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
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

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.
    

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.
    

Intervention name(s): FlutiForm 250/10 ug; FlutiForm 100/10 ug; Oral Prednisone 10mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 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.; 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 x 5 mg oral prednisone tablets, over encapsulated, once a day for one week.; 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.
Intervention MeSH terms: Prednisone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Asthma; Mild to Moderate