Single-dose Crossover Study to Compare the Safety and Efficacy of FlutiForm With Fluticasone and Formoterol Concurrently or Alone in Asthma Patients
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
1 other identifier
interventional
64
2 countries
6
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 asthma
Started Oct 2004
Shorter than P25 for phase_2 asthma
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
January 26, 2009
CompletedFirst Posted
Study publicly available on registry
January 27, 2009
CompletedJune 23, 2011
June 1, 2011
3 months
January 26, 2009
June 8, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
pre-dose and at 5, 15, 30, 45, 60, 90 minutes and 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dose
Secondary Outcomes (1)
Treatment-emergent AEs, clinical laboratory data, 12-lead ECGs and vital signs
10 weeks including pre- and post-study assessments
Study Arms (6)
1
ACTIVE COMPARATOR* Period 1 Treatment Regimen A: FlutiForm 100/10 ug * Period 2 Treatment Regimen B: FlutiForm 250/10 ug * Period 3 Treatment Regimen C: Flixotide Evohaler 250 ug + Foradil Aerolizer 12 ug * Period 4 Treatment Regimen D: Flixotide Evohaler 250 ug
2
ACTIVE COMPARATOR* Period 1 Treatment Regimen D: Flixotide Evohaler 250 ug * Period 2 Treatment Regimen C: Flixotide Evohaler 250 ug + Foradil Aerolizer 12 ug * Period 3 Treatment Regimen B: FlutiForm 250/10 ug * Period 4 Treatment Regimen A: FlutiForm 100/10 ug
3
ACTIVE COMPARATOR* Period 1 Treatment Regimen B: FlutiForm 250/10 ug * Period 2 Treatment Regimen A: FlutiForm 100/10 ug * Period 3 Treatment Regimen F: Placebo * Period 4 Treatment Regimen E: Foradil Aerolizer 12 ug
4
ACTIVE COMPARATOR* Period 1 Treatment Regimen E: Foradil Aerolizer 12 ug * Period 2 Treatment Regimen F: Placebo * Period 3 Treatment Regimen A: FlutiForm 100/10 ug * Period 4 Treatment Regimen B: FlutiForm 250/10 ug
5
ACTIVE COMPARATOR* Period 1 Treatment Regimen C: Flixotide Evohaler 250 ug + Foradil Aerolizer 12 ug * Period 2 Treatment Regimen D: Flixotide Evohaler 250 ug * Period 3 Treatment Regimen E: Foradil Aerolizer 12 ug * Period 4 Treatment Regimen F: Placebo
6
ACTIVE COMPARATOR* Period 1 Treatment Regimen F: Placebo * Period 2 Treatment Regimen E: Foradil Aerolizer 12 ug * Period 3 Treatment Regimen D: Flixotide Evohaler 250 ug * Period 4 Treatment Regimen C: Flixotide Evohaler 250 ug + Foradil Aerolizer 12 ug
Interventions
* Period 1 Treatment Regimen E: Foradil Aerolizer 12 ug (One inhalation of formoterol 12 ug) * Period 2 Treatment Regimen F: Placebo (Two actuations of Placebo HFA pMDI * Period 3 Treatment Regimen A: FlutiForm 100/10 ug (Two actuations of fluticasone/formoterol HFA pMDI 50/5 ug/actuation) * Period 4 Treatment Regimen B: FlutiForm 250/10 ug (Two actuations of fluticasone/formoterol HFA pMDI 125/5 ug/actuation)
Eligibility Criteria
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:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SkyePharma AGlead
Study Sites (6)
Investigational site
Belfast, Ireland
Investigational site
Derbyshire, United Kingdom
Investigational site
London, United Kingdom
Investigational site
Manchester, United Kingdom
Investigational site
Plymouth, United Kingdom
Investigational site
Slough, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
SKP
SkyePharma AG
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 26, 2009
First Posted
January 27, 2009
Study Start
October 1, 2004
Primary Completion
January 1, 2005
Study Completion
January 1, 2005
Last Updated
June 23, 2011
Record last verified: 2011-06