This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

A Phase 2A Study to Evaluate the Safety and Effect on Exercise Challenge Testing of MEDI-528 in Adults With Asthma

This study has been terminated.
(Study is replaced by MI-CP198 per CPM.)
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00590720
First received: December 26, 2007
Last updated: February 4, 2014
Last verified: February 2014
  Purpose
The main objective of this study is to evaluate the safety and tolerability of multiple fixed doses of MEDI-528 in adult patients with stable asthma and exercise-induced bronchoconstriction (EIB).

Condition Intervention Phase
Asthma Biological: MEDI528 50 mg Other: PLACEBO Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2A, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety and Effect on Exercise Challenge Testing of Multiple Fixed Subcutaneous Doses of MEDI-528, A Humanized Anti-Interleukin-9 Monoclonal Antibody, in Adults With Stable Asthma and Exercise-Induced Bronchoconstriction

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • Incidence of Adverse Events [ Time Frame: Days 0 - 150 ]
    Number of participants experiencing adverse events (includes both adverse events and serious adverse events)

  • Incidence of Serious Adverse Events [ Time Frame: Days 0 - 150 ]
    Number of participants experiencing serious adverse events


Secondary Outcome Measures:
  • Incidence of Anti-drug Antibodies (ADA) to MEDI-528 [ Time Frame: Days 0, 28, 56, 119, and 150 ]
    Number of participants with ADA to MEDI-528

  • Absolute Maximum Change in Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Day 28 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise) ]
    The clinical activity of MEDI-528 on exercise-induced bronchoconstriction was measured by exercise challenge testing expressed as the maximum change in FEV1 measured before and after exercising on Day 28.

  • Absolute Maximum Change in Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Day 56 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise) ]
    The clinical activity of MEDI-528 on exercise-induced bronchoconstriction was measured by exercise challenge testing expressed as the maximum change in FEV1 before and after exercise on Day 56.

  • Absolute Maximum Change in Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Day 150 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise) ]
    The clinical activity of MEDI-528 on exercise-induced bronchoconstriction was measured by exercise challenge testing expressed as the maximum change in FEV1 before and after exercise on Day 150.

  • Percent Maximum Change in Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Day 28 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise) ]
    The clinical activity of MEDI-528 on exercise-induced bronchoconstriction was measured by exercise challenge testing expressed as the percent maximum change in FEV1 before and after exercise on Day 28.

  • Percent Maximum Change in Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Day 56 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise) ]
    The clinical activity of MEDI-528 on exercise-induced bronchoconstriction was measured by exercise challenge testing expressed as the percent maximum change in FEV1 before and after exercise on Day 56.

  • Percent Maximum Change in Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Day 150 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise) ]
    The clinical activity of MEDI-528 on exercise-induced bronchoconstriction was measured by exercise challenge testing expressed as the percent maximum change in FEV1 before and after exercise on Day 150.

  • Area Under the Curve (AUC) of Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Day 28 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise) ]
    AUC of FEV1 at Day 28

  • Area Under the Curve (AUC) of Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Day 56 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise) ]
    AUC of FEV1 at Day 56

  • Area Under the Curve (AUC) of Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Day 150 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise) ]
    AUC of FEV1 at Day 150

  • Time to Return in Minutes to 90 Percent of Baseline Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Day 28 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise) ]
    Time to return in minutes to 90 percent of baseline FEV1 (prior to exercise) after 30 minues of exercise on Day 28

  • Time to Return in Minutes to 90 Percent of Baseline Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Day 56 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise) ]
    Time to return in minutes to 90 percent of baseline FEV1 (prior to exercise) after exercise on Day 56

  • Time to Return in Minutes to 90 Percent of Baseline Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Day 150 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise) ]
    Time to return in minutes to 90 percent of baseline FEV1 (prior to exercise) after exercise on Day 150

  • Mean Trough Concentration (Cmin) [ Time Frame: Days 0, 3, 7, 10, 14, 17, 21, 24, 28, 32, 37, 42, 56, 70, 84, 119, and 150 ]
    Cmin of MEDI-528

  • Mean Trough Concentration at Last Measurable Time Point (Cmin_last) [ Time Frame: Days 0, 3, 7, 10, 14, 17, 21, 24, 28, 32, 37, 42, 56, 70, 84, 119, and 150 ]
    Cmin_last of MEDI-528

  • Half-life (T1/2) [ Time Frame: Days 0, 3, 7, 10, 14, 17, 21, 24, 28, 32, 37, 42, 56, 70, 84, 119, and 150 ]
    T1/2 of MEDI-528

  • Accumulation Index [ Time Frame: Days 0 and 24 ]
    Ratio of trough concentrations after first (Day 0) and last (Day 24) dose of MEDI-528


Enrollment: 11
Study Start Date: March 2008
Study Completion Date: October 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MEDI528 50 mg
MEDI-528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
Biological: MEDI528 50 mg
MEDI-528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
Placebo Comparator: PLACEBO
Placebo administered as a subcutaneous injection twice weekly for 4 weeks
Other: PLACEBO
Placebo administered as a subcutaneous injection twice weekly for 4 weeks

Detailed Description:
The primary objective of this study is to evaluate the safety and tolerability of multiple fixed escalating SC doses of MEDI-528 in adult patients with stable asthma and exercise-induced bronchoconstriction (EIB).
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients must meet all of the following criteria:

  • Male or female adults, age 18 through 50 years at the time of screening;
  • Weight 50-100 kg and body mass index ≤ 35;
  • Written informed consent obtained from the patient prior to receipt of any study medication or beginning study procedures;
  • Documented clinical history of asthma and receiving stable treatment for ≥ 1 month prior to Study Day 0;
  • Airway hyperresponsiveness (AHR) on methacholine inhalation challenge testing at screening (or a documented history within the past 6 months), with provoking concentration of methacholine to cause a 20% fall in FEV1(subscript) (PC20) ≤ 8 mg/mL (Crapo, 2000);
  • Exercise-induced bronchoconstriction (EIB) with a decrease in FEV1 (subscript) of ≥ 15% from pre-exercise challenge testing level at screening;
  • Able to provide spirometry readings that meet American Thoracic Society (ATS) and European Respiratory Society (ERS) standards (Miller, 2005);
  • Women of childbearing potential, unless surgically sterile or at least 1 year post-menopausal, must use two effective methods of avoiding pregnancy (including oral, transdermal, or implanted contraceptives, intrauterine device, female condom, spermicide, diaphragm, cervical cap, abstinence, contraceptive foam, or use of a condom by the sexual partner or sterile sexual partner) from screening through Study Day 0, and must agree to continue using such precautions through Study Day 150. Cessation of birth control after this point should be discussed with a responsible physician. Men, unless surgically sterile, must likewise use an effective method of birth control (condom with spermicide) and must agree to continue using such precautions from screening through Study Day 150;
  • Able to complete the study period, including follow-up period, of up to approximately 150 days; and
  • Willing to forego other forms of experimental treatment and study procedures during the study and for 30 days after the follow-up period is completed.

Exclusion Criteria:

Patients must have none of the following criteria:

  • Receipt of MEDI-528 in any previous clinical study;
  • History of allergy or reaction to any component of the study drug formulation;
  • Lung disease other than asthma (eg, chronic obstructive pulmonary disease, cystic fibrosis);
  • Forced expiratory volume in 1 second (FEV1-subscript) < 70% of predicted values at screening;
  • Use of systemic immunosuppressive drugs including systemic corticosteroids, ICS with doses > 800 μg/day budesonide (or another ICS of equivalent dose), long-acting β2 agonists, cromolyn sodium, nedocromil sodium, leukotriene receptor antagonists, theophylline, or omalizumab from screening through Study Day 150;
  • Current use of any β-adrenergic antagonist (eg, propranolol);
  • Any disease or illness, other than asthma, that is likely to require the use of systemic corticosteroids during the study period;
  • Acute illnesses or evidence of significant active infection, such as fever ≥ 38.0°C (100.5°F) from screening through Study Day 0;
  • Current allergy vaccination therapy (desensitization immunotherapy);
  • Receipt of any investigational drug therapy within 30 days or any biologic(s) within 5 half-lives of the agent prior to screening;
  • Pregnancy (women of child bearing potential, unless surgically sterile or at least 1 year postmenopausal, must have a negative serum and urine pregnancy test at screening before methacholine inhalation challenge testing and a negative urine pregnancy test prior to study drug administration on Study Day 0);
  • Breastfeeding or lactating woman;
  • Evidence of infection with hepatitis B or C virus or HIV-1 or HIV-2, or active infection with hepatitis A; must have negative HIV-1, HIV-2, hepatitis A, B, and C tests at screening;
  • History of cancer other than basal cell carcinoma of the skin or cervical carcinoma-in-situ treated with apparent success with curative therapy more than 1 year prior to Study Day 0;
  • History of primary immunodeficiency
  • History of pancreatitis or currently active gastroduodenal ulcer;
  • Current use of tobacco products or a history of use of tobacco products of more than one cigarette per month or equivalent within 1 year prior to randomization or history of smoking of ≥ 10 pack-years;
  • History of life-long urinary retention;
  • History of anaphylaxis (defined as immediate life-threatening event requiring medical invention);
  • Elective surgery planned from screening through Study Day 150;
  • Clinically significant abnormality, as determined by the investigator, on 12-lead ECG or chest radiograph at screening;
  • History of any disease, evidence of any current disease (other than asthma), any finding upon physical examination, or any laboratory abnormality, that, in the opinion of the investigator or medical monitor, may compromise the safety of the patient in the study or confound the analysis of the study; or
  • Any employee of the research site who is involved with the conduct of the study.
  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: NCT00590720

Locations
United States, California
Institute of Healthcare Assessment, Inc
San Diego, California, United States, 92120
United States, Colorado
National Jewish Medical and Research Center
Denver, Colorado, United States, 80206
United States, Connecticut
Waterbury Pulmonary Associates
Waterbury, Connecticut, United States, 06708
United States, Florida
Univ. of South Florida, Asthma, Allergy & Immunology Clinical Research Unit
Tampa, Florida, United States, 33613
United States, Illinois
Sneeze,Wheeze & Itch Associates, LLC
Normal, Illinois, United States, 61761
United States, Massachusetts
Northeast Medical Research Associates, Inc
No. Dartmouth, Massachusetts, United States, 02747
United States, Missouri
The Clinical Research Center, LLC
St. Louis, Missouri, United States, 63141
United States, Nebraska
Creighton University
Omaha, Nebraska, United States, 68131
United States, Ohio
Bernstein Clinical Research Center
Cincinnati, Ohio, United States, 45231
Canada, Alberta
Calgary COPD & Asthma Program
Calgary, Alberta, Canada, T2N4N1
Canada, Ontario
UHN- Toronto Western Hospital
Toronto, Ontario, Canada, M5T2S8
Canada, Quebec
Centre de Recherche Appliquee en Allergie de Quebec
Quebec City, Quebec, Canada, G1V4M6
Sponsors and Collaborators
MedImmune LLC
Investigators
Study Director: Joseph Parker, M.D. MedImmune LLC
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT00590720     History of Changes
Other Study ID Numbers: MI-CP143
Study First Received: December 26, 2007
Results First Received: October 22, 2013
Last Updated: February 4, 2014

Keywords provided by MedImmune LLC:
Asthma
Bronchitis

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 June 23, 2017