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NCT00877383 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Indacaterol Plus Tiotropium Versus Tiotropium Alone in Patients With Chronic Obstructive Pulmonary Disease
A Phase 3 study of Chronic Obstructive Pulmonary Disease (COPD), sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,142
- Enrollment target
- 20
- Study locations
NCT00877383: Completed Phase 3 study of Chronic Obstructive Pulmonary Disease (COPD), sponsored by Novartis Pharmaceuticals.
NCT00877383 is a Phase 3 study of Chronic Obstructive Pulmonary Disease (COPD) that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 1,142 participants, above the 619-participant average among 36 other Chronic Obstructive Pulmonary Disease (COPD) trials with a reported enrollment target (84% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00877383, a Phase 3 study of Chronic Obstructive Pulmonary Disease (COPD), has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,142 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study assessed the efficacy and safety of indacaterol (150 µg once daily \[od\]) when combined with tiotropium (18 µg od) versus tiotropium (18 µg od) treatment alone in patients with chronic obstructive pulmonary disease (COPD).
Primary Outcome
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, 4, 6, and 8 hours post-dose at the end of the study (Week 12, Day 84). The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during
Conditions Studied
Interventions
- DRUG Placebo to indacaterol
- DRUG Indacaterol 150 μg
- DRUG Tiotropium 18 μg
Study Locations (20)
California
- Novartis Investigator Site - Buena Park
- Novartis Investigator Site - Fullerton
- Novartis Investigator Site - Mission Viejo
- Novartis Investigator Site - San Ramon
- Novartis Investigator Site - Santa Barbara
- Novartis Investigator Site - Sepulveda
- Novartis Investigator Site - Spring Valley
- Novartis Investigator Site - Torrance
- Novartis Investigator Site - Torrance
- Novartis Investigator Site - Vista
Alabama
- Novartis Investigator Site - Anniston
- Novartis Investigator Site - Birmingham
- Novartis Investigator Site - Jasper
- Novartis Investigator Site - Mobile
Arizona
- Novartis Investigator Site - Glendale
- Novartis Investigator Site - Phoenix
- Novartis Investigator Site - Phoenix
- Novartis Investigator Site - Scottsdale
Arkansas
- Novartis Investigator Site - Little Rock
Colorado
- Novartis Investigator Site - Boulder
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,142 participants |
| Start Date | 2009-04 |
| Est. Completion | 2010-02 |
| Phase | Phase 3 |
What the finished NCT00877383 record still lists
NCT00877383 is an interventional study that assigns participants to a tested intervention. Its 1,142 participants enrollment target places it among the larger protocols in the corpus, above the 619-participant average among 36 other Chronic Obstructive Pulmonary Disease (COPD) trials with a reported enrollment target (84% higher).
The record links to 1 condition, with Chronic Obstructive Pulmonary Disease (COPD) appearing as the primary indexed condition, and to 3 interventions - of which Placebo to indacaterol is the first listed.
NCT00877383 names 20 study sites across 5 states, led by California, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT00877383 about?
NCT00877383 is a clinical study titled "Efficacy and Safety of Indacaterol Plus Tiotropium Versus Tiotropium Alone in Patients With Chronic Obstructive Pulmonary Disease". This study assessed the efficacy and safety of indacaterol (150 µg once daily \[od\]) when combined with tiotropium (18 µg od) versus tiotropium (18 µg od) treatment alone in patients with chronic obstructive pulmonary disease (COPD).
What is the current status of trial NCT00877383?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,142 participants. The study started on 2009-04. Estimated completion is 2010-02.
What conditions does trial NCT00877383 study?
This clinical trial studies the following conditions: Chronic Obstructive Pulmonary Disease (COPD).
What interventions are being tested in trial NCT00877383?
The interventions under investigation include: Placebo to indacaterol (DRUG), Indacaterol 150 μg (DRUG), Tiotropium 18 μg (DRUG).
Who is sponsoring clinical trial NCT00877383?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00877383 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Obstructive Pulmonary Disease (COPD)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00877383's enrollment target sits among peer trials
1,142 8th of 36 higher than 29 of 36 other Chronic Obstructive Pulmonary Disease (COPD) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Obstructive Pulmonary Disease (COPD) 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.
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