Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00581945 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy of Multiple Doses of Canakinumab (ACZ885) in Chronic Obstructive Pulmonary Disease (COPD) Patients
A Phase 1 study, sponsored by Novartis.
- Completed
- Registry status
- Phase 1
- Development phase
- 147
- Enrollment target
NCT00581945: Completed Phase 1 study, sponsored by Novartis.
NCT00581945 is a Phase 1 study that has completed, run by Novartis. The registered enrollment target is 147 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (145% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00581945, a Phase 1 study, has completed, sponsored by Novartis.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 147 participants
- Enrollment target
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
Primary Outcome
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.
Interventions
- DRUG Placebo
- DRUG Canakinumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 147 participants |
| Start Date | 2007-01 |
| Est. Completion | 2010-05 |
| Phase | Phase 1 |
What the finished NCT00581945 record still lists
NCT00581945 is an interventional study that assigns participants to a tested intervention. The registered 147 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (145% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00581945 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00581945 about?
NCT00581945 is a clinical study titled "Safety and Efficacy of Multiple Doses of Canakinumab (ACZ885) in Chronic Obstructive Pulmonary Disease (COPD) Patients". 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
What is the current status of trial NCT00581945?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 147 participants. The study started on 2007-01. Estimated completion is 2010-05.
What interventions are being tested in trial NCT00581945?
The interventions under investigation include: Placebo (DRUG), Canakinumab (DRUG).
Who is sponsoring clinical trial NCT00581945?
This trial is sponsored by Novartis, which has 265 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00581945's enrollment target sits among peer trials
147 387th of 2000 higher than 1,610 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04396613 · 147 participants · NA
Wound Closure Techniques in Primary Spine Surgery
- NCT04851119 · 147 participants · Phase 1
Tegavivint for the Treatment of Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors
- NCT05523947 · 147 participants · Phase 1
Clinical Trial of YH32367 in Patients With HER2 Positive Locally Advanced or Metastatic Solid Tumor
- NCT06121843 · 147 participants · Phase 1
A Study to Evaluate the Safety, Effectiveness and Tolerable Dose of Arlocabtagene Autoleucel (BMS-986393) in Novel Combinations in Participants With Relapsed and/or Refractory Multiple Myeloma
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia