A Phase 2 Study to Evaluate the Safety and Efficacy of Intravenously Administered MEDI-563

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00768079
First received: October 3, 2008
Last updated: May 3, 2012
Last verified: May 2012
  Purpose

The study will evaluate the effect of two IV dose regimens of MEDI-563 on the proportion of adult subjects with asthma exacerbations who required an urgent healthcare visit for treatment of an acute asthma exacerbation.


Condition Intervention Phase
Asthma
Biological: MEDI-563
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Randomized, Double-blind, Placebocontrolled Study to Evaluate the Safety and Efficacy of Intravenously Administered MEDI-563, A Humanized Anti-interleukin-5 Receptor Alpha Monoclonal Antibody, on Asthma Control Following Acute Exacerbations in Adults

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • Evaluate the effect of two IV dose regimens of MEDI-563 (0.3 and 1.0 mg/kg) on the proportion of subjects with asthma exacerbations at Week 12 in adult subjects who require an urgent healthcare visit for treatment of an acute asthma exacerbation. [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Adverse events will be summarized categorically by system organ class, preferred term,severity, and relationship to investigational product [ Time Frame: Through day 84 ] [ Designated as safety issue: Yes ]

Enrollment: 110
Study Start Date: February 2009
Study Completion Date: May 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
MEDI-563
Biological: MEDI-563
0.3 mg/kg IV MEDI-563 on Study Day 0
Experimental: 2
MEDI-563
Biological: MEDI-563
1.0 mg/kg IV MEDI-563 on Study Day 0
3
Placebo
Other: Placebo
Placebo on Study Day 0 (3mL vials filled with 1.2 mL solution of 10mM histidine, 300 mM glycine, 0.02% polysorbate 20, pH 6.0.)

Detailed Description:

The study will evaluate the effect of two IV dose regimens of MEDI-563 (0.3 and 1.0 mg/kg) on the proportion of adult subjects with asthma exacerbations (relapse and de novo) who required an urgent healthcare visit for treatment of an acute asthma exacerbation.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subjects aged 18 to 60 years at the time of the administration of investigational product.
  • Written informed consent and HIPAA authorization (applies to covered entities in the US only) obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations.
  • Physician-diagnosed asthma with a duration of greater than or equal to 2 years by medical chart or subject report.
  • Had an asthma exacerbation requiring urgent care in the year prior to screening.
  • Meets NHLBI for persistent asthma in the 3 months prior to the current urgent healthcare visit.
  • Current asthma exacerbation that must have lasted greater than or equal to 2 hours prior to arrival to the urgent healthcare setting.
  • Requires at least 2 treatments of inhaled bronchodilators for the current asthma exacerbation in the urgent healthcare setting or within the emergency medical system (EMS)for greater than or equal to 1 hour.
  • Shows an FEV1 or PEF of not more than 70% predicted after 1 hour of treatment of the current asthma exacerbation.
  • Women of child-bearing potential, unless surgically sterile (including tubal ligation) and/or at least 2 years post-menopausal, must have used 2 effective methods of avoiding pregnancy (including oral, transdermal, or implanted contraceptives, intrauterine device, female condom with spermicide, diaphragm with spermicide, cervical cap, abstinence, use of a condom with spermicide by the sexual partner, or sterile sexual partner) from screening through the end of the study (Study Day 84; Cessation of birth control after this point should be discussed with a responsible physician).
  • Men, unless surgically sterile, must likewise practice 2 effective methods of birth control (condom with spermicide or abstinence) and must use such precautions from Study Day 0 through Study Day 84.
  • Otherwise healthy by medical history and physical examination.
  • A chest x-ray that is normal for an asthmatic population and excludes alternative diagnosis per the investigation.
  • Ability to complete the follow-up period until Study Day 168 as required by protocol.
  • The investigator has determined that the subject is clinically stable and the FEV1, is greater than or equal to 30% predicted prior to receiving investigational product on Study Day 0.

Exclusion Criteria:

  • Known history of allergy or reaction to any component of the investigational product formulation.
  • Acute illness other than asthma at the start of the study.
  • Fever > 38.6°C (>101.5°F).
  • Current acute asthma attack is due to aspirin-induced asthma.
  • Current asthma episode is an anaphylactoid/anaphylactic reaction presenting with acute bronchospasm.
  • Evidence of clinically significant non-respiratory active infection, including ongoing chronic infection.
  • History or current prolonged diarrhea, abdominal pain, and/or blood and mucus in stools or have minor symptoms AND have exposure to stream or lake water, been exposed to someone who has a parasitic infection (like a family member), or study subject has traveled outside the US and/or Canada within the last year.
  • Use of immunosuppressive medication (except oral prednisone and inhaled and topical corticosteroids) within 30 days before randomization into the study.
  • Have received Xolair(TM)within 6 months before randomization into the study.
  • Receipt of immunoglobulin or blood products within 30 days before randomization into the study.
  • Receipt of any investigational drug therapy within 6 months before the first dose of investigational product in this study through Study Day 168.
  • History of primary immunodeficiency.
  • Previous medical history, or evidence, of an intercurrent illness that may compromise the safety of the subject in the study.
  • History of clinically significant abnormality on ECG in the opinion of the investigator.
  • Pregnancy (must have a negative serum pregnancy test prior to the first dose of investigational product).
  • Breastfeeding or lactating woman.
  • History of treatment for alcohol or drug abuse within the past year.
  • Diagnosis of COPD by a healthcare professional.
  • Evidence of any clinically significant systemic disease on physical examination.
  • History of cancer except basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy > 1 year prior to entry or other malignancies treated with apparent success with curative therapy > 5 years prior to entry.
  • Known exposure to inhaled occupational agents or fumes with an established diagnosis of occupational asthma.
  • Any condition (ie, impending ventilatory failure or hemodynamic compromise) that,in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of study results.
  • Any employee of the clinical study site who is involved with the conduct of the study.
  • History of cigarette smoking > 20 pack years.
  • Previously received MEDI-563.
  • Asthma exacerbation due to acute inhalational exposure.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00768079

Locations
United States, Florida
Research Site
Tampa, Florida, United States, 33613
United States, Massachusetts
Research Site
Boston, Massachusetts, United States
Baystate Emergency Medicine
Springfield, Massachusetts, United States, 01199
United States, Michigan
Henry Ford Hospital; Dept. of Emergency Medicine
Detroit, Michigan, United States, 48202
United States, New York
Nassau Univ. Medical Center
East Meadow, New York, United States, 11554
Long Island Jewish Medical Center, Dept. of Emergency Medicine
New Hyde Park, New York, United States, 11040-1496
Research Site
Stony Brook, New York, United States, 11794
United States, North Carolina
Research Site
Greenville, North Carolina, United States, 27834
United States, Ohio
Emergency Medicine Research Center- Summa Health System
Akron, Ohio, United States, 44309
Research Site
Cleveland, Ohio, United States, 44109
United States, Pennsylvania
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
United States, Rhode Island
Research Site
Providence, Rhode Island, United States, 02903
Canada, Alberta
Research Site
Edmonton, Alberta, Canada, T6G 2B7
Canada, Nova Scotia
Capital District Health Authority
Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Ontario
Research Site
Kingston, Ontario, Canada
Sponsors and Collaborators
MedImmune LLC
Investigators
Study Director: Joseph M. Parker, M.D. MedImmune LLC
  More Information

Additional Information:
No publications provided

Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT00768079     History of Changes
Other Study ID Numbers: MI-CP186
Study First Received: October 3, 2008
Last Updated: May 3, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on September 16, 2014