumatic haematoma
1%
Hypoglycaemia unawareness
1%
Neck pain
1%
Nephrolithiasis
1%
Renal impairment
100%
80%
60%
40%
20%
0%
Study treatment Arm
MEDI3506 300 mg
MEDI3506 120 mg
MEDI3506 30 mg
MEDI3506 60 mg
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: MEDI3506Experimental Treatment1 Intervention
Approximately 72 participants will be randomized to receive MEDI3506
Group II: PlaceboPlacebo Group1 Intervention
Approximately 72 participants will be randomized to receive placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MEDI3506
2021
Completed Phase 2
~1270

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,388 Previous Clinical Trials
289,109,687 Total Patients Enrolled
4 Trials studying Bronchitis
1,965 Patients Enrolled for Bronchitis

Media Library

MEDI3506 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04631016 — Phase 2
Bronchitis Research Study Groups: MEDI3506, Placebo
Bronchitis Clinical Trial 2023: MEDI3506 Highlights & Side Effects. Trial Name: NCT04631016 — Phase 2
MEDI3506 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04631016 — Phase 2
Bronchitis Patient Testimony for trial: Trial Name: NCT04631016 — Phase 2
~28 spots leftby Nov 2025
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