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NCT03944707 · ClinicalTrials.gov registry record · Phase 2
Study of Efficacy and Safety of LOU064 in Inadequately Controlled Asthma Patients
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- Phase 2
- Development phase
- 76
- Enrollment target
NCT03944707: Clinical Trial Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT03944707 is a Phase 2 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 76 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03944707, a Phase 2 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 76 participants
- Enrollment target
Study Summary
This was a proof-of-concept study to evaluate the efficacy of LOU064 in patients with inadequately controlled asthma. All subjects were randomized with 3:2 ratio to receive LOU064 100 mg once daily or LOU064 matching placebo for 12 weeks with standard background therapy of budesonide 80 µg/formoterol 4.5 µg two inhalations twice a day (b.i.d).
Primary Outcome
FEV1 (forced expiratory volume in one second) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. Pre-dose FEV1 is defined as average of the two FEV1 measurements taken 45 min and 15 min pre-dose. The baseline pre-dose FEV1 is defined as the average of the FEV1 measurements performed 45 min and 15 min prior to dosing on Day 1. A positive change from baseline in pre-dose FEV1 is considered a favorable
Interventions
- DRUG Placebo
- DRUG LOU064 100 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2019-07-18 |
| Est. Completion | 2020-04-27 |
| Phase | Phase 2 |
Why NCT03944707 stopped before completion
NCT03944707 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03944707 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03944707 about?
NCT03944707 is a clinical study titled "Study of Efficacy and Safety of LOU064 in Inadequately Controlled Asthma Patients". This was a proof-of-concept study to evaluate the efficacy of LOU064 in patients with inadequately controlled asthma. All subjects were randomized with 3:2 ratio to receive LOU064 100 mg once daily or LOU064 matching placebo for 12 weeks with standard background therapy of budesonide 80 µg/formotero...
What is the current status of trial NCT03944707?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 76 participants. The study started on 2019-07-18. Estimated completion is 2020-04-27.
What interventions are being tested in trial NCT03944707?
The interventions under investigation include: Placebo (DRUG), LOU064 100 mg (DRUG).
Who is sponsoring clinical trial NCT03944707?
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 NCT03944707's enrollment target sits among peer trials
76 893rd of 2000 higher than 1,101 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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