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NCT01089127 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Different Doses of Indacaterol in Chronic Obstructive Pulmonary Disease (COPD)
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 552
- Enrollment target
NCT01089127: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT01089127 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 552 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01089127, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 552 participants
- Enrollment target
Study Summary
This study compared the 14-day bronchodilator efficacy of indacaterol with that of placebo and salmeterol.
Primary Outcome
FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. 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 screening as covariates.
Interventions
- DRUG Placebo to indacaterol
- DRUG Salmeterol 50 μg
- DRUG Placebo to salmeterol
- DRUG Indacaterol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 552 participants |
| Start Date | 2010-03 |
| Est. Completion | 2010-07 |
| Phase | Phase 3 |
What the finished NCT01089127 record still lists
NCT01089127 is an interventional study that assigns participants to a tested intervention. The registered 552 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (28% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo to indacaterol is the first listed.
NCT01089127 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01089127 about?
NCT01089127 is a clinical study titled "Efficacy and Safety of Different Doses of Indacaterol in Chronic Obstructive Pulmonary Disease (COPD)". This study compared the 14-day bronchodilator efficacy of indacaterol with that of placebo and salmeterol.
What is the current status of trial NCT01089127?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 552 participants. The study started on 2010-03. Estimated completion is 2010-07.
What interventions are being tested in trial NCT01089127?
The interventions under investigation include: Placebo to indacaterol (DRUG), Salmeterol 50 μg (DRUG), Placebo to salmeterol (DRUG), Indacaterol (DRUG).
Who is sponsoring clinical trial NCT01089127?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01089127's enrollment target sits among peer trials
552 678th of 2000 higher than 1,321 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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