A Study to Evaluate the Effectiveness of a Drug (MEDI-563) in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

COPD Clinical Trial

Official title:

A Phase 2a, Double-blind, Placebo-controlled Study to Evaluate the Efficacy of MEDI-563 in Subjects With Moderate-to-severe COPD and Sputum Eosinophilia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01227278
• Other study ID #: MI-CP196
• Secondary ID: 2010-020127-52
• Status: Completed
• Phase: Phase 2
• First received: October 21, 2010
• Last updated: April 3, 2014
• Start date: November 2010
• Est. completion date: July 2013

Study information

• Verified date: April 2014
• Source: MedImmune LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

To evaluate the effect of the drug in moderate to severe Chronic Obstructive Pulmonary Disease (COPD) in Adults

Description:

To evaluate the effect of multiple subcutaneous (SC) doses of MEDI 563 on the rate of moderate-to-severe AECOPD in adult subjects with moderate-to-severe COPD who exhibit eosinophilia (≥ 3.0% sputum eosinophilia in the previous 12 months or at screening) in sputum compared to placebo.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 421
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 85 Years

Eligibility

Inclusion Criteria:

• Subjects aged 40-85 years at the time of screening.

• Written informed consent obtained from the subject prior to performing any protocol related procedures.

• Documented history of 1 or more AECOPD.

• Current smoker or ex-smoker with a tobacco history of = 10 pack-years.

• Adequate contraception from screening through end of trial.

• Able to read and write.

Exclusion Criteria:

• Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results.

• Pregnant, breastfeeding, or lactating women.

• Known history of allergy or reaction to any component of the investigational product formulation.

• History of anaphylaxis to any other biologic therapy.

• Donation or transfusion of blood, plasma or platelets within the past 3 months prior to screening.

• Other significant pulmonary disease which in the opinion of the investigator or medical monitor, might compromise the interpretation of the study.

• Fever > 37.0°C (98.6°F) at screening.

• Receipt of any novel investigational medicinal product within 3 months before the first dose of investigational product in this study and through the end of the study.

• Seropositive for hepatitis A, hepatitis B surface antigen, hepatitis C, or human immunodeficiency virus (HIV-1 or HIV 2).

• History of alcohol or drug abuse within the past year that required treatment that the investigator felt or medical monitor felt would compromise the study data interpretation.

• Past or current malignancy within the past 5 years except adequately treated non-invasive basal cell and squamous cell carcinoma of the skin and cervical carcinoma in situ treated with apparent success more than 1 year prior to screening.

• Subjects participating in, or scheduled for, an intensive COPD rehabilitation program (subjects who are in the maintenance phase of a rehabilitation program are eligible to take part).

• Current diagnosis of asthma according to Global Initiative for Asthma guidelines.

• Previous treatment with MEDI-563.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• COPD
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• MEDI-563
SC injection every 28 days (3 doses) and every 56 days for the next (5 doses).

Other:
• Placebo
Placebo SC injection every 28 days (first 3 doses) and every 56 days for (next 5 doses).

Locations

Country	Name	City	State
Canada	Research Site	Calgary	Alberta
Canada	Research Site	Hamilton	Ontario
Canada	Research Site	Quebec
Canada	Research Site	Saskatoon	Saskatchewan
Denmark	Research Site	Århus C
Denmark	Research Site	Hellerup
Denmark	Research Site	København NV
Denmark	Research Site	Odense C
Germany	Research Site	Frankfurt
Germany	Research Site	Mainz
Poland	Research Site	Gdansk
Poland	Research Site	Kraków
Poland	Research Site	Lódz
Poland	Research Site	Warszawa
Spain	Research Site	Barcelona
Spain	Research Site	Lérida
Spain	Research Site	Málaga
Spain	Research Site	Oviedo
United Kingdom	Research Site	Cambridge
United Kingdom	Research Site	Edinburgh
United Kingdom	Research Site	Leicester
United Kingdom	Research Site	Manchester
United States	Research Site	Boerne	Texas
United States	Research Site	Brooklyn	New York
United States	Research Site	Greenville	South Carolina
United States	Research Site	Los Angeles	California
United States	Research Site	Marietta	Georgia
United States	Research Site	Normal	Illinois
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Richmond	Virginia
United States	Research Site	Tyler	Texas

Sponsors (2)

Lead Sponsor	Collaborator
MedImmune LLC	AstraZeneca

Countries where clinical trial is conducted

United States,  Canada,  Denmark,  Germany,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate multiple SC doses of MEDI 563 on the rate of moderate-to-severe acute exacerbations in COPD (AECOPD) in adult subjects.	Testing the differences in number of moderate-to-severe AECOPDs between the MEDI-563 treatment group and the placebo group.	Study Day 393	Yes
Secondary	Adverse Events and Severe Adverse Events will be categorically summarized by organ class and relationship to investigational product.		Study Day 561	Yes

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