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Completed

NCT Number: NCT00734292

Single-dose Crossover Study to Evaluate the Early Bronchodilating Effect of FlutiForm HFA pMDI 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.

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Key information

Conditions

Mild to Moderate Asthma Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Investigational Site, Anaheim, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fluticasone propionate, formoterol fumarate

Drug

● 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

fluticasone propionate, formoterol fumarate

Other

● 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

Primary outcomes

  1. Change from baseline FEV1 to post study drug dosing FEV1

    Time frame: 3 minutes

Secondary outcomes

  1. Change from baseline FEV1 to post study drug dosing FEV1

    Time frame: 8, 15, 30, and 60 minutes

Sponsors and collaborators

Lead sponsor

SkyePharma AG

Industry

Collaborators

  • Abbott

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Aug 14, 2008
Registry last updated
Aug 27, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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