Safety and Tolerability Study of Liquid Alpha1 Proteinase Inhibitor (API) in Subjects With Cystic Fibrosis

April 3, 2012 updated by: CSL Behring

A Double Blind, Randomized, Placebo Controlled, Single Dose, Phase I Study of the Safety and Tolerability of Alpha1 Proteinase Inhibitor (Human) Inhalation Solution (CR002) in Subjects With Cystic Fibrosis

Study to assess safety and tolerability of a single dose of study-drug administered to Cystic Fibrosis (CF) patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Sofia, Bulgaria
        • Site 11
      • Varna, Bulgaria
        • Site 12
  • Hungary
      • Debrecen, Hungary
        • Site 30
  • Poland
      • Bialystok, Poland
        • Site 24
      • Gdansk, Poland
        • Site 22
      • Poznan, Poland
        • Site 21
      • Rabka Zdroj, Poland
        • Site 20
      • Warszawa, Poland
        • Site 23
  • United Kingdom
      • Papworth Hospital, United Kingdom
        • Site 42
      • Penarth, United Kingdom
        • Site 40
      • Southampton, United Kingdom
        • Site 41

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Have a confirmed diagnosis of CF: one or more clinical findings consistent with CF and at least one of the following:

    1. Sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis test OR
    2. A genotype with two identifiable mutations consistent with CF (∆F508 homozygous or two alleles known to cause a class I, II, or III mutation)
  • Have an FEV1 ≥30% of predicted normal as defined by age, gender, and height

Exclusion Criteria:

  • Oxygen saturation <90%
  • Changed in treatment regimen within 2 weeks prior to screening
  • Antibiotics regimen change < 4 weeks before screening
  • Persistent colonization with Burkholderia cepacia
  • Serum IgA < 50% of lower level of normal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Biological: Placebo
A single nominal dose of Placebo will be inhaled as an aerosol mist produced by an I-neb Adaptive Aerosol Delivery (AAD) System.
EXPERIMENTAL: Liquid API
Biological: CR002 Liquid API
A single nominal dose of CR002 (three different dose groups) will be inhaled as an aerosol mist produced by an I-neb Adaptive Aerosol Delivery (AAD) System.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency of Adverse events
Time Frame: 44 Days (Day -21 to Day 22)
44 Days (Day -21 to Day 22)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CSL Behring

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (ACTUAL)

August 1, 2011

Study Completion (ACTUAL)

August 1, 2011

Study Registration Dates

First Submitted

May 3, 2011

First Submitted That Met QC Criteria

May 3, 2011

First Posted (ESTIMATE)

May 4, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

April 5, 2012

Last Update Submitted That Met QC Criteria

April 3, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR002_1004
  • 2010-022671-60 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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