Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00393991 · ClinicalTrials.gov registry record · Phase 3
Comparison of New Combination Inhaler (FlutiForm HFA MDI 100/10 µg) Versus Fluticasone and Formoterol Administered Alone, and Placebo, in Patients With Asthma
A Phase 3 study, sponsored by SkyePharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 475
- Enrollment target
NCT00393991: Completed Phase 3 study, sponsored by SkyePharma.
NCT00393991 is a Phase 3 study that has completed, run by SkyePharma. The registered enrollment target is 475 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00393991, a Phase 3 study, has completed, sponsored by SkyePharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 475 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the efficacy and safety of the fixed combination asthma drug FlutiForm HFA MDI with its two components administered alone, fluticasone propionate and formoterol fumarate, and with placebo in adult and adolescent patients with mild to moderate asthma.
Interventions
- DRUG Placebo
- DRUG Formoterol fumarate 10
- DRUG Fluticasone propionate 100
- DRUG Fluticasone propionate/formoterol fumarate 100/10
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 475 participants |
| Start Date | 2006-07 |
| Est. Completion | 2008-04 |
| Phase | Phase 3 |
What the finished NCT00393991 record still lists
NCT00393991 is an interventional study that assigns participants to a tested intervention. The registered 475 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (38% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT00393991 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00393991 about?
NCT00393991 is a clinical study titled "Comparison of New Combination Inhaler (FlutiForm HFA MDI 100/10 µg) Versus Fluticasone and Formoterol Administered Alone, and Placebo, in Patients With Asthma". The purpose of this study is to compare the efficacy and safety of the fixed combination asthma drug FlutiForm HFA MDI with its two components administered alone, fluticasone propionate and formoterol fumarate, and with placebo in adult and adolescent patients with mild to moderate asthma.
What is the current status of trial NCT00393991?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 475 participants. The study started on 2006-07. Estimated completion is 2008-04.
What interventions are being tested in trial NCT00393991?
The interventions under investigation include: Placebo (DRUG), Formoterol fumarate 10 (DRUG), Fluticasone propionate 100 (DRUG), Fluticasone propionate/formoterol fumarate 100/10 (DRUG).
Who is sponsoring clinical trial NCT00393991?
This trial is sponsored by SkyePharma, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00393991's enrollment target sits among peer trials
475 808th of 2000 higher than 1,191 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01788839 · 475 participants
Longitudinal Sexual and Reproductive Health Study of Women With Breast Cancer and Lymphoma
- NCT05451303 · 475 participants
Detection of Oral and Throat Cancers Using OralViome Cancer Testing System
- NCT06892379 · 475 participants · Phase 1
A Study of HS-20110 in Participants With Advanced Solid Tumors
- NCT06754046 · 476 participants · NA
BELIEVE Trial: Bulking vErsus sLing for Treating Stress Urinary IncontinEnce at the Time of Vaginal prolapsE Repair (BELIEVE)
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia