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

This study has been completed.
Sponsor:
Collaborator:
Abbott
Information provided by:
SkyePharma AG
ClinicalTrials.gov Identifier:
NCT00657774
First received: April 8, 2008
Last updated: November 28, 2008
Last verified: November 2008
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: FlutiForm 250/10 ug
Drug: FlutiForm 100/10 ug
Drug: Oral Prednisone 10mg
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel Group, 6-Week Study to Evaluate the Effect of Multiple Doses of FlutiForm™ 250/10 Microgram HFA pMDI Twice Daily, FlutiForm™ 100/10 Microgram HFA pMDI Twice Daily, Prednisone and Placebo on the Hypothalmic-Pituitary-Adrenal Axis in Adult Subjects With Mild to Moderate Asthma.

Resource links provided by NLM:


Further study details as provided by SkyePharma AG:

Primary Outcome Measures:
  • 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 [ Time Frame: Baseline and Study days 42-43 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. [ Time Frame: From Baseline up to 2 weeks after last dosing ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 160
Study Start Date: April 2008
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
FlutiForm 250/10 ug
Drug: FlutiForm 250/10 ug
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.
Experimental: 2
FlutiForm 100/10 ug
Drug: FlutiForm 100/10 ug
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.
Active Comparator: 3
Oral Prednisone 10 mg
Drug: Oral Prednisone 10mg
2 x 5 mg oral prednisone tablets, over encapsulated, once a day for one week.
Placebo Comparator: 4
Placebo inhaler and/or placebo tablets
Drug: Placebo
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.

Detailed Description:

This is a Phase-1 randomized, double-blind, placebo- and active-controlled, parallel group 6 week study to evaluate the effect on the HPA axis of treatment with SKP FlutiForm 250/10 mg HFA pMDI twice daily administered over 6 weeks, FlutiForm 100/10 mg HFA pMDI twice daily administered over 6 weeks and 10 mg prednisone administered over 7 days compared to placebo. All subjects will undergo a Screening Visit to determine eligibility for the study and training on pMDI use. Eligible subjects will meet all of the following criteria: at least 6 month history of asthma, demonstrate an FEV1 of at least ≥ 60 % of predicted normal values at both Screening and Baseline visits, and stable asthma without the use of inhaled steroids for the past month or oral or parenteral corticosteroids for the past three months. All subjects will be admitted to the study site on the morning of Study Day -1 to begin a 24-hour urine collection and undergo Baseline trough PK sampling. On the morning of Study Day 1, subjects will be randomized to one of four treatment groups: SKP FlutiForm 250/10 mg twice daily + placebo capsule for six weeks, SKP FlutiForm 100/10 mg twice daily + placebo capsule for six weeks, Placebo inhaler + placebo capsule for six weeks or Placebo inhaler for six weeks + placebo capsule for 5 weeks followed by one week of 10 mg prednisone QD. After the first dose, subjects will be discharged from the study site to continue dosing at home for 6 weeks. Subjects will be required to record their compliance with their twice daily inhaler dosing and once daily oral medication dosing in a diary. Subjects will also record their predose morning and evening Peak Expiratory Flow Rate (PEFR) in a diary. Clinic visits will occur at Study Days 7, 14 and 35 during which safety assessments (AEs and vital signs) will be made, trough PK samples will be obtained and pMDI training will be continued. Also, subjects will return to the study site in the morning on Study Days 40 to 41 for observed dosing of prednisone or placebo. Subjects will be readmitted to the study site in the morning on Study Day 42 for trough PK sampling, observed dosing of prednisone or placebo and to begin a 24-hour urine collection. A safety follow-up phone call will occur 7 days later.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • Additional inclusion and exclusion criteria will evaluated by the investigator.
  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: NCT00657774

Locations
United States, Arizona
Investigational site
Phoenix, Arizona, United States, 85006
United States, California
Investigational site
Anaheim, California, United States, 92801
Investigational site
Long Beach, California, United States, 90806
Investigational site
San Diego, California, United States, 92120
United States, Colorado
Investigational site
Centennial, Colorado, United States, 80112
Investigational site
Colorado Springs, Colorado, United States, 80907
Investigational site
Denver, Colorado, United States, 80206
Investigational site
Lakewood, Colorado, United States, 80401
United States, Florida
Investigational site
Deland, Florida, United States, 32720
United States, Maryland
Investigational Site
Pasadena, Maryland, United States, 21122
United States, Massachusetts
Investigational site
North Dartmouth, Massachusetts, United States, 02747
United States, Nebraska
Investigational site
Omaha, Nebraska, United States, 68154
United States, New Jersey
Investigational site
Skillman, New Jersey, United States, 08558
United States, Oregon
Investigational Site
Lake Oswego, Oregon, United States, 97035
Investigational site
Portland, Oregon, United States, 97213
United States, South Carolina
Investigational site
Spartanburg, South Carolina, United States, 29303
United States, Texas
Investigational site
El Paso, Texas, United States, 79902
Investigational site
New Braunfels, Texas, United States, 78130
Investigational site
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
SkyePharma AG
Abbott
  More Information

No publications provided

Responsible Party: SKYEPHARMA AG
ClinicalTrials.gov Identifier: NCT00657774     History of Changes
Other Study ID Numbers: SKY2028-1-003
Study First Received: April 8, 2008
Last Updated: November 28, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by SkyePharma AG:
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
Prednisone
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 31, 2014