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CompletedNCT00581945Updated Jun 30, 2011Results posted

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

A Phase 1/2 interventional study of Canakinumab and Placebo in Chronic Obstructive Pulmonary Disease, sponsored by Novartis. Completed at 11 sites in United States. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2011-06-30.

Sponsored by Novartis · Phase 1/2, Interventional, and Basic science

Phase
Phase 1/2
Study type
Interventional
Enrollment
147
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
01

Study 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

02

Conditions studied

  • Chronic Obstructive Pulmonary Disease
03

In context

Pulmonary Disease, Chronic Obstructive

4,252 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 707 are open to participants now.

This study's enrollment of 147 is above the median of 70 across 3,008 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

Novartis is the lead sponsor of 714 studies on the registry; none are open to participants now.

Browse Novartis studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
147 participants (actual)

Study 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.

    Drug: Canakinumab

  • 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.

    Drug: Placebo

Interventions

  • DrugCanakinumab

    The dose of canakinumab (ACZ885) administered was individualized, based on the subject's weight pre-dose, and was administered via intravenous infusion.

  • DrugPlacebo

    Matching placebo to ACZ885 administered via intravenous infusion.

06

What researchers measure

Primary outcomes

  1. Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)

    Forced expiratory volume in 1 second (FEV1) is the amount of air that can be exhaled in one second. FEV1 was measured by spirometry performed at approximately the same time of day on each visit to avoid diurnal variation. All spirometry calibrations and evaluations followed the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability. A positive change from baseline in FEV1 indicates improvement in lung function.

    Time frame: Baseline, Week 25 and Week 45

  2. Change From Baseline in Forced Expiratory Volume in 1 Second Percent Predicted

    The FEV1 percent predicted expresses FEV1 as a percentage of the "predicted values" for participants of similar characteristics (height, age, sex, and sometimes race and weight). A positive change from baseline in FEV1 % predicted indicates improvement in lung function.

    Time frame: Baseline, Week 25 and Week 45

  3. Change From Baseline in Forced Vital Capacity (FVC)

    Forced Vital Capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed by spirometry. A positive change from baseline in FVC indicates improvement in lung function.

    Time frame: Baseline, Week 25 and Week 45

  4. Change From Baseline in Slow Vital Capacity (SVC)

    Vital Capacity is the amount of air that can be forcibly exhaled from the lungs after a full inhalation. Slow Vital Capacity (SVC) test is performed by having the patient slowly and completely blow out all of the air from their lungs. A positive change from baseline in SVC indicates improvement in lung function.

    Time frame: Baseline, Week 25 and Week 45

  5. Change From Baseline in Forced Expiratory Flow 25% to 75%

    The forced expiratory flow (FEF) 25%-75% measurement describes the amount of air expelled from the lungs during the middle half (25% - 75%) of the forced vital capacity test and is measured using spirometry. A positive change from baseline in FEF indicates improvement in lung function.

    Time frame: Baseline, Week 25 and Week 45

Secondary outcomes

  1. Number of Participants Who Experienced Serious Adverse Events or Discontinued Due to Adverse Events

    Safety was assessed by the number of participants with serious adverse events and/or adverse events leading to study discontinuation. A summary of adverse events is presented with this outcome, additional details are provided in the Adverse Events section.

    Time frame: Adverse events were collected during the 45 week treatment period and the 12 week follow-up period.

07

Results

Posted Jun 27, 2011

Participant flow

Participant flow — Overall Study
MilestoneCanakinumabPlacebo
Started7473
Completed6563
Not completed910
Withdrew: Adverse event44
Withdrew: Unsatisfactory therapeutic effect20
Withdrew: Withdrawal by subject26
Withdrew: Death10

Outcome measures

PrimaryChange From Baseline in Forced Expiratory Volume in 1 Second (FEV1)

Forced expiratory volume in 1 second (FEV1) is the amount of air that can be exhaled in one second. FEV1 was measured by spirometry performed at approximately the same time of day on each visit to avoid diurnal variation. All spirometry calibrations and evaluations followed the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability. A positive change from baseline in FEV1 indicates improvement in lung function.

Time frame:
Baseline, Week 25 and Week 45
Reported as:
Mean · Liters
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
LitersCanakinumabPlacebo
Change from Baseline at Week 25-0.027 ± 0.1725-0.006 ± 0.2545
Change from Baseline at Week 45-0.044 ± 0.1542-0.033 ± 0.2512
SecondaryNumber of Participants Who Experienced Serious Adverse Events or Discontinued Due to Adverse Events

Safety was assessed by the number of participants with serious adverse events and/or adverse events leading to study discontinuation. A summary of adverse events is presented with this outcome, additional details are provided in the Adverse Events section.

Time frame:
Adverse events were collected during the 45 week treatment period and the 12 week follow-up period.
Reported as:
Number · Participants
Number of Participants Who Experienced Serious Adverse Events or Discontinued Due to Adverse Events
ParticipantsCanakinumabPlacebo
Serious Adverse Events2314
Death10
Discontinued due to Adverse Events44
Discontinued due to Serious Adverse Events34
Discontinued due to non-serious AEs10
PrimaryChange From Baseline in Forced Expiratory Volume in 1 Second Percent Predicted

The FEV1 percent predicted expresses FEV1 as a percentage of the "predicted values" for participants of similar characteristics (height, age, sex, and sometimes race and weight). A positive change from baseline in FEV1 % predicted indicates improvement in lung function.

