Sputum studies of inhaled aerolisedα1-antitrypsin# (α1-AT) in patients with cystic fibrosis (CF) and healthy volunteers
| Subjects n | Nebuliser | α1-AT aerosol | Sample | Elastase μg·mL−1 | α1-AT μg·mL−1 | [Ref.] | |||||
| Dose in nebuliser mg | DD to lungs¶ mg (% dose) | Type | Time after last inhalation h | Before | After | Before | After | ||||
| CF | 52 | AKITA with Pari LC Plus or LC Star | 25 q.d. | 25 (100)+ | IS | 16 | 30.2±3.7 | 28.6±4.8 | 17.1±2.9 | 30.3±5.5 | 94 |
| CF | 39 | Pari LC Star | 125–500 q.d. for 4 weeks | Placebo | S, SP | 24 | 2.6±3.8 | NG | NG | 133 | |
| 25 (20) | 0.8±1.7 | p = 0.21 | |||||||||
| 50 (20) | 2.8±4.9 | p = 0.09 | |||||||||
| 100 (20) | 0.7±1.9 | p = 0.31 | |||||||||
| CF | 17 | Pari LC Plus | 250 b.i.d. for 10 days | 50 (20) | S, SP | 12 | 156±27§ | 150±36ƒ | 124.8±20.8## | 421.2±98.8¶¶ | 139 |
AKITA is manufactured by Inamed, Gemünden, Germany. Pari LC Plus and Pari LC Star are manufactured by Pari, Starnberg, Germany. DD: delivered dose; IS: induced sputum; S: sputum; SP: sol phase; NG: not given; AKITA: electronically regulated device for the controlled inhalation of therapeutic aerosols. #: prolastin; ¶: per inhalation; +: AKITA used so as to guarantee deposition of 25 mg α1-AT in the lungs; §: conversion from 5.2±0.9 μM given in original; ƒ: conversion from 5.0±1.2 μM given in original; ##: conversion from 2.4±0.4 μM given in original; ¶¶: conversion from 8.1±1.9 μM given in original. 1 μM = 52 μg·mL−1 and 1 mg = 0.019 μmol α1-AT; 1 μM = 30 μg·mL−1 and 1 mg = 0.033 μmol human leukocyte elastase (assuming all enzyme is active).