Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01845025 · ClinicalTrials.gov registry record · Phase 4
Study of Safety of Foradil in Patients With Persistent Asthma
A Phase 4 study, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- Phase 4
- Development phase
- 827
- Enrollment target
NCT01845025: Clinical Trial Phase 4 study, sponsored by Novartis Pharmaceuticals.
NCT01845025 is a Phase 4 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 827 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (60% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01845025, a Phase 4 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 827 participants
- Enrollment target
Study Summary
The purpose of this study was to assess whether the risk of serious asthma-related events (asthma-related hospitalizations, asthma related intubations, and asthma related deaths) in adolescents and adults (12 years of age and older) taking inhaled formoterol fumarate/fluticasone propionate combination was the same as those taking inhaled fluticasone propionate alone.
Primary Outcome
The primary safety endpoint was the number of first occurrence(s) of any composite endpoint. The composite events include asthma-related deaths, asthma-related intubations and asthma-related hospitalizations. The number of events includes all adjudication confirmed events, one patient could experience multiple events during the course of study; Event rate = 100 \* n patients with any events / total N patients in treatment group.
Interventions
- DRUG Placebo
- DRUG Fluticasone propionate 250 mcg
- DRUG Formoterol 12 mcg
- DRUG Fluticasone propionate 100 mcg
- DRUG Fluticasone propionate 500 mcg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 827 participants |
| Start Date | 2013-05 |
| Est. Completion | 2016-05 |
| Phase | Phase 4 |
Why NCT01845025 stopped before completion
NCT01845025 is an interventional study that assigns participants to a tested intervention. The registered 827 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (60% higher).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT01845025 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01845025 about?
NCT01845025 is a clinical study titled "Study of Safety of Foradil in Patients With Persistent Asthma". The purpose of this study was to assess whether the risk of serious asthma-related events (asthma-related hospitalizations, asthma related intubations, and asthma related deaths) in adolescents and adults (12 years of age and older) taking inhaled formoterol fumarate/fluticasone propionate combinati...
What is the current status of trial NCT01845025?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 827 participants. The study started on 2013-05. Estimated completion is 2016-05.
What interventions are being tested in trial NCT01845025?
The interventions under investigation include: Placebo (DRUG), Fluticasone propionate 250 mcg (DRUG), Formoterol 12 mcg (DRUG), Fluticasone propionate 100 mcg (DRUG), Fluticasone propionate 500 mcg (DRUG).
Who is sponsoring clinical trial NCT01845025?
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 NCT01845025's enrollment target sits among peer trials
827 93rd of 2000 higher than 1,908 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03547973 · 827 participants · Phase 2
Study of Sacituzumab Govitecan in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread
- NCT05124808 · 828 participants · NA
Intensive Glycemic Targets in Overweight and Obese Women With Gestational Diabetes
- NCT05630482 · 825 participants · NA
Randomized Trial of Healthy Family Foundations
- NCT06097728 · 825 participants · Phase 3
MEDI5752 in Combination With Carboplatin Plus Pemetrexed in Unresectable Pleural Mesothelioma
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia