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

This study has been completed.
Sponsor:
Collaborator:
Abbott
Information provided by:
SkyePharma AG
ClinicalTrials.gov Identifier:
NCT00734292
First received: August 4, 2008
Last updated: August 24, 2010
Last verified: August 2010
  Purpose

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


Condition Intervention Phase
Mild to Moderate Asthma
Drug: fluticasone propionate, formoterol fumarate
Other: fluticasone propionate, formoterol fumarate
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Official 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

Resource links provided by NLM:


Further study details as provided by SkyePharma AG:

Primary Outcome Measures:
  • Change from baseline FEV1 to post study drug dosing FEV1 [ Time Frame: 3 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline FEV1 to post study drug dosing FEV1 [ Time Frame: 8, 15, 30, and 60 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 39
Study Start Date: September 2008
Study Completion Date: October 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 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 Name: FlutiForm

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00734292

Locations
United States, California
Investigational Site
Anaheim, California, United States, 92801
Investigational Site
Mission Viejo, California, United States, 92691
United States, Colorado
Investigational Site
Denver, Colorado, United States, 80230
United States, Florida
Investigational Site
Valrico, Florida, United States, 33594
United States, Oregon
Investigational Site
Medford, Oregon, United States, 97504
Investigational Site
Portland, Oregon, United States, 97213
United States, Virginia
Investigational Site
Richmond, Virginia, United States, 23229
United States, Wisconsin
Investigational Site
West Allis, Wisconsin, United States, 53227
Sponsors and Collaborators
SkyePharma AG
Abbott
  More Information

No publications provided

Responsible Party: SkyePharma AG
ClinicalTrials.gov Identifier: NCT00734292     History of Changes
Other Study ID Numbers: SKY2028-2-002
Study First Received: August 4, 2008
Last Updated: August 24, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by SkyePharma AG:
Asthma
Asthma Mild to Moderate

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Formoterol
Fluticasone
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents

ClinicalTrials.gov processed this record on August 28, 2014