Single-dose Crossover Study to Compare the Safety and Efficacy of FlutiForm With Fluticasone and Formoterol Concurrently or Alone in Asthma Patients
June 8, 2011 updated by: SkyePharma AG
A Randomized, Placebo-controlled, Double-blind, Six-way Crossover, Single-dose Exposure Study to Compare the Safety and Efficacy of Fluticasone and Formoterol Combination (FlutiForm™100/10μg and 250/10μg) in a Single Inhaler (SkyePharma HFA MDI) With the Administration of Fluticasone (250μg) and Formoterol (12μg) Concurrently or Alone in Patients With Asthma
The primary purpose was to evaluate the efficacy of SKP FlutiForm HFA MDI compared to placebo or fluticasone and formoterol administered concurrently or alone in asthma patients.
Study Overview
Status
Status
Completed
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Interventional
Enrollment (Actual)
Enrollment
64
Phase
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Belfast, Ireland
- Investigational Site
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Derbyshire, United Kingdom
- Investigational Site
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London, United Kingdom
- Investigational Site
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Manchester, United Kingdom
- Investigational Site
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Plymouth, United Kingdom
- Investigational Site
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Slough, United Kingdom
- Investigational Site
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subjects with documented history of mild to moderate asthma currently taking a stable dose of inhaled corticosteroid
Exclusion Criteria:
- Smoking history within the last 12 months
- No history of respiratory tract infection within 4 weeks
- No history or evidence of any clinically significant disease or abnormality
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Number of Arms
6
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
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ACTIVE_COMPARATOR: 1
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ACTIVE_COMPARATOR: 2
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ACTIVE_COMPARATOR: 3
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ACTIVE_COMPARATOR: 4
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ACTIVE_COMPARATOR: 5
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ACTIVE_COMPARATOR: 6
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change from Baseline in Actual FEV1, % change from Baseline in Actual FEV1, change from Baseline in FEV1 % predicted normal, FEV1 max and FEV1 AUC above the Baseline
Time Frame: pre-dose and at 5, 15, 30, 45, 60, 90 minutes and 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dose
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pre-dose and at 5, 15, 30, 45, 60, 90 minutes and 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dose
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Treatment-emergent AEs, clinical laboratory data, 12-lead ECGs and vital signs
Time Frame: 10 weeks including pre- and post-study assessments
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10 weeks including pre- and post-study assessments
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Sponsor
Investigators
Investigators
- Study Director: SKP, SkyePharma AG
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
Study Start
October 1, 2004
Primary Completion (ACTUAL)
Primary Completion
January 1, 2005
Study Completion (ACTUAL)
Study Completion
January 1, 2005
Study Registration Dates
First Submitted
First Submitted
January 26, 2009
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
January 26, 2009
First Posted (ESTIMATE)
First Posted
January 27, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Posted
June 23, 2011
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
June 8, 2011
Last Verified
Last Verified
June 1, 2011
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
Other Study ID Numbers
- SKY2028-2-001
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.