Evaluation of Efficacy and Safety for Single Dose of E004 in Children With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multi-center, randomized, double-blinded, placebo-controlled, crossover, single
      dose study in 24 pediatric patients (4-11 years old) with asthma.

      The entire study consists of (i) a Screening Visit and (ii) a Study Period with two (2) Study
      Visits. All study subjects must be properly consented, under adult supervision, and screened
      against the inclusion and exclusion criteria, at the Screening Visit.
    

Detailed description: 
      This is a randomized, double-blinded, placebo-controlled, crossover, single dose study to be
      conducted in pediatric patients (4 - 11 years) with asthma.

      The main features of the study design are:

      The entire study consists of a Screening Visit, and a Study Period consisting of two (2)
      crossover Study Visits separated by a 2 to 14-day interval. All study subjects must be
      properly consented, under adult supervision, and screened against the inclusion and exclusion
      criteria at the Screening Visit and confirmed for enrollment on Visit 1. Efficacy and safety
      evaluations of E004 are conducted at each Study Visit.

      This study employs two (2) double-blinded treatment arms as outlined in Table 2. A
      double-blinded design will be applied to E004 (Arm T) and Placebo-HFA (Arm P) since they are
      identical in all physical attributes and share a comparable formulation.

      The enrolled subjects will be randomized into two sequences (as follows) to participate in
      two (2) crossover Study Visits with a 2 - 14 day interval between visits. Randomization is
      achieved using a ratio of 1:1.

      Use E004 (T) and Placebo (P) in Visits 1 and 2, respectively or use Placebo (P) and E004 (T)
      in Visits 1 and 2, respectively

      Subjects will be trained at the screening visit and each Study Visit for the correct dosing
      and spirometry methods. Under the supervision of dosing monitor, subjects will
      self-administer two (2) inhalations of the randomized study treatment, with a ~1 min interval
      at each Study Visit.

      For the Screening and Study Visits, the subjects will be required to be at the site for a 30
      minute "resting period". This resting period is designed to maintain a stable and consistent
      physical status of the subjects prior to the start of the baseline FEV1 procedures. For the
      Screening Visit, this period will begin upon subject arrival. For the Study Visits, the
      period will begin at the end of the option breakfast (or upon arrival if the breakfast is
      declined).

      For each Study Visit, subjects will need to arrive at the study site early enough to complete
      all necessary baseline evaluations. The study site will provide an optional breakfast but it
      must be eaten at least 30 minutes prior to the pre-dose baseline FEV1 measurements. The
      optional breakfast will be light, and contain no added sugar. If the subjects decline the
      breakfast (i.e. they have already eaten a light breakfast prior to arriving), they are
      required to remain at the site for at least 30 minutes prior to the start of the Baseline
      FEV1 measurements, in order to maintain a stable physical status.

      Baseline vital signs and safety evaluations will be taken prior to the pre-dose baseline FEV1
      measurement. These can be performed during the 30 minute "resting period". Efficacy of the
      treatments at each visit will be evaluated based on spirometric measurements of serial FEV1
      determined at the Pre-dose Baseline, and the seven (7) serial Post-dose FEV1 responses at 5,
      30, 60, 120, 150, 180) and 240 minutes.

      This study will be conducted with a double-blinded technique. This means neither the subject
      nor the site staff will be aware of the identity of the treatment arm since both study
      treatments are in identical looking containers.
    

Intervention name(s): Epinephrine HFA-MDI (E004); Placebo-HFA
Intervention type(s): Drug; Drug
Intervention description(s): Single dose 125 mcg/inhalation, 2 inhalations; Single dose 0 mcg/inhalation, 2 inhalations
Intervention MeSH terms: Epinephrine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma; Safety; Efficacy; Epinephrine; Bronchodilator; Metered dose inhaler