Advertisement

Topics

AMelioration of Angiotensin Converting Enzyme Inhibitor Induced Angioedema Study

2014-08-27 03:12:31 | BioPortfolio

Summary

This is a multicenter study recruiting patients with angioedema induced by ACEI.

Open-label treatment with subcutaneous Icatibant compared to a historic group of 47 patients with ACE inhibitor induced angioedema which the investigators have been previously treated in the investigators centers with current "standard" therapy (250 mg methylprednisolon and 2 mg clemastine).

In cases with fast progression of edema after application the study-drug, a second application with icatibant could be necessary. Rescue medication and intervention.

Description

Sudden occurrence of subcutaneous or submucosal non-itchy swelling, so-called angioedema, is a well known side effect of angiotensin-converting enzyme inhibitors (ACEi), which may become life-threatening if the upper airway is involved. To be note, ACEi induced angioedema were always located in the head and neck region.

The pathophysiology of ACE inhibitor (ACEi) induced angioedema most likely resembles that of hereditary angioedema (HAE), i.e. it is mainly mediated by bradykinin induced activation of vascular bradykinin B2 receptors (BKR-2). In contrast to an increased bradykinin generation in HAE, treatment with ACEi decreases the bradykinin degradation in plasma and increases the biological activity of bradykinin.

The current pharmacotherapy of ACEi induced angioedema is not satisfactory. Antihistamines and corticosteroids may be effective in the treatment of urticaria with cutaneous edema and itchy, but are theoretically ineffective and hence superfluous in bradykinin induced angioedema. However, glucocorticoids still belong to the standard treatment of angioedema.

We hypothesized that the BKR-2 antagonist icatibant might be an effective therapy for ACEi-induced angioedema.

Patients with ACEi induced angioedema, located in the upper aero-digestive tract will be randomized and treated either with icatibant and plazebo or cortisone with clemastin and plazebo.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Angioedema

Intervention

Icatibant (subcutaneous) and plazebo (intravenous), Cortisone + Clemastin (intravenous) and plazebo (subcutaneous)

Location

Klinikum rechts der Isar Hals-Nasen-Ohrenklinik der TUM
Munich
Bavaria
Germany
81675

Status

Not yet recruiting

Source

Technische Universität München

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:31-0400

Clinical Trials [2910 Associated Clinical Trials listed on BioPortfolio]

A First-In-Human Study With a Single Dose UCB7665 in Healthy Volunteers

This study is designed to evaluate the safety and tolerability of single ascending doses of UCB7665 administered by intravenous or subcutaneous infusion in healthy subjects.

EASSI - Evaluation of the Safety of Self-Administration With Icatibant

This study is being conducted to explore the clinical safety, local tolerability, convenience and effectiveness of self-treatment of hereditary angioedema (HAE) attacks with subcutaneous i...

Subcutaneous vs Intravenous Hydration on Older Adults

This study will evaluate the risk of adverse effects of intravenous hydration compared to subcutaneous hydration. Half of the patients will receive hydration by the subcutaneous route the ...

Efficacy and Safety Study of Intra-Articular Multiple Doses of Icatibant in Patients With Painful Knee Osteoarthritis

The primary objective is to compare the overall treatment effect on pain relief between icatibant and placebo. The secondary objectives are to assess the efficacy of icatibant in term of o...

Study of Subcutaneous Versus Intravenous Administration of Bortezomib in Patients With Multiple Myeloma in China

Intravenous injection is the standard administration route of bortezomib; however, subcutaneous administration is an important alternative. We want to compared the pharmacokinetic of subcu...

PubMed Articles [1707 Associated PubMed Articles listed on BioPortfolio]

Subcutaneous rather than intravenous ustekinumab induction is associated with comparable circulating drug levels and early clinical response: A pilot study.

Ustekinumab (USK) is licenced for intravenous induction and subcutaneous (S/C) maintenance in Crohn's disease.

Subcutaneous or intravenous opioid administration by patient-controlled analgesia in cancer pain: a systematic literature review.

Opioids administered by various routes are a mainstay of tumour-related pain management. Subcutaneous or intravenous patient-controlled analgesia (PCA) with opioids is an appropriate and safe form of ...

The Extended Dwell Peripheral Intravenous Catheter Is an Alternative Method of NICU Intravenous Access.

Establishing vascular access is a common neonatal intensive care unit procedure. The extended dwell peripheral intravenous (EPIV) catheter is a 6-cm and 8-cm silicone catheter for peripheral vein inse...

Dose determination of sufentanil for intravenous patient-controlled analgesia with background infusion in abdominal surgeries: A random study.

Sufentanil has been widely used in epidural PCA, while its use in intravenous PCA has rarely been reported. Based on its use in target controlled infusion, we reckoned that the effect-site concentrati...

Analysis of related factors of orolingual angioedema after rt-PA intravenous thrombolytic therapy.

Orolingual angioedema (OA) is a rare clinical complication with a potentially fatal risk that occurs after the intravenous application of alteplase (rt-PA) in patients with acute ischemic stroke. The ...

Medical and Biotech [MESH] Definitions

Immunoglobulin preparations used in intravenous infusion, containing primarily IMMUNOGLOBULIN G. They are used to treat a variety of diseases associated with decreased or abnormal immunoglobulin levels including pediatric AIDS; primary HYPERGAMMAGLOBULINEMIA; SCID; CYTOMEGALOVIRUS infections in transplant recipients, LYMPHOCYTIC LEUKEMIA, CHRONIC; Kawasaki syndrome, infection in neonates, and IDIOPATHIC THROMBOCYTOPENIC PURPURA.

Hemorrhagic necrosis that was first demonstrated in rabbits with a two-step reaction, an initial local (intradermal) or general (intravenous) injection of a priming endotoxin (ENDOTOXINS) followed by a second intravenous endotoxin injection (provoking agent) 24 h later. The acute inflammation damages the small blood vessels. The following intravascular coagulation leads to capillary and venous THROMBOSIS and NECROSIS. Shwartzman phenomenon can also occur in other species with a single injection of a provoking agent, and during infections or pregnancy. Its susceptibility depends on the status of IMMUNE SYSTEM, coagulation, FIBRINOLYSIS, and blood flow.

Delivery of substances through VENIPUNCTURE into the VEINS.

An imidazole antifungal agent that is used topically and by intravenous infusion.

An intravenous anesthetic with a short duration of action that may be used for induction of anesthesia.

More From BioPortfolio on "AMelioration of Angiotensin Converting Enzyme Inhibitor Induced Angioedema Study"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Drug Discovery
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...

Pharmacy
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...


Searches Linking to this Trial