View Clinical Trial (Medical Research Study)
A Phase 2 Study to Evaluate the Safety and Efficacy of Intravenously Administered MEDI-563 - NCT00768079-01199(Clinical Trial 470544)
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| City: |
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Springfield |
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State:
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MA |
| Zip Code: |
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01199 |
| Conditions: |
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Asthma |
| Purpose: |
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The study will evaluate the effect of two IV dose regimens of MEDI-563 on the asthma
exacerbation rate in adults who required an urgent healthcare visit for treatment of an
acute asthma exacerbation.
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| Study summary: |
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The study will evaluate the effect of two IV dose regimens of MEDI-563 (0.3 and 1.0 mg/kg)
on the asthma exacerbation rate (relapse and de novo) in adult subjects who required an
urgent healthcare visit for treatment of an acute asthma exacerbation. |
| Criteria: |
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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. |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 11, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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