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

NCT00734292 | Completed Phase 2

• 1 other identifier: SKY2028-2-002
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 8

Brief Summary

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

Conditions

Mild to Moderate Asthma

Keywords

Asthma; Asthma Mild to Moderate

Outcome Measures

Primary Outcomes (1)

• Change from baseline FEV1 to post study drug dosing FEV1

  3 minutes

Secondary Outcomes (1)

• Change from baseline FEV1 to post study drug dosing FEV1

  8, 15, 30, and 60 minutes

Study Arms (3)

I

PLACEBO COMPARATOR

* Period 1 Treatment Regimen A: FlutiForm 250/10 ug * Period 2 Treatment Regimen B: FlutiForm 100/10 ug * Period 3 Treatment Regimen C: placebo

Drug: fluticasone propionate, formoterol fumarate

II

PLACEBO COMPARATOR

* Period 1 Treatment Regimen B: FlutiForm 100/10 ug * Period 2 Treatment Regimen C: placebo * Period 3 Treatment Regimen A: FlutiForm 250/10 ug

Other: fluticasone propionate, formoterol fumarate

III

PLACEBO COMPARATOR

* Period 1 Treatment Regimen C: placebo * Period 2 Treatment Regimen A: FlutiForm 250/10 ug * Period 3 Treatment Regimen B: FlutiForm 100/10 ug

Other: fluticasone propionate, formoterol fumarate

Interventions

fluticasone propionate, formoterol fumarate DRUG

● 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)

Also known as: FlutiForm

I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• SkyePharma AG: lead
• Abbott: collaborator

Study Sites (8)

Investigational Site

Anaheim, California, 92801, United States

Location

Investigational Site

Mission Viejo, California, 92691, United States

Location

Investigational Site

Denver, Colorado, 80230, United States

Location

Investigational Site

Valrico, Florida, 33594, United States

Location

Investigational Site

Medford, Oregon, 97504, United States

Location

Investigational Site

Portland, Oregon, 97213, United States

Location

Investigational Site

Richmond, Virginia, 23229, United States

Location

Investigational Site

West Allis, Wisconsin, 53227, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Fluticasone; Formoterol Fumarate; fluticasone-formoterol

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 4, 2008
• First Posted: August 14, 2008
• Study Start: September 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: October 1, 2008
• Last Updated: August 27, 2010

Record last verified: 2010-08

Locations

US (8)