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NCT03257995 · ClinicalTrials.gov registry record · Phase 2
Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Two Orally Inhaled Indacaterol Salts in Adult Subjects With Asthma.
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 54
- Enrollment target
NCT03257995: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT03257995 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 54 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03257995, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 54 participants
- Enrollment target
Study Summary
This study is a randomized, double-blind, placebo-controlled, three-period cross-over study in approximately 54 subjects with asthma.
Primary Outcome
FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of forced exhalation. Treatment differences in trough FEV1 after 14 days of treatment between indacaterol maleate 150 μg and placebo, between indacaterol acetate 150 μg and placebo and indacaterol maleate and indacaterol acetate
Interventions
- DRUG Placebo
- DRUG Indacaterol maleate
- DRUG Indacaterol acetate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2017-09-05 |
| Est. Completion | 2018-01-18 |
| Phase | Phase 2 |
What the finished NCT03257995 record still lists
NCT03257995 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03257995 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03257995 about?
NCT03257995 is a clinical study titled "Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Two Orally Inhaled Indacaterol Salts in Adult Subjects With Asthma.". This study is a randomized, double-blind, placebo-controlled, three-period cross-over study in approximately 54 subjects with asthma.
What is the current status of trial NCT03257995?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 54 participants. The study started on 2017-09-05. Estimated completion is 2018-01-18.
What interventions are being tested in trial NCT03257995?
The interventions under investigation include: Placebo (DRUG), Indacaterol maleate (DRUG), Indacaterol acetate (DRUG).
Who is sponsoring clinical trial NCT03257995?
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 NCT03257995's enrollment target sits among peer trials
54 1160th of 2000 higher than 830 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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