Your session is about to expire
← Back to Search
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
Awards & highlights
FRONTIER-4 Trial Summary
This trial will test whether an investigational drug is safe and effective for treating adults with Chronic Obstructive Pulmonary Disease and Chronic Bronchitis.
Eligible Conditions
- Chronic Obstructive Pulmonary Disease
- Chronic Bronchitis
FRONTIER-4 Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline to Week 12 in pre-bronchdilator forced expiratory volume in 1 second (FEV1) measured in clinic.
Secondary outcome measures
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 2022 Phase 2 trial • 148 Patients • NCT0421216911%
Eczema
11%
Nasopharyngitis
11%
Pain in extremity
11%
Pruritus
6%
Abdominal discomfort
6%
Oral herpes
6%
Dyspnoea
6%
Dry mouth
6%
Palpitations
6%
Injection site reaction
6%
Otitis externa
6%
Diarrhoea
6%
Covid-19 pneumonia
6%
Venous thrombosis limb
6%
Fall
6%
Bronchitis
6%
Arthropod bite
6%
Conjunctivitis
6%
Urinary tract infection
6%
Eczema infected
6%
Gastroenteritis viral
6%
Myalgia
6%
Insomnia
6%
Injection site bruising
6%
Influenza
6%
Cellulitis
6%
Injection site swelling
6%
Oropharyngeal pain
6%
Influenza like illness
100%
80%
60%
40%
20%
0%
Study treatment Arm
MEDI3506 Dose 2
MEDI3506 Dose 1
MEDI3506 Dose 3
Placebo
FRONTIER-4 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
4,259 Previous Clinical Trials
288,593,766 Total Patients Enrolled
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.
Chronic Obstructive Pulmonary Disease Patient Testimony for trial: Trial Name: NCT04631016 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has recruitment for this scientific experiment commenced?
"Clinicaltrials.gov has data indicating that this clinical trial is actively seeking participants, as the study was initially posted on December 14th 2020 and last updated on September 29th 2022."
Answered by AI
Does my profile meet the requirements to become a participant in this medical research?
"To participate in this experiment, volunteers must have chronic bronchitis and be between 40-80 years old. In total, 144 individuals need to join the trial."
Answered by AI
How many individuals have joined this medical investigation?
"Affirmative. According to the clinicaltrials.gov listing, this medical experiment is still recruiting participants who were first invited on December 14th 2020 and updated most recently on September 29th 2022. 144 people need to be recruited from 29 different sites in total."
Answered by AI
What safety concerns have been documented in regard to MEDI3506?
"Considering the Phase 2 status of MEDI3506, our team gauged its safety at a score of two due to limited data supporting efficacy."
Answered by AI
How many healthcare centers are conducting this research in the city?
"The trial is currently recruiting out of 29 different medical centres, located across cities such as Fort Mitchell, Winter Park and Boerne. To reduce the need for extensive travelling, it is advised to pick a clinic that's closest to you."
Answered by AI
Are seniors eligible to partake in the trial?
"As per the requirements of this clinical trial, would-be participants must be aged 40 or over but not older than 80."
Answered by AI
Who else is applying?
What state do they live in?
Oregon
Florida
California
Other
How old are they?
65+
What site did they apply to?
Research Site
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
0
Why did patients apply to this trial?
To find a better medication then I have now. I want to improve my quality of life & prolong my life!
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
When will I know.?
PatientReceived 1 prior treatment
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger