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

Mild to Moderate Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00734292
• Other study ID #: SKY2028-2-002
• Status: Completed
• Phase: Phase 2
• First received: August 4, 2008
• Last updated: August 24, 2010
• Start date: September 2008
• Est. completion date: October 2008

Study information

• Verified date: August 2010
• Source: SkyePharma AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: October 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Asthma
• Mild to Moderate Asthma

Intervention

Drug:
• fluticasone 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)

Other:
• fluticasone propionate, formoterol fumarate
? Period 1 Treatment Regimen B: FlutiForm 100/10 ug FlutiForm HFA pMDI (100/10 ug); (two actuations of FlutiForm HFA pMDI 50/5 ug/actuation) ? Period 2 Treatment Regimen C: placebo SKP placebo; (two actuations) ? Period 3 Treatment Regimen A: FlutiForm 250/10 ug FlutiForm HFA pMDI (250/10 ug); (two actuations of FlutiForm HFA pMDI 125/5 ug/actuation)
• fluticasone propionate, formoterol fumarate
? Period 1 Treatment Regimen C: placebo SKP placebo; (two actuations) ? Period 2 Treatment Regimen A: FlutiForm 250/10 ug FlutiForm HFA pMDI (250/10 ug); (two actuations of FlutiForm HFA pMDI 125/5 ug/actuation) ? Period 3 Treatment Regimen B: FlutiForm 100/10 ug FlutiForm HFA pMDI (100/10 ug); (two actuations of FlutiForm HFA pMDI 50/5 ug/actuation)

Locations

Country	Name	City	State
United States	Investigational Site	Anaheim	California
United States	Investigational Site	Denver	Colorado
United States	Investigational Site	Medford	Oregon
United States	Investigational Site	Mission Viejo	California
United States	Investigational Site	Portland	Oregon
United States	Investigational Site	Richmond	Virginia
United States	Investigational Site	Valrico	Florida
United States	Investigational Site	West Allis	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
SkyePharma AG	Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline FEV1 to post study drug dosing FEV1		3 minutes	No
Secondary	Change from baseline FEV1 to post study drug dosing FEV1		8, 15, 30, and 60 minutes	No