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A Study to Evaluate the Efficacy of MEDI-528 on Late Asthmatic Response With Atopic Asthma
This study has been completed.
First Received: October 31, 2006   Last Updated: August 12, 2008   History of Changes
Sponsored by: MedImmune LLC
Information provided by: MedImmune LLC
ClinicalTrials.gov Identifier: NCT00394654
  Purpose

This is a Phase 2a, randomized multicenter study to evaluate the efficacy of MEDI-528 on LAR in adult patients with atopic asthma.


Condition Intervention Phase
Asthma
Biological: MEDI-528
Other: Placebo
Phase II

MedlinePlus related topics: Asthma
Drug Information available for: MEDI 528
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title: A Phase2A, Randomized, Multicenter Study to Evaluate the Efficacy of MEDI-528 a Humanized Anti-Interleukin-9 Monoclonal Anti-Body, on Late Asthmatic Response (LAR) Induced By Allergen Inhalation In Adults With Atopic Asthma

Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • The primary endpoint of the study is the change from baseline in mean maximum decline of FEV1 during LAR at 3 to 7 hours after an inhaled allergen challenge [ Time Frame: Prior to drug and three times post drug ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The safety of IV MEDI-528 will be summarized by descriptive statistics [ Time Frame: First baseline visit study day 126 ] [ Designated as safety issue: Yes ]
  • Single dose PK parameters such as peak concentration (Cmax), time to peak concentration of MEDI-528 in serum will be estimated using noncompartmental analysis [ Time Frame: Study day 126 ] [ Designated as safety issue: No ]
  • Exploratory endpoints will investigate the effects of MEDI-528 on the following physiological consequences of allergen inhalation challenge, other than LAR inhibition, that may be relevant to the pathogenesis of asthma [ Time Frame: Baseline study day 126 ] [ Designated as safety issue: No ]
  • EAR [ Time Frame: Baseline two months post dose ] [ Designated as safety issue: Yes ]
  • Airway inflammation [ Time Frame: Baseline two months post dose ] [ Designated as safety issue: Yes ]
  • Bronchoconstriction [ Time Frame: Baseline two months post dose ] [ Designated as safety issue: Yes ]
  • AHR [ Time Frame: Baseline two months post dose ] [ Designated as safety issue: Yes ]
  • Free and MEDI-528-bound IL-9 levels in sputum supernatant and nasal lavage fluids. [ Time Frame: Baseline two months post dose ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: November 2006
Study Completion Date: December 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
MEDI-528
Biological: MEDI-528
MEDI-528 (9.0 mg/kg) as a single IV infusion
2: Placebo Comparator
Placebo
Other: Placebo
Placebo as a single IV infusion

Detailed Description:

This study (MI-CP138) is a Phase 2a, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy of MEDI-528 on LAR in adult patients with atopic asthma. Approximately three investigative sites in Canada will participate in this study, with up to 40 evaluable patients randomized in a 1:1 ratio to receive MEDI-528 (9.0 mg/kg) or placebo as a single IV infusion.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female adults, age 18 through 65 years of age at the time of screening;
  • Written informed consent obtained from the patient prior to receipt of any study medication or beginning study procedures;
  • Previously documented diagnosis of asthma of > 1 year duration, based on episodic symptoms of airflow obstruction, at least partial reversibility of airflow obstruction, with alternative diagnoses (e.g., chronic obstructive pulmonary disease) ruled out;
  • AHR in the methacholine challenge test with a PC20 (provoking concentration of methacholine to cause a 20% fall in FEV1) ≤ 16 mg/mL (Crapo, 2000);
  • Have dual response of EAR, defined as a decrease in FEV1 ≥ 20% at 0 to 3 hours after inhalation, and LAR, defined as a decrease in FEV1 ≥ 15% 3 to 7 hours after inhalation, to inhaled allergen;
  • Asthma symptoms are adequately controlled on short-acting β2 agonists (e.g., albuterol) alone;
  • Have had no significant changes in regular asthma medications and no acute asthma exacerbations requiring corticosteroid rescue, hospitalization, or emergency department visits for at least 4 weeks prior to screening and up through the time of the first dose of study drug on Study Day 0.
  • Sexually active women, unless surgically sterile or at least 1 year post-menopausal, must have used an effective method of avoiding pregnancy (including oral or implanted contraceptives, intrauterine device, female condom, diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual partner) for 21 days prior to the first dose of study drug on Study Day 0, and must agree to continue using such precautions through Study Day 126. Cessation of birth control after this point should be discussed with a responsible physician. Sexually active men, unless surgically sterile, must likewise use an effective method of birth control (condom) and must agree to continue using such precautions through Study Day 126;
  • Able to complete the follow-up period through Study Day 126, as required by the protocol.
  • Willing to forego other forms of experimental treatment and study procedures during the study; and
  • Able to provide spirometric readings that meet American Thoracic Society (ATS) standards (ATS, 1995).

Exclusion Criteria:

  • Receipt of MEDI-528 in any previous clinical study;
  • History of allergy or adverse reactions to any component of the MEDI-528 formulation;
  • Lung disease other than allergic asthma (e.g. chronic bronchitis);
  • Current use of any systemic or inhaled immunosuppressive drugs, including systemic and inhaled corticosteroids (topical corticosteroids are permitted), long-acting b2 agonists, leukotriene antagonists, cromolyn sodium, nedocromil sodium, theophylline or any inhaled or systemic medication for asthma other than short-acting b2 agonists, for at least 4 weeks prior to study drug administration on Study Day 0.
  • Current use of any b-adrenergic antagonist (e.g. propranolol).
  • Any disease or illness, other than asthma, that may require the use of systemic corticosteroids during the study period.
  • Acute illnesses or evidence of clinically significant active infection, such as fever ³ 38.0°C (100.5°F) at screening and through the time of the study drug administration on Study Day 0;
  • Current allergy-vaccination therapy (i.e., desensitization immunotherapy) with less than 3 months of stable maintenance doses prior to the baseline allergen inhalation challenge;
  • Receipt of any investigational drug therapy within 30 days or any biologic(s) within 5 half-lives of the agent prior to the first dose of study drug through Study Day 150;
  • Receipt of any therapy with a leukocyte-depleting agent unless recovery in white cell count has been documented before screening;
  • Pregnancy (sexually active females must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to study drug administration on Study Day 0);
  • Is a nursing mother at the time of study enrollment;
  • Evidence of infection with hepatitis B or C virus, or HIV-1 or HIV-2, or active infection with hepatitis A;
  • History of significant systemic disease (e.g., cancer; infection; coronary artery disease or other cardiovascular disease; or hematological, renal, hepatic, endocrinologic, neurologic, rheumatologic, or gastrointestinal disease);
  • History of cancer other than nonmelanoma skin cancer or cervical carcinoma-in-situ that have been treated successfully with curative therapy;
  • History of primary immunodeficiency;
  • History of pancreatitis;
  • History of use of tobacco products within 2 years of baseline or history of smoking >= 10 pack-years;
  • Elective surgery planned from the time of screening through Study Day 126;
  • Clinically significant abnormalities (other than asthma) upon physical examination prior to study drug administration on Study Day 0;
  • Clinically significant abnormality, as determined by the investigator, on 12-lead ECG or chest radiograph at the time of screening;
  • At the time of screening, any of the following abnormalities: aspartate transaminase (AST), alanine transaminase (ALT), or amylase > 1.5 × above the upper limits of normal (ULN); or serum creatinine > 1.3 × ULN; or any other abnormal laboratory values in the screening panel that, in the opinion of the principal investigator (PI), are judged to be clinically significant; or
  • Evidence of any systemic disease or respiratory disease (other than asthma), any finding upon physical examination or history of any disease that, in the opinion of the PI or medical monitor, may compromise the safety of the patient in the study or confound the analysis of the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00394654

Locations
Canada
Hopital Laval
Quebec, Canada, G1V 4G5
Canada, Ontario
McMaster University
Hamilton, Ontario, Canada, L8N 3Z5
Canada, Saskatchewan
University of Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N 0W8
Sponsors and Collaborators
MedImmune LLC
Investigators
Study Director: Nestor Molfino, M.D. MedImmune LLC
  More Information

No publications provided

Responsible Party: MedImmune ( Nestor Molfino, M.D. )
Study ID Numbers: MI-CP138
Study First Received: October 31, 2006
Last Updated: August 12, 2008
ClinicalTrials.gov Identifier: NCT00394654     History of Changes
Health Authority: Canada: Health Canada

Study placed in the following topic categories:
Antibodies, Monoclonal
Antibodies
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Bronchial Diseases
Lung Diseases
Hypersensitivity, Immediate
Asthma
Immunoglobulins
Respiratory Hypersensitivity

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

ClinicalTrials.gov processed this record on May 07, 2009