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Safety and Tolerability Trial of Inhaled Alpha1-Proteinase Inhibitor (Human), Hydrophobic Chromatography Process (Alpha-1 HC) in Subjects With Cystic Fibrosis

Information source: Grifols Therapeutics Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cystic Fibrosis

Intervention: Alpha-1 HC (Biological); Placebo (Biological)

Phase: Phase 2

Status: Completed

Sponsored by: Grifols Therapeutics Inc.

Summary

This is a randomized, double-blind, placebo-controlled, dose escalation study to assess the safety and tolerability of 100 mg and 200 mg of inhaled Alpha-1 HC administered once a day for three weeks in subjects aged 18 years and older with cystic fibrosis (CF). The treatment duration in this study is intended to provide multi-dose safety information prior to proceeding to longer durations of exposure.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Forced Expiratory Volume in 1 second (FEV1)

Adverse Events

Forced Vital Capacity (FVC)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Documentation of CF diagnosis

- Have a pre-bronchodilator FEV1 ≥ 40% of predicted at Visit 1 and have a Visit 2

pre-investigational product FEV1 that is ≥ 40% of predicted and within ± 15% of the Visit 1 result.

- Deemed by the Investigator to be a suitable candidate for serial collection of

expectorated sputum. Exclusion Criteria:

- Had a pulmonary exacerbation during the 4 weeks before screening (Visit 1) which

required the initiation of new antibiotic treatment

- Have a pulmonary exacerbation during the screening period (between Visit 1 and Visit

2) which requires the initiation of new antibiotic treatment

- FEV1 < 0. 59 liters at the screening visit

- Respiratory insufficiency with continuous supplemental oxygen therapy, or carbon

dioxide retention

- Elevated aspartate transaminase (AST) or alanine aminotransferase (ALT) that is >/= 3

times the upper limit of normal for age and gender

- Smoking during the past 6 months

- Lung surgery during the past 2 years

- Positive culture for Burkholderia cepacia or mycobacterium during the past two years.

- Active allergic bronchopulmonary aspergillosis

- Pre-treatment sputum collection at Visit 1 or Visit 2 (Randomization) characterized

by problems such as inadequate sputum volume or quality.

- Known selective Immunoglobulin A (IgA) deficiency with known antibody against IgA

(anti-IgA antibody).

- History of anaphylaxis or severe systemic response to any plasma-derived

alpha1-proteinase inhibitor preparation or other blood product(s), or to polysorbates.

- Use of chronic, high dose ibuprofen therapy within 3 weeks of screening and at

anytime during the study.

- Chronic maintenance therapy with systemic antibiotics within 3 weeks of screening and

through last dose of investigational product.

- Use of leukotriene synthesis inhibitor (zileuton) or leukotriene receptor antagonists

(montelukast, zafirlukast) within 3 weeks of screening and at anytime during the study.

- Use of roflumilast within 3 weeks of screening and at anytime during the study.

- Initiation of a new chronic medication or dosage change of a chronic medication for

treatment of cystic fibrosis (example: Kalydeco™ [ivacaftor]) within 3 weeks of screening (Visit 1).

Locations and Contacts

The University of Alabama at Birmingham, Birmingham, Alabama 35233, United States

National Jewish Hospital, Denver, Colorado 80206, United States

Children's Hospital Boston, Boston, Massachusetts 02115, United States

UNC at Chapel Hill, Chapel Hill, North Carolina 27599, United States

Rainbow Babies and Children's Hospital, Cleveland, Ohio 44106, United States

Medical University of South Carolina, Charleston, South Carolina 29425, United States

Additional Information

Starting date: August 2012
Last updated: November 26, 2013

Page last updated: August 23, 2015

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