Single-dose Crossover Study to Evaluate the Early Bronchodilating Effect of FlutiForm HFA pMDI in Adult Subjects With Mild to Moderate Asthma

A Randomized, Placebo-controlled, Double-blind, Crossover, Single-dose Exposure Study to Evaluate the Early Bronchodilating Effect of FlutiForm 100/10 µg HFA pMDI and FlutiForm 250/10 µg HFA pMDI, Compared to Placebo in Adult Subjects With Mild to Moderate Asthma

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00734292

Enrollment

Registered

2008-08-14

Start date

2008-09-30

Completion date

2008-10-31

Last updated

2010-08-27

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

Conditions

Mild to Moderate Asthma

Keywords

Asthma, Asthma Mild to Moderate

Brief summary

The primary purpose of this study is to evaluate the early bronchodilating effect of SKP FlutiForm HFA pMDI compared to placebo.

Interventions

DRUGfluticasone propionate, formoterol fumarate

● Period 1 Treatment Regimen A: FlutiForm 250/10 ug FlutiForm HFA pMDI (250/10 ug); (two actuations of FlutiForm HFA pMDI 125/5 ug/actuation) ● Period 2 Treatment Regimen B: FlutiForm 100/10 ug FlutiForm HFA pMDI (100/10 ug); (two actuations of FlutiForm HFA pMDI 50/5 ug/actuation) ● Period 3 Treatment Regimen C: placebo SKP placebo; (two actuations)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Participation in a prior FlutiForm study * Smoking history within the last 12 months, * Significant, non-reversible, pulmonary disease * Life-threatening asthma within the last year

Design outcomes

Primary

Measure	Time frame
Change from baseline FEV1 to post study drug dosing FEV1	3 minutes

Secondary

Measure	Time frame
Change from baseline FEV1 to post study drug dosing FEV1	8, 15, 30, and 60 minutes

Countries

United States

Outcome results

None listed

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