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New Combination Inhaler (FlutiForm HFA MDI 100/10 µg and 250/10 µg) Versus Fluticasone and Formoterol Administered Alone, and Placebo in Patients With Moderate to Severe Asthma

S

SkyePharma

Status and phase

Completed
Phase 3

Conditions

Asthma

Treatments

Drug: Placebo
Drug: Fluticasone propionate 250
Drug: Formoterol fumarate 10
Drug: Fluticasone propionate/Formoterol fumarate 100/10
Drug: Fluticasone propionate/Formoterol fumarate 250/10

Study type

Interventional

Funder types

Industry

Identifiers

NCT00393952
SKY2028-3-004

Details and patient eligibility

About

The purpose of this study is to compare the efficacy and safety of the fixed combination asthma drug FlutiForm with its two components administered alone, fluticasone propionate and formoterol fumarate, and with placebo in adult and adolescent patients with moderate to severe asthma.

Enrollment

557 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Ages eligible for study: 12 years and above; genders eligible for study: both; prior steroid use: steroid-requiring

Inclusion Criteria:

  • History of asthma for at least 12 months.
  • Documented use of inhaled corticosteroid for at least 4 weeks prior to Screening Visit Demonstrate FEV-1 of 40-80% of predicted normal values at Screening and Baseline Visit.
  • Documented reversibility of 15% within 12 months of Screening visit or at Screening Visit (15% increase from pre-FEV-1 levels following albuterol inhalation or nebulized albuterol administration).
  • Symptoms of Asthma during Run-in.
  • Females of childbearing potential must have a negative urine pregnancy test at Screening and Baseline Visits. Females are eligible only if they are not pregnant or lactating, and are either sterile or using acceptable methods of contraception
  • Must otherwise be healthy.
  • Provide written informed consent. Wishes of minors must be respected.

Exclusion Criteria:

  • Life-threatening asthma within past year or during Run-In Period.
  • History of systemic corticosteroid medication within 3 months before Screening Visit.
  • History of omalizumab use within past 6 months.
  • History of leukotriene receptor antagonist use, e.g. montelukast, within past week.
  • Current evidence or history of any clinically significant disease or abnormality including uncontrolled hypertension, uncontrolled coronary artery disease, congestive heart failure, myocardial infarction, or cardiac dysrhythmia.
  • Upper or lower respiratory infection within 4 weeks prior to Screening visit or during Run-In Period
  • Significant, non-reversible, pulmonary disease (e.g., chronic obstructive pulmonary disease [COPD], cystic fibrosis, bronchiectasis).
  • Known Human Immunodeficiency Virus (HIV)-positive status.
  • Smoking history equivalent to "10 pack years".
  • Current smoking history within 12 months prior to Screening Visit.
  • Current evidence or history of alcohol and/or substance abuse within 12 months prior to Screening visit.
  • Patients who are confined in institution.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

557 participants in 5 patient groups, including a placebo group

1
Experimental group
Description:
FlutiForm 250/10
Treatment:
Drug: Fluticasone propionate/Formoterol fumarate 250/10
2
Active Comparator group
Description:
FlutiForm 100/10
Treatment:
Drug: Fluticasone propionate/Formoterol fumarate 100/10
3
Active Comparator group
Description:
Fluticasone 250
Treatment:
Drug: Fluticasone propionate 250
4
Active Comparator group
Description:
Formoterol 10
Treatment:
Drug: Formoterol fumarate 10
5
Placebo Comparator group
Description:
Placebo
Treatment:
Drug: Placebo

Trial contacts and locations

63

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Data sourced from clinicaltrials.gov

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