Add on treatment for COPD for patients who experience frequent exacerbations

  • STATUS
    Recruiting
  • sponsor
    AstraZeneca
Updated on 9 June 2022

Summary

Current or former smokers who are diagnosed with COPD and experienced at least 2 exacerbations- worsening of symptoms requiring steroid treatment or hospitalization despite being on multiple inhaler medications may qualify for this study involving benralizumab subcutaneous injections compared to placebo injections, initially every 4 weeks, then every 8 weeks after the third dose. 

Description

Study Medication: Benralizumab 100 mg subcutaneous injection every 4 weeks for the first 3 doses, then every 8 weeks
Comparator: Placebo subcutaneous injection every 4 weeks for the first 3 doses, then every 8 weeks
Ratio: 1:1
Length of Study: Screening Period up to 13 weeks, Double-Blind Portion up to 56 weeks, followed by end of study visit
Visits: approximately 18 over 60 weeks
Key Study Procedures: Spirometry, Physical Exam, bloodwork, Vitals, Diary, Questionnaires, Chest X-Ray
Compensation: $100.00/Visit completed

Details
Condition COPD (Chronic Obstructive Pulmonary Disease)
Clinical Study IdentifierTX301778
SponsorAstraZeneca
Last Modified on9 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patient must be 40 to 85 years of age inclusive, at the time of signing the ICF
Current smoker or ex-smoker with a tobacco history of ≥10 pack-years (1 pack-year = 20 cigarettes smoked per day for 1 year). (Note: electronic cigarette [e-cigarette] use does not contribute to the pack-year count for eligibility.)
History of moderate to very severe COPD
Documented history of 2 or more moderate and/or severe COPD exacerbations12 that required treatment with systemic corticosteroids (at least 3 days or a single depot formulation injection) and/or hospitalization within 52 weeks prior to enrollment. Documented use of triple (ICS/LABA/LAMA3 ) background therapy for COPD for ≥3 months immediately prior to enrollment

Exclusion Criteria

Clinically important pulmonary disease other than COPD (e.g. active lung infection, clinically significant bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency, and primary ciliary dyskinesia)
Current diagnosis of asthma, according to the Global Initiative for Asthma (GINA) or other accepted guidelines, prior history of asthma, or asthma-COPD overlap according to GINA/GOLD1 Childhood history of asthma is allowed and defined as asthma diagnosed and resolved (i.e. not requiring the use of any maintenance or rescue medication) before the age of 18
Radiological findings suggestive of a respiratory disease other than COPD that is contributing to the patient’s respiratory symptoms. Radiological findings of solitary pulmonary nodules without appropriate follow up and demonstration of stability as per standard of care or results suggestive of acute infection
Another diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts (e.g. allergic bronchopulmonary aspergillosis/mycosis, eosinophilic granulomatosis with polyangiitis, hypereosinophilic syndrome)
Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable in the opinion of the investigator and/or could
\- Affect the safety of the patient throughout the study
\- Influence the findings of the study or their interpretation
\- Impede the patient’s ability to complete the entire duration of the study
Any clinically significant abnormal findings in physical examination, vital signs, ECG, hematology, clinical chemistry, or urinalysis during the run-in period, which in the opinion of the investigator may put the patient at risk because of his/her participation in the study, or may influence the results of the study, or the patient’s ability to complete the entire duration of the study
Signs and/or symptoms of cor pulmonale and/or right ventricular failure
Patients receiving long-term treatment with oxygen >4.0 liters/minute (L/min). While breathing supplemental oxygen, patients should demonstrate an oxyhemoglobin saturation ≥89%. In order to be admitted to the study, patients on long-term oxygen therapy have to
be ambulatory and be able to attend clinic visits
Use, or need for chronic use, of any non-invasive positive pressure ventilation device (NIPPV). Note: Patients using continuous positive airway pressure (CPAP) for Sleep Apnea Syndrome are allowed in the study
History of known immunodeficiency disorder including a positive test for human immunodeficiency virus, HIV-1 or HIV-2
Active liver disease. Chronic stable hepatitis B and C (including positive testing for hepatitis B surface antigen or hepatitis C antibody), or other stable chronic liver disease are acceptable if patient otherwise meets eligibility criteria. Stable chronic liver disease should generally be defined by the absence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice, or cirrhosis
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥3 times the upper limit of normal (ULN), confirmed by repeated testing1 during the run-in period. Transient increase of AST/ALT level that resolves by the time of randomization is acceptable if, in the investigator’s opinion, the patient does not have an active liver disease and meets other eligibility criteria
A helminth parasitic infection diagnosed within 24 weeks prior to the date informed consent is obtained that has not been treated with or has failed to respond to standard of care therapy
History of alcohol or drug abuse within the past year, which may compromise the study data interpretation as judged by investigator or AZ study physician
Malignancy, current or within the past 5 years, except for adequately treated non-invasive basal cell and squamous cell carcinoma of the skin and cervical carcinoma-in-situ treated with apparent success more than 1 year prior to Visit 1. Suspected malignancy or undefined neoplasms
Patients who, in the opinion of the investigator or qualified designee, have evidence of active TB. Patients with a recent (within 2 years) first-time or newly positive purified protein derivative (PPD) test or Quantiferon test need to complete an appropriate course of treatment before being considered for enrollment. Evaluation will be according to the local standard of care and may consist of history and physical examinations, chest X-ray, and/or TB test as determined by local guidelines
Patients participating in, or scheduled for, an intensive (active) COPD rehabilitation program (patients who are in the maintenance phase of a rehabilitation program are eligible to take part)
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...

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