A Phase I Study in Asthma Patients Evaluating the Effect of Doses of FlutiForm™ on the Amount, if Any, of Cortisol Produced by the Adrenal Glands

NCT00657774 | Completed Phase 1

• 1 other identifier: SKY2028-1-003
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 19

Brief Summary

The medications being used in this study are individually approved by the Food and Drug Administration (FDA). The medication under investigation is a combination of the two medications in one inhaler. The purpose of the study is to determine how the medication affects the amount, if any, of cortisol produced by the adrenal glands.

Conditions

Asthma

Keywords

Asthma; Mild to Moderate

Outcome Measures

Primary Outcomes (1)

• Investigate effect of SKP FlutiForm 250/10 ug HFA pMDI BID for 6 weeks, FlutiForm 100/10 ug HFA pMDI BID, 10 mg prednisone for 7 days, compared to Placebo on the hypothalamic-pituitary-adrenal (HPA) axis using measurement of 24-hours UFC

  Baseline and Study days 42-43

Secondary Outcomes (1)

• To assess the safety profile of SKP FlutiForm HFA pMDI using incidence of adverse events (AEs) and changes in electrocardiograms (ECGs), vital signs and clinical laboratory tests.

  From Baseline up to 2 weeks after last dosing

Study Arms (4)

1

EXPERIMENTAL

FlutiForm 250/10 ug

Drug: FlutiForm 250/10 ug

2

EXPERIMENTAL

FlutiForm 100/10 ug

Drug: FlutiForm 100/10 ug

3

ACTIVE COMPARATOR

Oral Prednisone 10 mg

Drug: Oral Prednisone 10mg

4

PLACEBO COMPARATOR

Placebo inhaler and/or placebo tablets

Drug: Placebo

Interventions

FlutiForm 250/10 ug DRUG

SKP FlutiForm 250/10ug is a HFA pMDI that delivers 125ug of Fluticasone propionate per actuation and 5ug of Formoterol fumarate per actuation. Patients will take 2 actuations BID for 6 weeks.

1

FlutiForm 100/10 ug DRUG

SKP FlutiForm 100/10ug is a HFA pMDI that delivers 50ug of Fluticasone propionate per actuation and 5ug of Formoterol fumarate per actuation. Patients will take 2 actuations BID for 6 weeks.

2

Oral Prednisone 10mg DRUG

2 x 5 mg oral prednisone tablets, over encapsulated, once a day for one week.

3

Placebo DRUG

2 x 5 mg placebo tablets, over encapsulated, once a day for six weeks. SKP FlutiForm placebo HFA pMDI. Two actuations BID for six weeks.

4

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65 at the Screening Visit;
• History of asthma for at least 6 months prior to Screening Visit
• Well controlled asthma with rescue short acting beta agonist (albuterol) and or stable doses of other medications for at least 4 weeks prior to Screening Visit
• Female subjects that are not pregnant or lactating
• Otherwise healthy as determined by the Investigator.

You may not qualify if:

• Life-threatening asthma within the past year or visit to emergency room for asthma in the past 3 months prior to the Screening Visit;
• Significant,nonreversible pulmonary disease (e.g. chronic obstructive pulmonary disease, cystic fibrosis or bronchiectasis)
• Use of any steroid medications, topical or inhaled steroids within 4 weeks or systemic (oral or injectable) steroids within 3 months of dosing
• An upper or lower respiratory tract infection within the last 4 weeks pior to Screening Visit or acute illness or infection within 6 weeks prior to dosing
• Any significant disease or major disorder that may jeopardize subject safety
• History of tabacco use within 6 months prior to dosing and/or smoking history \> 10 pack-years
• Female subjects on hormone replacement therapy or using birth control involving hormones in the past 6 months

Sponsors & Collaborators

• SkyePharma AG: lead
• Abbott: collaborator

Study Sites (19)

Investigational site

Phoenix, Arizona, 85006, United States

Location

Investigational site

Anaheim, California, 92801, United States

Location

Investigational site

Long Beach, California, 90806, United States

Location

Investigational site

San Diego, California, 92120, United States

Location

Investigational site

Centennial, Colorado, 80112, United States

Location

Investigational site

Colorado Springs, Colorado, 80907, United States

Location

Investigational site

Denver, Colorado, 80206, United States

Location

Investigational site

Lakewood, Colorado, 80401, United States

Location

Investigational site

DeLand, Florida, 32720, United States

Location

Investigational Site

Pasadena, Maryland, 21122, United States

Location

Investigational site

North Dartmouth, Massachusetts, 02747, United States

Location

Investigational site

Omaha, Nebraska, 68154, United States

Location

Investigational site

Skillman, New Jersey, 08558, United States

Location

Investigational Site

Lake Oswego, Oregon, 97035, United States

Location

Investigational site

Portland, Oregon, 97213, United States

Location

Investigational site

Spartanburg, South Carolina, 29303, United States

Location

Investigational site

El Paso, Texas, 79902, United States

Location

Investigational site

New Braunfels, Texas, 78130, United States

Location

Investigational site

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

fluticasone-formoterol; Prednisone

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 8, 2008
• First Posted: April 14, 2008
• Study Start: April 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: December 1, 2008

Record last verified: 2008-11

Locations

US (19)