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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ from study day 1 to week 36
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from study day 1 to week 36
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 moreSide effects data
From 2023 Phase 2 trial • 609 Patients • NCT041705436%
Hyperkalaemia
4%
Diarrhoea
4%
Urinary tract infection
3%
Covid-19
3%
Peripheral swelling
2%
Abdominal pain upper
2%
Constipation
2%
Pruritus
2%
Muscle spasms
2%
Nasopharyngitis
2%
Back pain
1%
Joint effusion
1%
Pain in extremity
1%
Cholecystitis acute
1%
Diverticulum intestinal
1%
Vomiting
1%
Pneumonia aspiration
1%
Renal impairment
1%
Musculoskeletal chest pain
1%
Orthopnoea
1%
Injection site inflammation
1%
Infected dermal cyst
1%
Asthenia
1%
Troponin increased
1%
Hypertension
1%
Bile duct stone
1%
Intervertebral disc degeneration
1%
Fungal skin infection
1%
Bleeding varicose vein
1%
Colitis microscopic
1%
C-reactive protein increased
1%
Dyspnoea
1%
Oedema peripheral
1%
Hypokalaemia
1%
Gastritis erosive
1%
Toothache
1%
Pharyngitis
1%
Cellulitis
1%
Cardio-respiratory arrest
1%
Metabolic acidosis
1%
Hypovolaemia
1%
Foot deformity
1%
Faecaloma
1%
Vaccination complication
1%
Brain natriuretic peptide increased
1%
Weight increased
1%
Vitamin d deficiency
1%
Restless legs syndrome
1%
Acute kidney injury
1%
Coronary artery disease
1%
Decreased appetite
1%
Sleep apnoea syndrome
1%
Drug hypersensitivity
1%
Cardiac failure
1%
Type 2 diabetes mellitus
1%
Gastric polyps
1%
Septic shock
1%
Hypervolaemia
1%
Pancreatitis
1%
Head injury
1%
Hypothyroidism
1%
Cataract
1%
Hypernatraemia
1%
Muscle fatigue
1%
Fall
1%
Abdominal pain
1%
Blood glucose increased
1%
Gastrooesophageal reflux disease
1%
Spinal stenosis
1%
Rash macular
1%
Folliculitis
1%
Dry skin
100%
80%
60%
40%
20%
0%
Study treatment Arm
MEDI3506 60 mg
MEDI3506 300 mg
MEDI3506 120 mg
MEDI3506 30 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
4,411 Previous Clinical Trials
289,123,457 Total Patients Enrolled
4 Trials studying Bronchitis
1,965 Patients Enrolled for Bronchitis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a family history of heart failure, which means someone in your family has had problems with their heart in the past.Your body mass index (BMI) falls between 18 and 40 kg/m2.You have had problems with drugs or alcohol within the past 2 years before the screening.You have smoked cigarettes for at least 10 years, either currently or in the past.You had a serious case of COVID-19 within the past 6 months.You had a serious infection caused by a virus, bacteria, or fungus within the past 4 weeks.You have been diagnosed with COPD (chronic obstructive pulmonary disease) for at least a year.You have been diagnosed with asthma that started before you turned 25 years old and it is still ongoing.You have smoked cigarettes for at least 10 years in your life, whether you currently smoke or have quit.You have been diagnosed with COPD and have had it for at least a year.
Research Study Groups:
This trial has the following groups:- Group 1: MEDI3506
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Bronchitis Patient Testimony for trial: Trial Name: NCT04631016 — Phase 2