Deposition of Inhaled Prolastin in Cystic Fibrosis Patients

Phase 2 Completed 72 enrolled Grifols Therapeutics LLC

RandomizedParallel-groupOpen-labelTreatment

Summary

The objective of this trial is to determine the optimal region of the lung for depositing Prolastin (alpha-1 antitrypsin; AAT) by inhalation in order to treat cystic fibrosis (CF). The AKITA® nebulizer has settings which can be varied to target the inhaled drug to either the deep lung or to the upper airways in a one to one randomization. The study will measure how much of the activity of the enzyme elastase is inhibited by AAT.

Timeline

Start: 2003-12
Primary completion: 2004-06
Completion: 2004-06

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Peripheral Deposition vs Bronchial Deposition; p = 0.197; ANCOVA NCT00486837 ↗

Publications

Results Griese M, Latzin P, Kappler M, Weckerle K, Heinzlmaier T, Bernhardt T, Hartl D. alpha1-Antitrypsin inhalation reduces airway inflammation in cystic fibrosis patients. Eur Respir J. 2007 Feb;29(2):240-50. doi: 10.1183/09031936.00047306. Epub 2006 Oct 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Alpha 1-Antitrypsin	Protein / enzyme biologic	25 mg	Inhaled