Safety and Efficacy of Multiple Doses of Canakinumab (ACZ885) in Chronic Obstructive Pulmonary Disease (COPD) Patients

Part of paid clinical trials in Anaheim, California.

Sponsor
Novartis
Study ID
NCT00581945
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Canakinumab — DRUG
    The dose of canakinumab (ACZ885) administered was individualized, based on the subject's weight pre-dose, and was administered via intravenous infusion.
  • Placebo — DRUG
    Matching placebo to ACZ885 administered via intravenous infusion.

Study Details

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

Key Dates

Start date
Jan 31, 2007
Status verified
Jun 2011
Primary completion
May 31, 2010
Completion
May 31, 2010

Study Design

Enrollment
147 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Canakinumab
    Participants received an initial dose of 1 mg/kg canakinumab (ACZ885) via intravenous infusion. Four weeks later, participants received a dose of 3 mg/kg canakinumab, and another dose of 3 mg/kg two weeks later. Thereafter, participants received doses of 6 mg/kg every four weeks until completion of the 45-week treatment period.
  • Placebo Comparator: Placebo
    Participants received a matching placebo intravenous infusion at weeks 1, 5, 7, and thereafter every four weeks until completion of the 45-week treatment period.

Primary Outcome Measure

Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Baseline, Week 25 and Week 45 ]

Locations (11)

FacilityCityStateZIPSite coordinators
Novartis Investigator SiteAnaheimCalifornia92801-
Novartis Investigator SiteLos AngelesCalifornia90095-
Novartis Investigator SitePanama CityFlorida32405-
Novartis Investigator SiteMariettaGeorgia300060-
Novartis Investigator SiteBaltimoreMaryland21224-
Novartis Investigator SiteLivoniaMichigan48152-
Novartis Investigator SiteMinneapolisMinnesota55402-
Novartis Investigator SiteOmahaNebraska68198-5885-
Novartis Investigator SiteBuffaloNew York14215-
Novartis Investigator SiteSpartanburgSouth Carolina29303-
Novartis Investigator SiteRichmondVirginia23225-

Find similar trials in Anaheim, CA

By condition
COPD
By specialty
PulmonologyLung disease
By research site
Novartis Investigator Site· Anaheim, CANovartis Investigator Site· Los Angeles, CANovartis Investigator Site· Panama City, FLNovartis Investigator Site· Marietta, GANovartis Investigator Site· Baltimore, MDNovartis Investigator Site· Livonia, MI

Related Studies