Comparison of New Combination Inhaler (FlutiForm HFA MDI 100/10 µg) Versus Fluticasone and Formoterol Administered Alone, and Placebo, in Patients With Asthma
Public ClinicalTrials.gov record NCT00393991. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-blind, Placebo-controlled, Parallel, Stratified, Multi-center, 12-Week Study Comparing the Safety & Efficacy of Fluticasone and Formoterol Combination (FlutiForm(tm)100/10 µg Twice Daily) in a Single Inhaler (SkyePharma HFA pMDI)With the Administration of Placebo or Fluticasone (100 µg Twice Daily) and Formoterol (10 µg Twice Daily) Alone in Adolescent and Adult Patients With Mild to Moderate Asthma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00393991
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 475 participants
Conditions and interventions
Conditions
Interventions
- Fluticasone propionate/formoterol fumarate 100/10 Drug
- Fluticasone propionate 100 Drug
- Formoterol fumarate 10 Drug
- Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 12 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 2006 (Type not available)
- Primary completion
- Apr 2008 (Actual)
- Completion
- Apr 2008 (Actual)
- Last update posted
- Jun 23, 2011
2006 – 2008
United States locations
- U.S. sites
- 47
- U.S. states
- 19
- U.S. cities
- 45
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Pell City | Alabama | 35128 | — |
| Research Site | Scottsdale | Arizona | 85251 | — |
| Research Site | Cypress | California | 90630 | — |
| Research Site | Encinitas | California | 92024 | — |
| Research Site | Fountain Valley | California | 92708 | — |
| Research Center | Los Angeles | California | 90048 | — |
| Research Site | Mission Hills | California | 91345 | — |
| Research Site | Centennial | Colorado | 80112 | — |
| Research Site | Colorado Springs | Colorado | 80907 | — |
| Research Site | Englewood | Colorado | 80112 | — |
| Research Site | Waterbury | Connecticut | 06708 | — |
| Research Site | Aventura | Florida | 33180 | — |
| Research Site | Gainesville | Florida | 32610 | — |
| Research Center | Largo | Florida | 33770 | — |
| Research Site | Miami | Florida | 33176 | — |
| Research Site | Ocala | Florida | 34471 | — |
| Research Site | Tallahassee | Florida | 32308 | — |
| Research Site | Conyers | Georgia | 30012 | — |
| Research Site | Lawrenceville | Georgia | 32308 | — |
| Research Site | Round Lake Beach | Illinois | 60073 | — |
| Research Site | Indianapolis | Indiana | 46208 | — |
| Research Site | Bethesda | Maryland | 20814 | — |
| Research Site | Brockton | Massachusetts | 02301 | — |
| Research Site | Cherry Hill | New Jersey | 08003 | — |
| Research Site | Forked River | New Jersey | 08732 | — |
| Research Site | Asheville | North Carolina | 28801 | — |
| Research Center | Elizabeth City | North Carolina | 27909 | — |
| Research Site | Elizabeth City | North Carolina | 27909 | — |
| Research Site | Columbus | Ohio | 43235 | — |
| Research Site | Toledo | Ohio | 43617 | — |
| Research Site | Okalahoma City | Oklahoma | 73139 | — |
| Research Site | Oklahoma City | Oklahoma | 73104 | — |
| Research Site | Oklahoma City | Oklahoma | 73112 | — |
| Research Site | Eugene | Oregon | 97401 | — |
| Research Site | Lake Oswego | Oregon | 97035 | — |
| Research Site | Medford | Oregon | 97504 | — |
| Research Site | Philadelphia | Pennsylvania | 19115 | — |
| Research Site | Pittsburgh | Pennsylvania | 15241 | — |
| Research Site | Scranton | Pennsylvania | 18509 | — |
| Research Site | Austin | Texas | 78750 | — |
| Research Site | Dallas | Texas | 75246 | — |
| Research Site | El Paso | Texas | 79925 | — |
| Research Site | Houston | Texas | 77024 | — |
| Research Site | McKinney | Texas | 75069 | — |
| Research Site | Round Rock | Texas | 78681 | — |
| Research Site | San Antonio | Texas | 78229 | — |
| Research Site | Bellingham | Washington | 98225 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 10 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00393991, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 23, 2011 · Synced Oct 17, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00393991 live on ClinicalTrials.gov.