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

Cystic Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01347190
• Other study ID #: CR002_1004
• Secondary ID: 2010-022671-60
• Status: Completed
• Phase: Phase 1
• First received: May 3, 2011
• Last updated: April 3, 2012
• Start date: April 2011
• Est. completion date: August 2011

Study information

• Verified date: April 2012
• Source: CSL Behring
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bulgaria: Ministry of HealthHungary: National Institute of PharmacyPoland: Ministry of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Alpha 1-Antitrypsin Deficiency
• Cystic Fibrosis
• Fibrosis

Intervention

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.
• Placebo
A single nominal dose of Placebo will be inhaled as an aerosol mist produced by an I-neb Adaptive Aerosol Delivery (AAD) System.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
CSL Behring

Countries where clinical trial is conducted

Bulgaria,  Hungary,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of Adverse events		44 Days (Day -21 to Day 22)	Yes