Efficacy and Safety of Indacaterol Acetate Delivered Via the Concept1 Inhalation Device in Children Greater or Equal to 6 and Less Than 12 Years of Age With Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Indacaterol acetate 75 μg; Indacaterol acetate 150 μg
Intervention description: Indacaterol acetate 75 μg o.d. delivered via Concept1 inhaler; Indacaterol acetate 150 μg o.d. delivered via Concept1 inhaler
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 79.0
Sex: All
Minimum age: 6 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: indacaterol acetate, asthma, GINA 2015, pediatrics

Summary:

      This study is designed to explore lung function effects of two doses of indacaterol acetate,
      75 μg and 150 μg, in pediatric asthma patients 6-11 years old, and to compare the systemic
      exposure to indacaterol in plasma with historical data in adults, to identify an appropriate
      dose to Phase III evaluation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female children ≥ 6 years and < 12 years with confirmed diagnosis of asthma
             for at least 1 year prior to study enrollment.

          -  Written informed consent by parent(s)/legal guardian(s) and depending upon their age
             and local requirements a consent or assent for the patient.

          -  Patients receiving daily treatment with a stable low dose Inhaled Corticosteroid (ICS)
             (with or without additional controller), or patients receiving daily treatment with a
             stable mid-dose ICS (monotherapy or together with LTRA) for at least 4 weeks prior to
             Screening, and able to tolerate fluticasone propionate 100 μg b.i.d. inhaler starting
             at Visit 1 (or soon after).

          -  Patients with a pre-bronchodilator FEV1 ≥ 50% and ≤ 90% of the predicted normal value
             for the patient at the start and end of Run-in (Visits 101 and 199).

          -  Patients who demonstrate an increase in FEV1 of 12% within 30 minutes after
             administration of 400 μg salbutamol/360 μg albuterol (or equivalent dose) at Visit
             101. All patients must perform a reversibility test at Visit 101.

        Exclusion Criteria:

          -  Patients taking a mid-dose ICS (per GINA guidelines) in combination with LABA or any
             patient taking high-dose ICS.

          -  Evidence of unstable disease within 4 weeks prior to Screening (Visit 1).

          -  Patients who have had an asthma attack/exacerbation requiring systemic steroids (SCS)
             or hospitalization or emergency room visit within 3 months prior to Visit 1
             (Screening) or more than 3 separate exacerbations in the 12 months preceding Visit 1.

          -  Suspected or documented bacterial or viral infection of the upper or lower respiratory
             tract, sinus or middle ear that is not resolved within 4 weeks of Screening (Visit 1).

          -  Prior intubation for asthma.