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NCT01025648 · ClinicalTrials.gov registry record · Phase 1
Randomized, Placebo/Active Crossover Dose-ranging Study for Safety and Efficacy in Asthma Patients.
A Phase 1 study, sponsored by Amphastar Pharmaceuticals.
- Terminated
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT01025648 is a Phase 1 study that was terminated before completion, run by Amphastar Pharmaceuticals. The registered enrollment target is 9 participants.
The verdict
NCT01025648, a Phase 1 study, was terminated before completion, sponsored by Amphastar Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
The main objective of this study is to evaluate the efficacy and safety of the Armstrong's Epinephrine HFA-MDI (E004) formulation, in comparison to the Placebo (Placebo-HFA) and an Active Control (Epinephrine CFC-MDI), and to identify the optimum E004 dose strength(s) for the ensuing pivotal clinical trials. The study will be conducted in adult patients who have intermittent, or mild-to-moderate persistent, asthma, but are otherwise healthy. The bronchodilatory efficacy of E004, is evaluated in terms of post-dose area under the curves (AUC) of FEV1 changes (% and volumes), from the pre-dose baseline values, in comparison to the Placebo Control and the Active Control.
Interventions
- DRUG E004 (epinephrine inhalation aerosol), 90 mcg/actuation
- DRUG E004 Placebo
- DRUG E004 (epinephrine inhalation aerosol), 125 mcg
- DRUG E004 (epinephrine inhalation aerosol), 220 mcg
- DRUG epinephrine inhalation aerosol, CFC propelled
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2009-12 |
| Est. Completion | 2009-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01025648
The ClinicalTrials.gov registry entry for NCT01025648 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amphastar Pharmaceuticals, which has 21 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which E004 (epinephrine inhalation aerosol), 90 mcg/actuation is the first listed.
NCT01025648 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01025648 about?
NCT01025648 is a clinical study titled "Randomized, Placebo/Active Crossover Dose-ranging Study for Safety and Efficacy in Asthma Patients.". The main objective of this study is to evaluate the efficacy and safety of the Armstrong's Epinephrine HFA-MDI (E004) formulation, in comparison to the Placebo (Placebo-HFA) and an Active Control (Epinephrine CFC-MDI), and to identify the optimum E004 dose strength(s) for the ensuing pivotal clinica...
What is the current status of trial NCT01025648?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2009-12. Estimated completion is 2009-12.
What interventions are being tested in trial NCT01025648?
The interventions under investigation include: E004 (epinephrine inhalation aerosol), 90 mcg/actuation (DRUG), E004 Placebo (DRUG), E004 (epinephrine inhalation aerosol), 125 mcg (DRUG), E004 (epinephrine inhalation aerosol), 220 mcg (DRUG), epinephrine inhalation aerosol, CFC propelled (DRUG).
Who is sponsoring clinical trial NCT01025648?
This trial is sponsored by Amphastar Pharmaceuticals, which has 21 total clinical trials registered on ClinicalTrials.gov.
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