Clinical trial NCT00581945: Safety and Efficacy of Multiple Doses of Canakinumab (ACZ885) in Chronic Obstructive Pulmonary Disease (COPD) Patients
Official title: A Randomized, Double-blind, Placebo Controlled, Exploratory Study to Assess the Safety and Efficacy of Multiple Doses of ACZ885 in Chronic Obstructive Pulmonary Disease (COPD) Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-12-28
Enrollment: 147
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Was to evaluate the safety, tolerability and efficacy of multiple doses of canakinumab (ACZ885) vs. placebo when administered via intravenous infusion (IV), on pulmonary function in patients with COPD


Eligibility criteria: Inclusion Criteria:

* Male and/or female subjects from 40-80 years (inclusive) of age
* Subjects have a clinical diagnosis of COPD
* Smokers or Ex-smokers with a smoking history of at least 20 pack years
* Post-bronchodilator forced expiratory volume in 1 second (FEV1 ) at screening ≤ 50% of the predicted normal value
* Post-bronchodilator FEV1/FVC ratio \< 70%
* History of at least one treated exacerbation during the 24 months year prior to screening or C-Reactive Protein (CRP) ≥3.47 mg/L,
* Subjects should have no concomitant other lung disease or significant concomitant medical conditions that would affect the subjects' safety when participating in the study, or that would be expected to impact on the results of the study
* Female subjects must have been surgically sterilized at least 6 months prior to screening or must be using two forms of contraception, or postmenopausal women
* Able to provide written informed consent prior to study participation.
* Able to communicate well with the investigator and comply with the requirements of the study.

Exclusion Criteria:

* COPD exacerbation(s) requiring treatment within 4 weeks prior to first dosing
* History of lung reduction surgery
* Any undiagnosed nodule on chest x-ray
* Presence of certain medical conditions as specified by the protocol
* Subjects requiring oral or parenteral corticosteroids equivalent to \> 10 mg/day or \> 20 mg every other day of prednisone or prednisolone
* Documented homozygous alpha-1 antitrypsin deficiency.
* Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation.
* Donation or loss of 400 mL or more of blood within 8 weeks prior to dosing.
* A past medical history of clinically significant electrocardiogram (ECG) abnormalities or a family history of a prolonged QT-interval syndrome.
* A known hypersensitivity to drugs similar to the study drug.
* History of immunocompromise, including a positive HIV test result.
* A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
* History of drug or alcohol abuse within the 12 months prior to screening or evidence of such abuse as indicated by the laboratory assays conducted during screening.

Primary outcomes:
measure: Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: Baseline, Week 25 and Week 45
measure: Change From Baseline in Forced Expiratory Volume in 1 Second Percent Predicted
timeFrame: Baseline, Week 25 and Week 45
measure: Change From Baseline in Forced Vital Capacity (FVC)
timeFrame: Baseline, Week 25 and Week 45
measure: Change From Baseline in Slow Vital Capacity (SVC)
timeFrame: Baseline, Week 25 and Week 45
measure: Change From Baseline in Forced Expiratory Flow 25% to 75%
timeFrame: Baseline, Week 25 and Week 45
Secondary outcomes:
measure: Number of Participants Who Experienced Serious Adverse Events or Discontinued Due to Adverse Events
timeFrame: Adverse events were collected during the 45 week treatment period and the 12 week follow-up period.
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Novartis Investigator Site
state: California
city: Los Angeles
country: United States
facility: Novartis Investigator Site
state: California
city: Panama City
country: United States
facility: Novartis Investigator Site
state: Florida
city: Marietta
country: United States
facility: Novartis Investigator Site
state: Georgia
city: Baltimore
country: United States
facility: Novartis Investigator Site
state: Maryland
city: Livonia
country: United States
facility: Novartis Investigator Site
state: Michigan
city: Minneapolis
country: United States
facility: Novartis Investigator Site
state: Minnesota
city: Omaha
country: United States
facility: Novartis Investigator Site
state: Nebraska
city: Buffalo
country: United States
facility: Novartis Investigator Site
state: New York
city: Spartanburg
country: United States
facility: Novartis Investigator Site
state: South Carolina
city: Richmond
country: United States
facility: Novartis Investigator Site
state: Virginia
Study officials:
affiliation: Novartis investigator site
name: NOVARTIS
role: PRINCIPAL_INVESTIGATOR
References: