[There are difficulties in controlling inhalation of inhale ATT probably due to heterogeneous breathing patterns of the patients. Method were improved as shown In this paper from 2003 (PARI's device was also tested) but efficacy is still a problem. And there's the threat from Arriva Pharmaceuticals which develop a nebulized formulation of rAAT (they are also developing a gel formulation), currently undergoing phase II.]
Peripheral deposition of alpha1-protease inhibitor using commercial inhalation devices.
Eur Respir J. 2003 Aug;22(2):263-7
Brand P, Beckmann H, Maas Enriquez M, Meyer T, Müllinger B, Sommerer K, Weber N, Weuthen T, Scheuch G.
Clinical Research Group Aerosols in Medicine of the GSF-Institute for Inhalation Biology and the Asklepios Clinic for Respiratory Medicine, Gauting, Germany. brand@inamed.de
Patients with hereditary alpha1-proteinase inhibitor (alpha1-PI) deficiency are at risk of developing lung emphysema. To prevent the development of this disease, alpha1-PI replacement therapy via inhalation may be a more convenient and effective therapy than the intravenous administration of the drug. In order to optimise this treatment approach, lung deposition of inhaled radiolabelled alpha1-PI (Prolastin) was studied using four different commercial inhalation devices (PARI-LC Star, HaloLite, and AKITA system in combination with LC Star and Sidestream) in six patients with alpha1-PI deficiency and mild-to-severe chronic obstructive pulmonary disease. The time required to deposit 50 mg of the Prolastin (5% solution) in the lung periphery was used as a measure for the efficiency of delivery. The time was calculated from measurements of total and peripheral lung deposition of the radiolabelled alpha1-PI. This time was shortest for the AKITA system (18-24 min) and significantly higher for the PARI-LC Star (44 min) and the HaloLite (100 min). The higher efficiency of drug delivery using the AKITA system is due to the fact that this device controls breathing patterns, which are optimised for each patient individually.
