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NCT01576718 · ClinicalTrials.gov registry record · Phase 2
A Study of the Effectiveness and Safety of Different Doses of Fluticasone Propionate Taken From a Dry Powder Inhaler (Puffer) in Adolescents and Adults Who Have Asthma That is Not Controlled by High Dose Inhaled Corticosteroid Asthma Medications
A Phase 2 study, sponsored by Teva Branded Pharmaceutical Products R&D.
- Completed
- Registry status
- Phase 2
- Development phase
- 889
- Enrollment target
NCT01576718 is a Phase 2 study that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 889 participants.
The verdict
NCT01576718, a Phase 2 study, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 889 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the dose response, efficacy and safety of 4 different doses of fluticasone propionate (50, 100, 200, and 400mcg) delivered as Fluticasone Spiromax® Inhalation Powder (Fp Spiromax) when administered twice daily in subjects 12 years of age and older with severe persistent asthma who are uncontrolled on high dose ICS therapy.
Interventions
- DRUG Fp MDPI
- DRUG albuterol/salbutamol
- DRUG Flovent Diskus
- OTHER Placebo MDPI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 889 participants |
| Start Date | 2012-04 |
| Est. Completion | 2013-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01576718
The ClinicalTrials.gov registry entry for NCT01576718 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 889 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Teva Branded Pharmaceutical Products R&D, which has 167 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Fp MDPI is the first listed.
NCT01576718 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01576718 about?
NCT01576718 is a clinical study titled "A Study of the Effectiveness and Safety of Different Doses of Fluticasone Propionate Taken From a Dry Powder Inhaler (Puffer) in Adolescents and Adults Who Have Asthma That is Not Controlled by High Dose Inhaled Corticosteroid Asthma Medications". The primary objective of this study is to evaluate the dose response, efficacy and safety of 4 different doses of fluticasone propionate (50, 100, 200, and 400mcg) delivered as Fluticasone Spiromax® Inhalation Powder (Fp Spiromax) when administered twice daily in subjects 12 years of age and older w...
What is the current status of trial NCT01576718?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 889 participants. The study started on 2012-04. Estimated completion is 2013-10.
What interventions are being tested in trial NCT01576718?
The interventions under investigation include: Fp MDPI (DRUG), albuterol/salbutamol (DRUG), Flovent Diskus (DRUG), Placebo MDPI (OTHER).
Who is sponsoring clinical trial NCT01576718?
This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.
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