- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00734292
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
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
-
Anaheim, California, United States, 92801
- Investigational Site
-
Mission Viejo, California, United States, 92691
- Investigational Site
-
-
Colorado
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Denver, Colorado, United States, 80230
- Investigational Site
-
-
Florida
-
Valrico, Florida, United States, 33594
- Investigational Site
-
-
Oregon
-
Medford, Oregon, United States, 97504
- Investigational Site
-
Portland, Oregon, United States, 97213
- Investigational Site
-
-
Virginia
-
Richmond, Virginia, United States, 23229
- Investigational Site
-
-
Wisconsin
-
West Allis, Wisconsin, United States, 53227
- Investigational Site
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: I
|
● 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 Names:
|
Placebo Comparator: II
|
● 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)
Other Names:
● 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)
Other Names:
|
Placebo Comparator: III
|
● 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)
Other Names:
● 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)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline FEV1 to post study drug dosing FEV1
Time Frame: 3 minutes
|
3 minutes
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline FEV1 to post study drug dosing FEV1
Time Frame: 8, 15, 30, and 60 minutes
|
8, 15, 30, and 60 minutes
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Asthma
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Adrenergic Agonists
- Dermatologic Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Anti-Allergic Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Fluticasone
- Xhance
- Formoterol Fumarate
Other Study ID Numbers
- SKY2028-2-002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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