Time frame:
Baseline, Week 25 and Week 45
Reported as:
Mean · Percent of predicted
Change From Baseline in Forced Expiratory Volume in 1 Second Percent Predicted
Percent of predictedCanakinumabPlacebo
Change from Baseline at Week 25-0.2 ± 6.420.3 ± 8.86
Change from Baseline at Week 45-1.0 ± 5.35-0.7 ± 8.49
PrimaryChange From Baseline in Forced Vital Capacity (FVC)

Forced Vital Capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed by spirometry. A positive change from baseline in FVC indicates improvement in lung function.

Time frame:
Baseline, Week 25 and Week 45
Reported as:
Mean · liters
Change From Baseline in Forced Vital Capacity (FVC)
litersCanakinumabPlacebo
Change from Baseline at Week 25-0.010 ± 0.3720-0.061 ± 0.4856
Change from Baseline at Week 45-0.039 ± 0.3122-0.065 ± 0.5170
PrimaryChange From Baseline in Slow Vital Capacity (SVC)

Vital Capacity is the amount of air that can be forcibly exhaled from the lungs after a full inhalation. Slow Vital Capacity (SVC) test is performed by having the patient slowly and completely blow out all of the air from their lungs. A positive change from baseline in SVC indicates improvement in lung function.

Time frame:
Baseline, Week 25 and Week 45
Reported as:
Mean · liters
Change From Baseline in Slow Vital Capacity (SVC)
litersCanakinumabPlacebo
Change from Baseline at Week 25-0.029 ± 0.3746-0.019 ± 0.5082
Change from Baseline at Week 45-0.062 ± 0.3727-0.017 ± 0.5379
PrimaryChange From Baseline in Forced Expiratory Flow 25% to 75%

The forced expiratory flow (FEF) 25%-75% measurement describes the amount of air expelled from the lungs during the middle half (25% - 75%) of the forced vital capacity test and is measured using spirometry. A positive change from baseline in FEF indicates improvement in lung function.

Time frame:
Baseline, Week 25 and Week 45
Reported as:
Mean · L/sec
Change From Baseline in Forced Expiratory Flow 25% to 75%
L/secCanakinumabPlacebo
Change from Baseline at Week 25-0.022 ± 0.1060-0.002 ± 0.1111
Change from Baseline at Week 45-0.024 ± 0.0898-0.012 ± 0.1244

Adverse events

Collected over Adverse events were collected over the 45-week treatment period.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Canakinumab—23/74 (31.1%)59/74 (79.7%)
Placebo—14/73 (19.2%)51/73 (69.9%)
Most frequent serious events
Showing 10 of 33
Most frequent serious events
EventCanakinumabPlacebo
Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders9/747/73
PneumoniaInfections and infestations4/743/73
BronchitisInfections and infestations2/740/73
Bronchopulmonary aspergillosisInfections and infestations2/740/73
Staphylococcal infectionInfections and infestations2/740/73
Benign prostatic hyperplasiaReproductive system and breast disorders2/740/73
Acute myocardial infarctionCardiac disorders0/741/73
Angina unstableCardiac disorders0/741/73
Coronary artery diseaseCardiac disorders1/741/73
PalpitationsCardiac disorders0/741/73
Most frequent other events
Showing 10 of 16
Most frequent other events
EventCanakinumabPlacebo
Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders38/7436/73
Upper respiratory tract infectionInfections and infestations9/744/73
CoughRespiratory, thoracic and mediastinal disorders8/746/73
PyrexiaGeneral disorders7/747/73
NauseaGastrointestinal disorders5/746/73
SinusitisInfections and infestations6/745/73
DiarrhoeaGastrointestinal disorders5/745/73
VomitingGastrointestinal disorders5/741/73
Back painMusculoskeletal and connective tissue disorders5/744/73
DyspepsiaGastrointestinal disorders0/744/73

Baseline characteristics

Age Continuous
Age Continuous(years)CanakinumabPlaceboTotal
Mean63.9 ± 7.7063.6 ± 7.9263.7 ± 7.78
Sex: Female, Male
Sex: Female, Male(Participants)CanakinumabPlaceboTotal
Female283159
Male464288
08

Study locations

11 sites
  • Novartis Investigator Site
    Anaheim, California 92801, United States
  • Novartis Investigator Site
    Los Angeles, California 90095, United States
  • Novartis Investigator Site
    Panama City, Florida 32405, United States
  • Novartis Investigator Site
    Marietta, Georgia 300060, United States
  • Novartis Investigator Site
    Baltimore, Maryland 21224, United States
  • Novartis Investigator Site
    Livonia, Michigan 48152, United States
  • Novartis Investigator Site
    Minneapolis, Minnesota 55402, United States
  • Novartis Investigator Site
    Omaha, Nebraska 68198-5885, United States
  • Novartis Investigator Site
    Buffalo, New York 14215, United States
  • Novartis Investigator Site
    Spartanburg, South Carolina 29303, United States
  • Novartis Investigator Site
    Richmond, Virginia 23225, United States
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2007, a primary completion of May 2010 and a completion of May 2010. It does not say whether these dates are actual or estimated.

Results were first posted in Jun 2011, 1 year 1 month after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 21, 2007
First posted
Dec 28, 2007
Start
Jan 2007
Primary completionActual
May 2010
CompletionActual
May 2010
Results first posted
Jun 27, 2011
Last update
Jun 30, 2011
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 30, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00581945
Lead sponsor
Novartis
First posted
Dec 28, 2007
Start date
Jan 2007
Primary completion
May 2010
Completion
May 2010
Results posted
Jun 27, 2011
Last update
Jun 30, 2011

Study contacts

NOVARTIS
principal investigator · Novartis investigator site

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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