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

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

Official Title
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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

Conditions
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Mild to Moderate Asthma

Intervention / Treatment
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* Drug: fluticasone propionate, formoterol fumarate
* Other: fluticasone propionate, formoterol fumarate
* Other: fluticasone propionate, formoterol fumarate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: I<br>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<br>* ● 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)<br>* Other names: FlutiForm;|
| Placebo Comparator: II<br>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<br>* ● 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)<br>* Other names: FlutiForm;|
| Placebo Comparator: III<br>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<br>* ● 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)<br>* Other names: FlutiForm;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline FEV1 to post study drug dosing FEV1 |  | 3 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline FEV1 to post study drug dosing FEV1 |  | 8, 15, 30, and 60 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, Asthma Mild to Moderate