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NCT01444430 · ClinicalTrials.gov registry record · Phase 3
A 6 Month Safety Study Comparing Symbicort With Inhaled Corticosteroid Only in Asthmatic Adults and Adolescents
A Phase 3 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 12,460
- Enrollment target
NCT01444430: Completed Phase 3 study, sponsored by AstraZeneca.
NCT01444430 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 12,460 participants, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (1516% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01444430, a Phase 3 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 12,460 participants
- Enrollment target
Study Summary
The purpose of the study is to evaluate the safety of Symbicort compared to inhaled corticosteroid alone during 6 months in adult and adolescent patients with asthma
Primary Outcome
Number of participants experiencing an event in the composite endpoint (asthma-related death, asthma-related intubation or asthma-related hospitalization), using events adjudicated and confirmed by the Joint Adjudication Committee. Cox proportional hazards model with terms for randomized treatment and strata for incoming control/asthma treatment was used to compare Symbicort and budesonide. Hazard ratios and 95% confidence intervals were estimated.
Interventions
- DRUG Symbicort pMDI
- DRUG budesonide pMDI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12,460 participants |
| Start Date | 2011-12 |
| Est. Completion | 2015-10 |
| Phase | Phase 3 |
What the finished NCT01444430 record still lists
NCT01444430 is an interventional study that assigns participants to a tested intervention. Its 12,460 participants enrollment target places it among the larger protocols in the corpus, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (1516% higher).
The record links to 0 conditions, and to 2 interventions - of which Symbicort pMDI is the first listed.
NCT01444430 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01444430 about?
NCT01444430 is a clinical study titled "A 6 Month Safety Study Comparing Symbicort With Inhaled Corticosteroid Only in Asthmatic Adults and Adolescents". The purpose of the study is to evaluate the safety of Symbicort compared to inhaled corticosteroid alone during 6 months in adult and adolescent patients with asthma
What is the current status of trial NCT01444430?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 12,460 participants. The study started on 2011-12. Estimated completion is 2015-10.
What interventions are being tested in trial NCT01444430?
The interventions under investigation include: Symbicort pMDI (DRUG), budesonide pMDI (DRUG).
Who is sponsoring clinical trial NCT01444430?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01444430's enrollment target sits among peer trials
12,460 20th of 2000 higher than 1,981 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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