A Non-inferiority Study to Evaluate Efficacy, Safety and Tolerability of NEUMOTEROL® 400 and SYMBICORT® Forte in Adults With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      This Phase IV study is an a multi-centre, randomised open label, two way cross-over design to
      evaluate the efficacy, safety, and tolerability of NEUMOTEROL 400 in subjects with asthma.
      The study will be used to demonstrate the non-inferiority of Budesonide/Formoterol Fumarate
      combination (BFF) 400/12 micrograms (mcg) single capsule inhaler (NEUMOTEROL 400) compared
      with BFF 320/9 mcg SYMBICORT Forte TURBUHALER® inhaler.

      The population for this study will be adult subjects (>=18 and <=80 years) with a diagnosis
      of asthma who have a pre-bronchodilator forced expiratory volume in one second (FEV1) of 40%
      to 85% of the predicted normal value, and are receiving a stable dose of inhaled
      corticosteroid inhaled corticosteroid (ICS) with or without long-acting beta-adrenergic
      agonist (LABA) prior to screening.

      The study will consist of six phases: Prescreening, Screening/Run-in (4 weeks), Treatment
      Period 1 (4 weeks), Washout (minimum 4 weeks), Treatment Period 2 (4 weeks) and Follow-up (1
      week). The total duration of the study for each subject will be at least 17 weeks. There will
      be up to 6 study visits and a follow-up telephone call.

      Pre-screening Visit will allow subjects who had recent asthma medication changes to be
      stabilized prior to Screening. During the run-in and wash-out periods, all the subjects will
      receive budesonide dry powder inhaler (DPI) 400 mcg twice daily (BID) (NEUMOTEX™ 400) and
      salbutamol 100mcg pressurized metered dose inhaler (pMDI) on demand, as rescue medication.
      The dose of NEUMOTEROL 400 (400/12 mcg) and SYMBICORT Forte (320/9 mcg) will be one
      inhalation BID, and each treatment will be given to all subjects for 4 weeks (with a 4-week
      Washout Period between treatments).

      The study will include 300 subjects for screening so that at least 210 will be randomised and
      a minimum of 168 subjects complete the study/are evaluable. Half the subjects will be on
      Regimen A in Treatment Period 1and will then be crossed over to Regimen B in Treatment Period
      2, and vice versa. Regimen A: BFF (400/12 mcg) by single capsule inhaler. Regimen B: BFF
      (320/9 mcg) TURBUHALER inhaler. The treatment periods will be separated by a washout Period
      of 4 weeks.

      NEUMOTEROL and NEUMOTEX are trademarks of the GSK group of companies SYMBICORT and TURBUHALER
      are trademarks of AstraZeneca
    


Intervention name(s): NEUMOTEROL 400 (BFF 400/12 mcg) single capsule inhaler; SYMBICORT forte (BFF 320/9mcg) TURBUHALER inhaler; NEUMOTEX 400 (Budesonide 400 mcg); Salbutamol 100 mcg pMDI
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Micronized 400 mcg budesonide+ 12 mcg formoterol fumarate along with micronized and crystalline lactose monohydrate (excipient), per capsule dispensed by single capsule inhaler, twice daily (administered once in the morning and once in the evening approximately 12 hours later).; Unit dose containing 320 mcg budesonide and 9 mcg formoterol fumarate (as dihidrate) along with lactose monohydrate as excipient. Administered as inhalation by TURBUHALER inhaler, twice daily (once in the morning and once in the evening approximately 12 hours later); Budesonide 400mcg will be administered to all the subjects twice daily, during the Run-in and Washout Periods; Salbutamol 100mcg will be administered as pMDI on demand, as rescue medication, throughout the entire study period until Visit 5
Intervention MeSH terms: Budesonide; Albuterol; Budesonide, Formoterol Fumarate Drug Combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: tolerability; NEUMOTEROL; efficacy; budesonide/formoterol fumarate 400/12 mcg; safety; Asthma; pharmacodynamics