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NCT00900731 · ClinicalTrials.gov registry record · Phase 3
A Study to Compare the Lung Effect of Indacaterol and Tiotropium in Chronic Obstructive Pulmonary Disease (COPD)
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,598
- Enrollment target
NCT00900731: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT00900731 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 1,598 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (107% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00900731, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,598 participants
- Enrollment target
Study Summary
This study compared the lung effects of indacaterol to those of tiotropium in patients with moderate to severe chronic obstructive pulmonary disease (COPD) over a 12 week period.
Primary Outcome
Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 hour 10 minute and 23 hour 45 minute post-dose FEV1 readings. Mixed model used baseline FEV1, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.
Interventions
- DRUG Placebo to indacaterol
- DRUG Indacaterol 150 μg
- DRUG Tiotropium 18 μg
- DRUG Placebo to tiotropium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,598 participants |
| Start Date | 2009-06 |
| Est. Completion | 2010-03 |
| Phase | Phase 3 |
What the finished NCT00900731 record still lists
NCT00900731 is an interventional study that assigns participants to a tested intervention. Its 1,598 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (107% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo to indacaterol is the first listed.
NCT00900731 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00900731 about?
NCT00900731 is a clinical study titled "A Study to Compare the Lung Effect of Indacaterol and Tiotropium in Chronic Obstructive Pulmonary Disease (COPD)". This study compared the lung effects of indacaterol to those of tiotropium in patients with moderate to severe chronic obstructive pulmonary disease (COPD) over a 12 week period.
What is the current status of trial NCT00900731?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,598 participants. The study started on 2009-06. Estimated completion is 2010-03.
What interventions are being tested in trial NCT00900731?
The interventions under investigation include: Placebo to indacaterol (DRUG), Indacaterol 150 μg (DRUG), Tiotropium 18 μg (DRUG), Placebo to tiotropium (DRUG).
Who is sponsoring clinical trial NCT00900731?
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 NCT00900731's enrollment target sits among peer trials
1,598 146th of 2000 higher than 1,855 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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