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Clinical Trial Finder
Anti-Inflammatory Completed with Results
Phase 2 study of inhaled Alpha-1 HC in people with CF (Grifols T6005-201)
This Phase 2 study assessed the safety and tolerability of two different doses of once daily inhaled Alpha-1 anti-trypsin in people with CF.
Participants were randomized to receive either Alpha-1 anti-trypsin at a dose of 100 mg or 200 mg or placebo once a day for three weeks. The short treatment duration in this study was meant to provide multi-dose safety information before proceeding to longer durations of exposure.
Eligibility
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Age:
18 Years and Older -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
40 to 90%
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
Study Results
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What We Learned:
Adverse events were similar across the two Alpha-1 anti-trypsin dosage groups and the placebo group in this study. No participants discontinued participation in the study due to a treatment related adverse event. The way the drug was administered effectively increased the concentration of alpha-1 antitrypsin in sputum.
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Primary Findings:
Effectiveness:
This study was conducted between August 2012 and October 2013. The primary endpoint was the frequency of adverse events. A total of 30 participants were randomized into one of three treatment groups: 100mg or 200 mg of Alpha-1 anti-trypsin or placebo inhaled once daily (N=10 in each treatment group). All participants completed the 3-week study.
Drug delivery was confirmed by a dose-dependent increase in alpha-1-anti-trypsin level in CF sputum.
Safety:
The adverse event profile was generally similar across all treatment groups. Investigators, who were blinded to study treatment, assessed many of the adverse events as possibly related to study treatment. The frequency of the adverse events was: 100mg dose= 50% participants, 200mg dose= 10% participants and placebo=20% participants.
One serious adverse event (SAE) occurred in one participant within each group and no SAE was deemed related to the study drug. No participants discontinued participation in the study due to study related adverse events.
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Citation:
J Cyst Fibros ;DOI 10.1016/j.jcf.2015.07.009
For current information about the overall development status of this drug, please check the Drug Development Pipeline.
Study Design
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Study Type: ?more info
Interventional -
Randomized Study: ?more info
Yes -
Placebo Controlled: ?more info
Yes -
Length of Participation:
9 weeks -
Number of Study Visits:
5
Additional Information
-
Phase: ?more info
Phase Two -
Study Sponsor: ?more info
Grifols S.A. -
Study Drugs:
Eligibility
-
Age:
18 Years and Older -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
40 to 90%
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.

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