NCT00499837

Phase II Study of the Safety and Efficacy of Inhaled Alpha-1 Antitrypsin (AAT ) in Cystic Fibrosis Patients

Double-Blind, Randomized, Placebo-Controlled, Phase II Study of the Safety and Efficacy of Inhaled Alpha-1 Antitrypsin (AAT ) in Cystic Fibrosis Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Kamada, Ltd. · Industry
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

Summary

Cystic Fibrosis (CF) is an inherited disorder in which mucus-secreting glands in the lungs produce considerable quantity of thick, sticky secretions that clog the airways, promote bacterial growth and lead to chronic obstruction, inflammation and destruction of the airways. The purpose of this study is to collect data about the resolution of the chronic inflammatory state in addition to assure the safety of the therapy in CF patients.

Detailed description

In CF patients the unregulated inflammatory response overwhelms the normal protease (elastase)/antiprotease (AAT) balance, leading to the accumulation of elastase in the lung, destruction of the lung architecture, severe pulmonary dysfunction, and ultimately death. Administration of AAT is to address the elastase/antiprotease imbalance in order to prevent destruction of the lung tissue and reduce the inflammatory dysregulation that causes pulmonary dysfunction.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	Aerosolized, human, plasma-derived Alpha-1 Antitrypsin

Timeline

• Start date: 2007-09-01
• Primary completion: 2008-07-01
• Completion: 2008-07-01
• First posted: 2007-07-12
• Last updated: 2016-06-09

Locations

1 site across 1 country: Israel