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NCT04545385 · ClinicalTrials.gov registry record · Phase 2
A Study to Test if TEV-48574 is Effective in Relieving Asthma
A Phase 2 study, sponsored by Teva Branded Pharmaceutical Products R&D.
- Terminated
- Registry status
- Phase 2
- Development phase
- 65
- Enrollment target
NCT04545385: Clinical Trial Phase 2 study, sponsored by Teva Branded Pharmaceutical Products R&D.
NCT04545385 is a Phase 2 study that was terminated before completion, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 65 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (51% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04545385, a Phase 2 study, was terminated before completion, sponsored by Teva Branded Pharmaceutical Products R&D.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 65 participants
- Enrollment target
Study Summary
The primary objective of the study is to evaluate the effect of TEV-48574 compared with placebo on loss of asthma control (LoAC) in adult participants with T2-low and non-T2 severe asthma uncontrolled on inhaled corticosteroids plus long-acting beta-agonists (ICS+LABA). The secondary efficacy objective is to evaluate the effect of TEV-48574 compared with placebo on a range of clinical measures of asthma control. The duration of participant participation in the study is planned to be up to approximately 30 weeks.
Primary Outcome
The LoAC was defined as any 1 of the following during the treatment period: - morning peak expiratory flow (PEF) decrease ≥30% from baseline on 2 consecutive days or morning handheld forced expiratory volume in the first second of exhalation (FEV1) decrease ≥20% from baseline on 2 consecutive days; - increase in short-acting beta-agonist (SABA)/quick-relief medication ≥6 puffs over baseline use in 24 hours on 2 consecutive days; increase in inhaled corticosteroids (ICS) dose ≥4 × most recent dos
Interventions
- DRUG Placebo
- DRUG TEV-48574
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2020-10-07 |
| Est. Completion | 2022-01-17 |
| Phase | Phase 2 |
Why NCT04545385 stopped before completion
NCT04545385 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (51% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04545385 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04545385 about?
NCT04545385 is a clinical study titled "A Study to Test if TEV-48574 is Effective in Relieving Asthma". The primary objective of the study is to evaluate the effect of TEV-48574 compared with placebo on loss of asthma control (LoAC) in adult participants with T2-low and non-T2 severe asthma uncontrolled on inhaled corticosteroids plus long-acting beta-agonists (ICS+LABA). The secondary efficacy objec...
What is the current status of trial NCT04545385?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 65 participants. The study started on 2020-10-07. Estimated completion is 2022-01-17.
What interventions are being tested in trial NCT04545385?
The interventions under investigation include: Placebo (DRUG), TEV-48574 (DRUG).
Who is sponsoring clinical trial NCT04545385?
This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04545385's enrollment target sits among peer trials
65 987th of 2000 higher than 1,005 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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