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NCT00669617 · ClinicalTrials.gov registry record · Phase 3
Study to Determine the Onset of Action of Indacaterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
A Phase 3 study, sponsored by Novartis.
- Completed
- Registry status
- Phase 3
- Development phase
- 89
- Enrollment target
NCT00669617: Completed Phase 3 study, sponsored by Novartis.
NCT00669617 is a Phase 3 study that has completed, run by Novartis. The registered enrollment target is 89 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00669617, a Phase 3 study, has completed, sponsored by Novartis.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 89 participants
- Enrollment target
Study Summary
This study will evaluate the onset of action of indacaterol (150 and 300 µg) as compared to placebo, salbutamol 200 µg and salmeterol/fluticasone 50/500 µg
Primary Outcome
FEV1 was measured at 5 minutes after dosing with spirometry conducted according to internationally accepted standards. The time of dosing was defined as the time corresponding to the use of the first inhaler device. The primary variable was analyzed using a mixed model containing the period baseline FEV1 as covariate. The period baseline FEV1 was the average of the FEV1 value measured in the clinic at 50 and 15 min prior to the study drug administration in that period.
Interventions
- DRUG Indacaterol
- DRUG Placebo to Indacaterol
- DRUG Salmeterol/fluticasone (50/500 μg)
- DRUG Salbutamol (200 µg)
- DRUG Placebo to Salmeterol/fluticasone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 89 participants |
| Start Date | 2008-04 |
| Est. Completion | 2008-08 |
| Phase | Phase 3 |
What the finished NCT00669617 record still lists
NCT00669617 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 89 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 5 interventions - of which Indacaterol is the first listed.
NCT00669617 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00669617 about?
NCT00669617 is a clinical study titled "Study to Determine the Onset of Action of Indacaterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)". This study will evaluate the onset of action of indacaterol (150 and 300 µg) as compared to placebo, salbutamol 200 µg and salmeterol/fluticasone 50/500 µg
What is the current status of trial NCT00669617?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 89 participants. The study started on 2008-04. Estimated completion is 2008-08.
What interventions are being tested in trial NCT00669617?
The interventions under investigation include: Indacaterol (DRUG), Placebo to Indacaterol (DRUG), Salmeterol/fluticasone (50/500 μg) (DRUG), Salbutamol (200 µg) (DRUG), Placebo to Salmeterol/fluticasone (DRUG).
Who is sponsoring clinical trial NCT00669617?
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 NCT00669617's enrollment target sits among peer trials
89 1738th of 2000 higher than 262 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
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