Blinded Safety & Efficacy Placebo Controlled Study of Icatibant for Angiotensin Converting Enzyme Inhibitor Induced Angioedema
Condition: Angiotensin Converting Enzyme Inhibitor Induced Angioedema
MeSH terms: Angioedema
Intervention: Icatibant; Placebo
Intervention description: Single dose of 30 mg icatibant administered within 12 hours of the onset of an acute attack of ACE-I-induced angioedema
Intervention MeSH terms: Icatibant
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 118.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: icatibant; Firazyr; ACE-I

Summary:

      This study is being conducted to compare the safety and efficacy of icatibant with placebo in
      the treatment for Angiotensin-Converting Enzyme Inhibitor (ACE-I)-Induced Angioedema in
      Adults.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female, 18 years of age or older.

          2. Patient is currently being treated with an ACE inhibitor.

          3. Patient presenting with an ACE inhibitor-induced angioedema attack of the head and/or
             neck region within 12 hours of onset (must be sufficiently less than 12 hours to allow
             study drug to be given with 12 hours of attack onset).

          4. Angioedema must be considered at least moderate in severity for at least one of the
             four angioedema-associated airway symptoms (difficulty breathing, difficulty
             swallowing, voice changes, tongue swelling).

          5. Patient must have voluntarily signed an Institutional Review Board/Independent Ethics
             Committee-approved informed consent form after all relevant aspects of the study have
             been explained and discussed with the patient.

          6. Females must have a negative urine pregnancy test prior to administration of the study
             medication, with the exception of those females who have had a total hysterectomy or
             bilateral oophorectomy, or who are 2 years post-menopausal.

        Exclusion Criteria:

          1. Patient has a diagnosis of angioedema of other etiology (eg, hereditary or acquired
             angioedema, allergic angioedema [eg, food, insect bite or sting, evident clinical
             response to antihistamines and/or corticosteroids], anaphylaxis, trauma, abscess or
             infection or associated disease, local inflammation, local tumor, post-operative or
             post-radiogenic edema, salivary gland disorders, other [non-ACE inhibitor]
             drug-induced angioedema).

          2. Patients with a family history of recurrent angioedema.

          3. Patients who have had a previous episode(s) of angioedema while not on ACE inhibitor
             therapy.

          4. Patients with acute urticaria (itchy, erythematous wheals).

          5. Patients who have an intervention to support the airway (eg, intubation, tracheotomy,
             cricothyrotomy) due to the current attack of angioedema.

          6. Patient has any of the following vascular conditions that, in the judgment of the
             investigator, would be a contraindication to participation in the study.

               -  Unstable angina pectoris or acute myocardial ischemia

               -  Hypertensive urgency or emergency (diastolic blood pressure [DBP] >120 mm Hg or
                  systolic blood pressure [SBP] >180 mm Hg)

               -  Within 1 month of a stroke or transient ischemic attack

               -  New York Heart Association (NYHA) heart failure class IV

          7. Patient has a serious or acute condition or illness that, in the judgment of the
             investigator, would interfere with evaluating the safety and/or efficacy assessments
             of the study (eg, a condition or illness requiring hemodialysis).

          8. Patient is pregnant or breast feeding.

          9. Patient has participated in another investigational study in the past 30 days.

         10. Patient is unable to understand the nature, scope, and possible consequences of the
             protocol, or is unlikely or unable to comply with the protocol assessments, or is
             unlikely to complete the study for any reason.

         11. Patients who are not suitable for the study in the opinion of the investigator.

         12. Patient has experienced hypersensitivity to the active substance of the
             investigational product or to any of its excipients.