A Phase 2a, double blind, placebo controlled study to evaluate the efficacy of MEDI-563 in subjects with moderate to severe COPD and sputum eosinophilia

Phase 1

• Conditions: Chronic obstructive pulmonary disease and Sputum Eosinophilia; MedDRA version: 13.1 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

• Registration Number: EUCTR2010-020127-52-GB
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-08-03
• Study Completion: 2013-07-11
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 101

Inclusion Criteria

1. Subjects aged 40 to 85 years old at the time of screening.

2. Written informed consent obtained from the subject prior to performing any
protocol-related procedures.

3. Documented history of moderate to severe COPD with a post-bronchodilator
FEV1/FVC < 0.70 and a post-bronchodilator FEV1 < 80% predicted at screening.

4. Documented history of 1 or more AECOPD that required treatment with systemic
corticosteroids and/or antibiotics, or hospitalization within 8 weeks - 52 weeks
prior to Day 1.

5. Eosinophilia: greater or same as 3.0% demonstrated on sputum within 12 months
prior to, or at screening.

6. Clinically stable and free from an acute exacerbation of COPD for 8 weeks prior
to Day 1.

7. Current smoker or ex-smoker with a tobacco history of more than or equal to 10
pack-years (1 pack year = 20 cigarettes smoked per day for 1 year).

8. Female subjects of childbearing potential who are sexually active with non-
sterilized male partner must use adequate contraception from screening through
the end of the study. An acceptable method of contraception is defined as one
that has no higher than a 1% failure rate. In this study, where medications and
devices containing hormones are included, the recommended methods of
contraception are described in the protocol. Sustained abstinence is an
acceptable practice; however, periodic abstinence, the rhythm method, and the
withdrawal method are not acceptable methods of contraception.

9. Non-sterilized males who are sexually active with a female of child-bearing
potential must use adequate contraception (see protocol) from screening
through the end of the study.

10. Females not of childbearing potential must have been
surgically sterilized (eg. hysterectomy, bilateral tubal ligation, or bilateral
oophorectomy) or postmenopausal (defined as at least 1 year since last regular
menses) and follicle stimulating hormone (FSH) > 23 IU/L according to a central
laboratory.

11. Sterilized males must be at least 1-year post vasectomy or must use adequate
contraception if less than 1 year post vasectomy.

12. Ability and willingness to complete follow-up period as required by the protocol.

13. Subjects receiving allergy immunotherapy must be on a stable dose for the
preceding 90 days prior to Day 1.

14. Able to read and write.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Any condition that would interfere with evaluation of the investigational product or interpretation of subject safety or study results
2. Significant or unstable ischemic heart disease, arrhythmia, cardiomyopathy, heart
failure, renal failure, uncontrolled hypertension as defined by Investigator or any other relevant cardiovascular disorder as judged by Investigator
3. Pregnant, breastfeeding or lactating women
4. Known history of allergy/reaction to any component of the investigational product formulation, budesonide/formoterol preparations, tiotropium bromide or terbutaline sulphate or any of their excipients
5. History of anaphylaxis to any other biologic therapy
6. Donation or transfusion of blood, plasma or platelets within past 90 Days prior to
screening
7. Other significant pulmonary disease as a primary diagnosis if a subject is diagnosed with any other pulmonary diseases as a secondary diagnosis they may be included if, in the opinion of the investigator/medical monitor, the inclusion does not compromise the interpretation of the study
8. Receiving long-term oxygen therapy (LTOT) at entry into the study. LTOT is defined as use of oxygen for a min. of 15 hrs per day
9. Subjects who have past or present disease or disorder, which is judged by the investigator and the medical monitor, may either put the subject at risk because of participation in the study, or may affect outcome of the study. Subjects who have epilepsy must be on a stable dose of medication for 30 days prior to Day 1
10. Influenza vaccination within 3 wks before sputum collection at screening (Day -56)
11. Fever >37.8 °C (>100°F) measured using the tympanic temperature (or equiv. oral/rectal/axillary temperature) at Day 1
12. Use of immunosuppressive medication, including inhaled (other than Symbicort®),
topical, ocular, nasal or rectal corticosteroids & systemic steroids within 28 days before randomization (Day 1) into the study
13. Receipt of immunoglobulin or blood products within 30 days before randomization into the study
14. Receipt of any novel investigational medicinal products within 3 months before
the first dose of investigational product in this study and through to study end.
15. Seropositive for hepatitis B surface antigen, hepatitis C, or human immunodeficiency virus (HIV)-1 or HIV-2)
16. Unexplained diarrhea within 30 days prior to screening; or diagnosis of helminth parasitic infestation within 6 months prior to screening; history of untreated systemic helminth parasitic infection; history of living with person known to have had a helminth parasitic infestation within 12 months prior to screening; history of recent travel to areas where parasite infestations are endemic within 3 months before screening
17. Any subjects that have positive serum serology during screening/run-in period to Strongyloides stercoralis will be excluded. Subjects with positive serology to Schistosoma mansoni, Taenia solium, or Ascaris lumbricoides will undergo a confirmatory stool sampling per local guidelines1. If stool sampling is positive for Schistosoma mansoni or Taenia solium the subject will be excluded. All s

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified