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Safety Study of an Aerosolized, Recombinant Alpha 1-Antitrypsin in Subjects With Alpha 1-Antitrypsin Deficiency
This study has been completed.
Sponsors and Collaborators: Baxter Healthcare Corporation
Arriva Pharmaceuticals, Inc.
Information provided by: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT00161707
  Purpose

The purpose of this randomized, double-blind, placebo-controlled study is to evaluate the short-term safety of inhaled recombinant alpha 1-antitrypsin (rAAT) in subjects with alpha 1-antitrypsin deficiency. The subjects are randomized to receive placebo or one of 4 doses of rAAT. The 4 doses are tested in a consecutive manner from lowest to highest.


Condition Intervention Phase
Alpha 1-Antitrypsin Deficiency
Drug: Aerosolized, Recombinant Alpha 1-Antitrypsin
Phase I
Phase II

Genetics Home Reference related topics: alpha-1 antitrypsin deficiency
MedlinePlus related topics: Alpha-1 Antitrypsin Deficiency
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety Study
Official Title: Phase I Safety Investigation of an Aerosolized, Recombinant Alpha 1-Antitrypsin in Subjects With Alpha 1-Antitrypsin Deficiency

Further study details as provided by Baxter Healthcare Corporation:

Study Start Date: January 2003
Estimated Study Completion Date: October 2003
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female 18 years of age or older
  • Endogenous plasma AAT levels < 11 µM (< 80 mg/dL)
  • Baseline forced expiratory volume at one second (FEV1) that is >= 50% of predicted, measured 30 minutes after a short-acting inhaled bronchodilator
  • Baseline arterial oxygen percent saturation (SaO2) within the normal limits for the individual study site
  • For subjects receiving an inhaled corticosteroid, β-2 agonist (eg, albuterol via metered dose inhaler [MDI]) or anticholinergic bronchodilator (eg, ipratropium bromide), treatment on a stable dose for at least 14 days prior to randomization
  • If female of childbearing potential, negative urine pregnancy test within 3 days prior to randomization and agreement to employ adequate birth control measures
  • No clinically significant abnormalities detected on a 12-lead electrocardiogram (ECG) performed no more than 7 days prior to randomization
  • Baseline laboratory results, obtained no more than 7 days prior to randomization, meeting the following criteria:
  • Serum aspartate transaminase (AST) and alanine transaminase (ALT) <= 2 times upper limit of normal range (ULN)
  • Serum total bilirubin <= 2 times ULN
  • < 2+ proteinuria on urine dipstick
  • Serum creatinine <= 1.5 times ULN
  • Absolute neutrophil count >= 1500 cells/mm3
  • Hemoglobin >= 10.0 g/dL
  • Platelet count >= 100,000/mm3
  • Signed informed consent

Exclusion Criteria:

  • Clinically significant pulmonary impairment, other than emphysema and/or chronic bronchitis
  • Clinically significant cardiac, hemostatic, or neurologic impairment, or other significant medical condition that, in the opinion of the investigator, would affect subject safety or compliance
  • Psychiatric or cognitive disturbance or illness, or recreational drug/alcohol use that, in the opinion of the investigator, would affect subject safety or compliance
  • Acute exacerbation of emphysema (as defined in Section 8.5.10) within 28 days prior to randomization
  • Pregnancy or lactation
  • Known history of allergy to yeast products
  • Medical history precluding the use of epinephrine or other rescue medication for treatment of anaphylaxis
  • Use of antihistamines within 7 days prior to randomization
  • Use of oral steroids, beta-blockers, or tricyclic antidepressants within 28 days prior to randomization
  • Use of another investigational drug or investigational device within 28 days prior to randomization
  • Any upper or lower respiratory infection within 28 days prior to randomization
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00161707

Locations
United States, Colorado
National Jewish Medical and Research Center
Denver, Colorado, United States, 80206
United States, Florida
Shands Hospital at the University of Florida
Gainesville, Florida, United States, 32610
United States, Ohio
Cleveland Clinic Foundation, Department of Pulmonary and Critical Care Medicine
Cleveland, Ohio, United States, 44195
United States, Texas
The University of Texas Health Science Center at Tyler
Tyler, Texas, United States, 75708-3154
Sponsors and Collaborators
Baxter Healthcare Corporation
Arriva Pharmaceuticals, Inc.
Investigators
Principal Investigator: Mark Brantly, MD Shands Hospital at the University of Florida
  More Information

Study ID Numbers: 410103
Study First Received: September 8, 2005
Last Updated: October 18, 2006
ClinicalTrials.gov Identifier: NCT00161707  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Protein C Inhibitor
Alpha 1-Antitrypsin
Protein C
Alpha 1-Antitrypsin Deficiency
Alpha 1-antitrypsin deficiency
Connective Tissue Diseases

Additional relevant MeSH terms:
Serine Proteinase Inhibitors
Molecular Mechanisms of Pharmacological Action
Trypsin Inhibitors
Enzyme Inhibitors
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009