A Phase II, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety and Tolerability of MEDI3506 in Participants With Moderate to Severe Chronic Obstructive Pulmonary Disease and Chronic Bronchitis (FRONTIER 4) (FRONTIER-4)

  • STATUS
    Recruiting
  • End date
    Oct 17, 2023
  • participants needed
    144
  • sponsor
    AstraZeneca
Updated on 21 October 2022
body mass index
antibiotics
corticosteroids
COPD
pulmonary disease
cough
spirometry

Summary

This is a research study to determine the efficacy and safety of investigational drug MEDI3506 for the treatment of adult subjects with Chronic Obstructive Pulmonary Disease and Chronic Bronchitis.

Description

Study D9180C00002 is a Phase II, randomised, double-blind, placebo-controlled, parallel group, proof of concept study to evaluate the efficacy and safety of MEDI3506 in adult participants with moderate to severe Chronic Obstructive Pulmonary Disease and Chronic Bronchitis.

Approximately 100 sites globally will participate in this study. Approximately 144 participants will be randomized to 2 treatment groups in a 1:1 ratio to receive MEDI3506 or placebo.

Details
Condition Chronic Obstructive Pulmonary Disease (COPD), Chronic Bronchitis
Treatment Placebo, MEDI3506
Clinical Study IdentifierNCT04631016
SponsorAstraZeneca
Last Modified on21 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Provision of informed consent
Participant must be 40 to 80 years of age inclusive, at the time of signing the ICF
Participants who are current or ex-smokers with a tobacco history of ≥ 10 pack-years
Participants who have a documented history of COPD for at least 1 year
Participants who have a post-BD FEV1/FVC < 0.70 and a post-BD FEV1 >= 20% and < 80% predicted normal value at screening. Centralized spirometry will be used for this criteria assessment
Participants who have a physician confirmed participant history of chronic bronchitis as defined as presence of cough and sputum on most days for ≥ 3 months/year in at least the 2 year period immediately prior to SV1(Screening)
Participants who have an average BCSS score of ≥ 2 in cough and ≥ 2 in sputum domains assessed over 14 days preceding SV3
Participants who have a documented stable regimen of dual therapy or triple therapy for ≥ 3 months prior to enrolment; there should have been no change in treatment after the previous exacerbation prior to entering into the study. Where dual therapy consists of ICS + LABA or LABA + LAMA, and triple therapy consists of ICS + LABA + LAMA
Participants who have a documented history of ≥ 1 moderate or severe AECOPD requiring systemic corticosteroids and/or antibiotics for at least 3 days duration (or 1 injection of depot formulation), or hospitalization for reason of AECOPD in the previous 24 months
Body mass index within the range 18 to 40 kg/m2 (inclusive)
Female participants of childbearing potential, must have negative pregnancy tests
Male and female participants must follow protocol contraceptive guidance

Exclusion Criteria

Participants with a positive diagnostic nucleic acid test for SARS-CoV-2 at screening. Subjects with mild or asymptomatic disease could be rescreened
Participants with a significant COVID-19 illness within 6 months of enrolment
As judged by the investigator, any evidence of any active medical or psychiatric condition or other reason which in the investigator's opinion makes it undesirable for the participant to participate in the study
Current or past diagnosis of asthma which persisted beyond age of 25 years
Clinically important pulmonary disease other than COPD, radiological findings, and/or laboratory findings suggestive of a respiratory disease other than COPD that is contributing to the participant's respiratory symptoms
Increased pre-BD FEV1 at randomization visit (SV3) compared to Screening SV1 of ≥ 400 mL or ≥ 25% of SV1 FEV1
Chest CT scan findings requiring further investigation or repeat CT surveillance before
Any other clinically relevant abnormal findings on physical examination, laboratory testing; or chest CT scan, which in the opinion of the investigator or medical monitor may compromise the safety of the participant in the study or interfere with evaluation of the study intervention or reduce the participant's ability to participate in the study
SV14
A family history of heart failure
A LVEF < 45% measured by echocardiogram
History of a clinically significant infection (viral, bacterial, or fungal) within 4
weeks
History of, or a reason to believe a participant has a history of, drug or alcohol
abuse within the past 2 years prior to screening
Evidence of active or untreated latent TB
Participants with a recent history of, or who have a positive test for, infective
hepatitis or unexplained jaundice, or participants who have been treated for hepatitis
B, hepatitis C, or HIV
Receiving any of the prohibited concomitant medications as specified in the CSP
Change in smoking status in 12 weeks prior to enrolment or intention to change smoking
Inability to perform technically acceptable spirometry
status between enrolment and end of follow-up
Additional inclusion and exclusion criteria's applies
Participants currently receiving background therapy that is not approved by regulatory
authorities in the country of study for COPD are not eligible for the study
History of treatment with cardiotoxic medications (eg, as part of cancer therapy)
including thiazolidinedione's
Treatment with broad spectrum antibiotic within 4 weeks prior to randomization (Day
)
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note