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Single-dose Crossover Study to Compare the Safety and Efficacy of FlutiForm With Fluticasone and Formoterol Concurrently or Alone in Asthma Patients

Primary Purpose

Asthma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
fluticasone propionate, formoterol fumarate
fluticasone propionate, formoterol fumarate
fluticasone propionate, formoterol fumarate
fluticasone propionate, formoterol fumarate
fluticasone propionate, formoterol fumarate
fluticasone propionate, formoterol fumarate
Sponsored by
SkyePharma AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Mild to Moderate Asthma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Investigational site
  • Investigational site
  • Investigational site
  • Investigational site
  • Investigational site
  • Investigational site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

1

2

3

4

5

6

Arm Description

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Treatment-emergent AEs, clinical laboratory data, 12-lead ECGs and vital signs

Full Information

First Posted
January 26, 2009
Last Updated
June 8, 2011
Sponsor
SkyePharma AG
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1. Study Identification

Unique Protocol Identification Number
NCT00830102
Brief Title
Single-dose Crossover Study to Compare the Safety and Efficacy of FlutiForm With Fluticasone and Formoterol Concurrently or Alone in Asthma Patients
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
January 2005 (Actual)
Study Completion Date
January 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
SkyePharma AG

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Mild to Moderate Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
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
Arm Title
2
Arm Type
Active Comparator
Arm Description
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
Arm Title
3
Arm Type
Active Comparator
Arm Description
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
Arm Title
4
Arm Type
Active Comparator
Arm Description
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
Arm Title
5
Arm Type
Active Comparator
Arm Description
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
Arm Title
6
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
fluticasone propionate, formoterol fumarate
Other Intervention Name(s)
FlutiForm
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
fluticasone propionate, formoterol fumarate
Other Intervention Name(s)
FlutiForm
Intervention Description
Period 1 Treatment Regimen D: Flixotide Evohaler 250 ug (Two actuations of fluticasone HFA pMDI 125ug/actuation) Period 2 Treatment Regimen C: Flixotide Evohaler 250 ug + Foradil Aerolizer 12 ug (Two actuations of fluticasone HFA pMDI 125ug/actuation and one inhalation of formoterol DPI 12ug/inhalation) Period 3 Treatment Regimen B: FlutiForm 250/10 ug (Two actuations of fluticasone/formoterol HFA pMDI 125/5 ug/actuation) Period 4 Treatment Regimen A: FlutiForm 100/10 ug (Two actuations of fluticasone/formoterol HFA pMDI 50/5 ug/actuation)
Intervention Type
Drug
Intervention Name(s)
fluticasone propionate, formoterol fumarate
Other Intervention Name(s)
FlutiForm
Intervention Description
Period 1 Treatment Regimen B: FlutiForm 250/10 ug (Two actuations of fluticasone/formoterol HFA pMDI 125/5 ug/actuation) Period 2 Treatment Regimen A: FlutiForm 100/10 ug (Two actuations of fluticasone/formoterol HFA pMDI 50/5 ug/actuation) Period 3 Treatment Regimen F: Placebo (Two actuations of placebo HFA pMDI) Period 4 Treatment Regimen E: Foradil Aerolizer 12 ug (One inhalation of formoterol DPI 12 ug)
Intervention Type
Drug
Intervention Name(s)
fluticasone propionate, formoterol fumarate
Other Intervention Name(s)
FlutiForm
Intervention Description
Period 1 Treatment Regimen E: Foradil Aerolizer 12 ug (One inhalation of formoterol DPI 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)
Intervention Type
Drug
Intervention Name(s)
fluticasone propionate, formoterol fumarate
Other Intervention Name(s)
FlutiForm
Intervention Description
Period 1 Treatment Regimen C: Flixotide Evohaler 250 ug + Foradil Aerolizer 12 ug (Two actuations of fluticasone HFA pMDI 125ug/actuation and one inhalation of formoterol DPI 12ug/inhalation) Period 2 Treatment Regimen D: Flixotide Evohaler 250 ug (Two actuations of fluticasone HFA pMDI 125 ug/actuation) Period 3 Treatment Regimen E: Foradil Aerolizer 12 ug (One inhalation of formoterol DPI 12 ug) Period 4 Treatment Regimen F: Placebo (Two actuations of Placebo HFA pMDI)
Intervention Type
Drug
Intervention Name(s)
fluticasone propionate, formoterol fumarate
Other Intervention Name(s)
FlutiForm
Intervention Description
Period 1 Treatment Regimen F: Placebo (Two actuations of Placebo HFA pMDI Period 2 Treatment Regimen E: Foradil Aerolizer 12 ug (One inhalation of formoterol DPI 12 ug) Period 3 Treatment Regimen D: Flixotide Evohaler 250 ug (Two actuations of fluticasone HFA MDI 125 ug) Period 4 Treatment Regimen C: Flixotide Evohaler 250 ug + Foradil Aerolizer 12 ug (Two actuations of fluticasone HFA pMDI 125ug/actuation and one inhalation of formoterol DPI 12ug/inhalation)
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Treatment-emergent AEs, clinical laboratory data, 12-lead ECGs and vital signs
Time Frame
10 weeks including pre- and post-study assessments

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SKP
Organizational Affiliation
SkyePharma AG
Official's Role
Study Director
Facility Information:
Facility Name
Investigational site
City
Belfast
Country
Ireland
Facility Name
Investigational site
City
Derbyshire
Country
United Kingdom
Facility Name
Investigational site
City
London
Country
United Kingdom
Facility Name
Investigational site
City
Manchester
Country
United Kingdom
Facility Name
Investigational site
City
Plymouth
Country
United Kingdom
Facility Name
Investigational site
City
Slough
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Single-dose Crossover Study to Compare the Safety and Efficacy of FlutiForm With Fluticasone and Formoterol Concurrently or Alone in Asthma Patients

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