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

August 24, 2010 updated by: SkyePharma AG

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

39

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

  • United States
    • California
      • Anaheim, California, United States, 92801
        • Investigational Site
      • Mission Viejo, California, United States, 92691
        • Investigational Site
    • Colorado
      • 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

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

Ages Eligible for Study

18 years and older (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:

  • 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

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

  • 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
  • Period 2 Treatment Regimen B: FlutiForm 100/10 ug
  • Period 3 Treatment Regimen C: placebo
Drug: fluticasone propionate, formoterol fumarate

● 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:
  • FlutiForm
Placebo Comparator: II
  • 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

● 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:
  • FlutiForm
Other: fluticasone propionate, formoterol fumarate

● 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:
  • FlutiForm
Placebo Comparator: III
  • 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

● 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:
  • FlutiForm
Other: fluticasone propionate, formoterol fumarate

● 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:
  • FlutiForm

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

This is where you will find people and organizations involved with this study.

Sponsor

SkyePharma AG

Collaborators

Abbott

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

September 1, 2008

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

August 4, 2008

First Submitted That Met QC Criteria

August 13, 2008

First Posted (Estimate)

August 14, 2008

Study Record Updates

Last Update Posted (Estimate)

August 27, 2010

Last Update Submitted That Met QC Criteria

August 24, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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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