CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 72 enrolled
Drug / intervention
Alpha1-Proteinase Inhibitor (Human)drug
Likely dose
Alpha1-Proteinase Inhibitor (Human) 25 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00486837
NCT00486837Phase 2Completed
CompareCT.gov

Multicenter, Randomized, Parallel Group Study to Investigate the Optimal Deposition Site for Inhaled Prolastin® in Patients With Cystic Fibrosis (CF)

Grifols Therapeutics LLC·interventional·Posted Jun 15, 2007·Updated Aug 21, 2014

In Brief

A Phase 2 clinical trial evaluating Alpha1-Proteinase Inhibitor (Human) for Cystic Fibrosis. Completed, enrolled 72 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 15, 2007
Enrollment StartDec 1, 2003
Primary CompletionJun 1, 2004
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 19.0 years ago

Interventions

Alpha1-Proteinase Inhibitor (Human)drug

25 mg of Alpha1-Proteinase Inhibitor (Human) in the lungs, one inhalation per day over 4 weeks.