Single-dose Crossover Study to Compare the Safety and Efficacy of FlutiForm With Fluticasone and Formoterol Concurrently or Alone in Asthma Patients

A Randomized, Placebo-controlled, Double-blind, Six-way Crossover, Single-dose Exposure Study to Compare the Safety and Efficacy of Fluticasone and Formoterol Combination (FlutiForm™100/10μg and 250/10μg) in a Single Inhaler (SkyePharma HFA MDI) With the Administration of Fluticasone (250μg) and Formoterol (12μg) Concurrently or Alone in Patients With Asthma

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00830102

Enrollment

Registered

2009-01-27

Start date

2004-10-31

Completion date

2005-01-31

Last updated

2011-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Mild to Moderate Asthma

Brief summary

The primary purpose was to evaluate the efficacy of SKP FlutiForm HFA MDI compared to placebo or fluticasone and formoterol administered concurrently or alone in asthma patients.

Interventions

DRUGfluticasone propionate, formoterol fumarate

* Period 1 Treatment Regimen E: Foradil Aerolizer 12 ug (One inhalation of formoterol 12 ug) * Period 2 Treatment Regimen F: Placebo (Two actuations of Placebo HFA pMDI * Period 3 Treatment Regimen A: FlutiForm 100/10 ug (Two actuations of fluticasone/formoterol HFA pMDI 50/5 ug/actuation) * Period 4 Treatment Regimen B: FlutiForm 250/10 ug (Two actuations of fluticasone/formoterol HFA pMDI 125/5 ug/actuation)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Subjects with documented history of mild to moderate asthma currently taking a stable dose of inhaled corticosteroid

Exclusion criteria

* Smoking history within the last 12 months * No history of respiratory tract infection within 4 weeks * No history or evidence of any clinically significant disease or abnormality

Design outcomes

Primary

Measure	Time frame
Change from Baseline in Actual FEV1, % change from Baseline in Actual FEV1, change from Baseline in FEV1 % predicted normal, FEV1 max and FEV1 AUC above the Baseline	pre-dose and at 5, 15, 30, 45, 60, 90 minutes and 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dose

Secondary

Measure	Time frame
Treatment-emergent AEs, clinical laboratory data, 12-lead ECGs and vital signs	10 weeks including pre- and post-study assessments

Countries

Ireland, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026