Safety and Tolerability Trial of Inhaled Alpha1-Proteinase Inhibitor (Human), Hydrophobic Chromatography Process (Alpha-1 HC) in Subjects With Cystic Fibrosis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01684410|
Recruitment Status : Completed
First Posted : September 13, 2012
Results First Posted : February 8, 2016
Last Update Posted : February 8, 2016
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis||Biological: Alpha-1 HC 100 mg Biological: Placebo Biological: Alpha-1 HC 200 mg||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Three Week Dose Escalation, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Safety and Tolerability of 100 mg or 200 mg of Inhaled Alpha-1 HC, Once a Day in Subjects With Cystic Fibrosis.|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||October 2013|
Experimental: Alpha-1 HC 100 mg
100 mg of aerosolized Alpha-1 HC inhaled daily via nebulizer for 3 weeks.
Biological: Alpha-1 HC 100 mg
Alpha-1 HC is a sterile, liquid preparation of purified alpha1-proteinase inhibitor prepared from pooled human plasma. Alpha-1 HC 100 mg inhaled once daily for 21 days for a total of 21 inhaled treatments.
Experimental: Alpha-1 HC 200 mg
200 mg of aerosolized Alpha-1 HC inhaled daily via nebulizer for 3 weeks.
Biological: Alpha-1 HC 200 mg
Alpha-1 HC is a sterile, liquid preparation of purified alpha1-proteinase inhibitor prepared from pooled human plasma. Alpha-1 HC 200 mg inhaled once daily for 21 days for a total of 21 inhaled treatments.
Placebo Comparator: Placebo
Placebo inhaled daily via nebulizer for 3 weeks. Placebo (phosphate buffer saline with polysorbate).
Phosphate Buffer Saline with Polysorbate (placebo) composed of the same elements listed for Alpha-1 HC, minus the 50 mg/mL of Alpha-1 HC. Placebo inhaled once daily for 21 days for a total of 21 inhaled treatments.
- Adverse Events [ Time Frame: 3 weeks ]adverse event frequency
- Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 3 [ Time Frame: 3 weeks ]FEV1 conducted before and after inhalation of the investigational product at study visits.
- Percent Change From Baseline in Forced Vital Capacity (FVC) at Week 3 [ Time Frame: 3 weeks ]FVC conducted before and after inhalation of the investigational product
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01684410
|United States, Alabama|
|The University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35233|
|United States, Colorado|
|National Jewish Hospital|
|Denver, Colorado, United States, 80206|
|United States, Massachusetts|
|Children's Hospital Boston|
|Boston, Massachusetts, United States, 02115|
|United States, North Carolina|
|UNC at Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599|
|United States, Ohio|
|Rainbow Babies and Children's Hospital|
|Cleveland, Ohio, United States, 44106|
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|