This is a clinical study designed to explore the safety, effectiveness and optimum dose of the medicine MED-563 in adult patients who suffer from asthma that is not fully controlled by other treatments
- Conditions
- ncontrolled AsthmaMedDRA version: 14.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2010-020126-17-BG
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 482
1. Age 18 through 75 years at the time informed consent is obtained.
2. Written informed consent and any locally required authorization (eg, HIPAA in the USA, EU Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluatons.
3. Female subjects of childbearing potential who are sexually active with non-sterilized male partner must use adequate contraception from the date informed consent is obtained 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 Table 4.2.1-1 of the protocol. Sustained abstinence is an acceptable practice; however, periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception.
4. Non-sterilized males who are sexually active with a female of child-bearing potential must use adequate contraception from the date informed consent is obtained through the end of the study.
5. Females or female partners not of childbearing potential must have been surgically sterilized (eg, hysteroctomy, 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.
6. Sterilized males must be at least 1 year post vasectomy.
7. Weight of > 45 kg but equal to or less than 150 kg (>100 lb but equal to or less than 330 lb).
8. History of physician-diagnosed asthma for at least 12 months prior to the date informed consent is obtained.
9. Morning pre-bronchodilator forced expiratory volume in 1 second (FEV1) value of more than or equal to 40% and <90% predicted during the screening/run-in period.
10. Meeting any one of the following criteria: a) Proof of post-bronchodilator reversibility of airflow obstruction more than or equal to 12% documented within 36 months prior to randomization or proof of a positive response [PC20 less than or equal to 8 mg/mL (ATS, 2000)] to a methacholine challenge documented within 36 months prior to randomization; OR b) A post-bronchodilator increase in FEV1 greater than or equal to 12% and greater than or equal to 200ml at Week -3 screening visit: OR c) If a) and b) are not met and all other inclusion/exclusion criteria are met, subjects with a FEV1 of more than or equal to 1.5 L and more than or equal to 60% predicted on the Week -2 screening visit will be eligible to undergo a methacholine challenge at the Week -2 screening visit at sites where methacholine testing is available. If the subject achieves a positive response to this methacholine challenge (PC20 less than or equal to 8 mg/mL), then this inclusion criterion is met.
11. Physician prescribed daily use of medium-dose or high-dose ICS (as defined in GINA Report 2009) plus LABA or any combination of sequential dosing of either medium dose or high dose ICS/LABA for at least 12 months prior to the date informed consent is obtained. Dose must be stable for at least 30 days prior to the date informed consent is obtained and during the screening/run-in period.
12. Willingness to switch to an ICS/LABA combination product if using individual ICS and LABA inhalers prior to the date informed consent is obtained.
13. Dose of other asthma controller
1. Any condition that, in the opinion of the investigator or medical monitor, would interfere with evaluation of the investigational product or interpretation of subject safety or study results.
2. Concurrent enrolment in another clinical study.
3. Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals.
4. Known history of allergy or reaction to any component of the investigational product formulation.
5. History of anaphylaxis to any biologic therapy.
6. Unexplained abdominal discomfort, nausea, vomiting, decreased appetite, and/or diarrhea within 30 days prior to the date informed consent is obtained & during the 3-week screening/run-in period; diagnosis of helminth parasitic infection resulting from positive stool sample during the 3-week screening/run-in period that has not been treated with, or has failed to respond to, standard of care therapy; or positive serology or stool sample for S stercoralis in subjects with chronic oral corticosteroid-dependent asthma during the 3-week screening/run-in period.
7. Use of immunosuppressive medication (eg methotrexate, troleandomycin, oral gold, cyclosporine, azathioprine, intramuscular long-acting depot corticosteroid, or any experimental anti-inflammatory therapy) within 3 months prior to the date informed consent is obtained. Chronic oral prednisone or equivalent up to 10 mg daily or 20 mg every other day for asthma is allowed.
8. Oral corticosteroid burst or short-acting systemic corticosteroid within 30 days prior to the date informed consent is obtained or during the screening/run-in period.
9. Acute upper or lower respiratory infections requiring antibiotics or antiviral medications within 30 days prior to the the date informed consent is obtained or during the screening/run-in period.
10. Receipt of immunoglobulin or blood products within 30 days prior to the date informed consent is obtained.
11. Receipt of any marketed or investigational biologic within 4 months or 5 half-lives prior to the date informed consent is obtained. whichever is longer. Receipt of vaccinations (eg rubella, measles, chicken pox, vaccinations for travel abroad) is allowed providing administration was not within 3 weeks prior to any study visit.
12. Receipt of any investigational nonbiologic within 30 days or 5 half-lives prior to the date informed consent is obtained, whichever is longer.
13. Previously received MEDI-563.
14. Any clinically relevant abnormal findings in physical examination, vital signs, hematology, clinical chemistry, or urinalysis during screening/run-in period, which in the opinion of the Investigator, may put the subject at risk because of his/her participation in study, or may influence the results of the study, or the subject's ability to participate in the study.
15. Past history of clinically significant cardiac disease or any ECG abnormality obtained during the screening/run-in period, which in the opinion of the Investigator may put the subject at risk or interfere with study assessments.
16. Breastfeeding or lactating women.
17. History of alcohol or drug abuse within 12 months prior to the date informed consent is obtained.
18. History of any known primary immunodeficiency disorder excluding asymptomatic selective IgA or IgG subclass deficiency.
19. Positive hepatitis B surface antigen, or hepatitis C virus antibody serology, or a positive medical history for hepatitis
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method