cameo

Dear Colleague,

As a health care professional, you know that clinical research studies are necessary to discover new and more effective treatments for patients.

We’d like to inform you about the new CAMEO clinical research study (Protocol HGT-FIR-096) for patients with ACE-inhibitor (ACE-I)-induced angioedema, as it may be an option for some of your patients.

The primary aim of the study is to demonstrate that icatibant (Firazyr) is significantly more effective than placebo in resolving attacks of angioedema caused by ACE-I use based on assessment of protocol-defined upper airway symptoms.

Icatibant is a bradykinin B2 receptor antagonist indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults. Icatibant is currently marketed as Firazyr® for treatment of HAE attacks but is not approved to treat ACE-I-induced angioedema.

Key Eligibility Criteria:

  • 18 years of age or older
  • Currently being treated with an ACE-I
  • Presenting with an ACE-I-induced angioedema attack of the head and/or neck region within 12 hours of onset
  • Moderate angioedema for at least one of four airway symptoms (difficulty breathing, difficulty swallowing, voice changes, tongue swelling)
  • Not pregnant or breastfeeding
  • Patient has no diagnosis of angioedema of other etiology (e.g., hereditary, acquired, or allergic angioedema)
  • No family history of recurrent angioedema
  • No previous episode of angioedema while not on ACE-I therapy
  • No acute urticaria (itchy, erythematous wheals)
  • No intervention to support the airway (e.g., intubation, tracheotomy, cricothyrotomy) during the current attack of angioedema

Eligible subjects will be randomized at a 1:1 ratio to receive a single injection of either icatibant or placebo within 12 hours of symptom onset. Patients who do not qualify for the study may be given conventional treatment, if needed. All patients will then be referred back to you for any non-study related care.

We invite you to refer any patients who may be eligible for the CAMEO study. Please share this email with other providers who may have eligible patients. For more information about the study, visit the sponsor’s website or clinicaltrials.gov (ClinicalTrials.gov Identifier: NCT01919801).

Please contact the site coordinator/s listed below with any referrals or questions:

Institution: Texas General Hospital
Investigator: Jane Smith,  M.D.
Coordinator:  Nancy Jones, R.N.
Email:  Njones@texashospital.com
Phone: xxx-xxx-xxxx

Thank you for your consideration.

Sincerely,

CAMEO Study Team