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The objective of this trial was to determine the optimal region of the lung for depositing Prolastin (Alpha1-Proteinase Inhibitor (Human) (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 measured how much of the activity of the enzyme elastase was inhibited by AAT.
The optimum deposition site (bronchial or peripheral) in CF patients for AAT was investigated by measuring several parameters in induced sputum. The study started with a 2 week run-in period in which the planned 60 patients inhale isotonic saline once daily. This period was followed by a 4 week treatment period where 30 patients inhaled AAT for peripheral deposition and 30 patients inhaled AAT for bronchial deposition. Six patients in each group were asked to collect spontaneous sputum at home.
Twenty-five milligrams of AAT was inhaled to be deposited at one of the two target sites using the AKITA device. The inhalation was scheduled to take place in the evening between 18.00 and 23.00 h.
Patients inhaled saline once daily for 2 weeks (run-in period) followed by 4 weeks of once daily inhalation of AAT. Induced sputum was collected at visits to the clinic at the start of the run-in, at the start of AAT treatment, and at 2 and 4 weeks after the start of AAT treatment.
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