To Compare the Pharmacokinetics of Budesonide Delivered by BDA MDI to Budesonide Delivered by Pulmicort Respules in Children With Asthma Aged 4 to 8 Years.
Condition: Asthma
MeSH terms: Asthma
Intervention: BDA MDI (PT027) 160/180 μg; Pulmicort Respules 0.5 MG/ML Inhalation Suspension
Intervention description: Combination Product: Budesonide/albuterol sulfate metered-dose inhaler 80/90 μg per puff. Two puffs to administer 160/180 μg dose.; Budesonide 0.5 mg/ml. Each 2 ml Respule contains 1 mg budesonide.
Intervention MeSH terms: Budesonide
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 4 Years
Maximum age: 8 Years
Healthy volunteers: No

Summary:

      To compare the pharmacokinetics of budesonide delivered by BDA MDI to budesonide delivered by
      Pulmicort Respules in children with Asthma aged 4 to 8 years.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Provision of informed consent prior to any study specific procedures. Children should
             provide assent to join the study, as applicable. The child's parent(s) or legally
             authorized representative (LAR) must sign the informed consent form (ICF). The LAR
             must be aged ≥18 years old.

          2. Male or female aged between 4 and 8 years inclusive (not having reached his/her 9th
             birthday by the time of screening).

          3. Weigh at least 14 kg or higher.

          4. Clinician diagnosed asthma of at least 3 months.

          5. Stable on treatment with albuterol PRN and/or ICS and/or leukotriene receptor
             antagonists (LTRAs) for 2 weeks prior to screening; children taking budesonide in any
             form at Visit 1 will be switched to another corticosteroid with a washout of
             budesonide of 3 to 7 days.

          6. Demonstrate ability to correctly use the nebulizer and metered-dose inhaler (MDI)
             device without a spacer.

          7. Willingness and ability of the child and parent(s)/LAR to comply with the demands of
             the study as described in the informed consent/assent.

        Exclusion Criteria:

          1. Inability to change from any budesonide therapy to another suitable corticosteroid.

          2. History of life-threatening asthma defined as any asthma episode associated with loss
             of consciousness, intubation or admission to an intensive care unit.

          3. Unstable asthma as judged by the Investigator (eg, any change in asthma therapy within
             2 weeks prior to screening or use of more than 2 occasions of rescue medication
             (albuterol) per day within 1 week prior to screening (potential for rescreen).

          4. Children receiving regular maintenance treatment with prohibited anti-inflammatory or
             long-acting bronchodilator asthma medication (inhaled, nebulized, oral, or systemic)
             within 1 month prior to screening.

          5. More than 1 short course of oral/rectal/systemic corticosteroids within 6 months
             preceding screening (Visit 1), or any oral/rectal/systemic corticosteroids within 30
             days prior to screening.

          6. Evidence of active concomitant pulmonary disease other than asthma (children with
             stable allergic rhinitis will be permitted, as long as, there are no changes in the
             treatment and the medications do not interfere with the analytical assay methods).

          7. Upper respiratory infection involving antibiotic treatment not resolved within 14 days
             prior to Visit 1.

          8. Children with a known or suspected hypersensitivity to albuterol/salbutamol,
             budesonide or any of the excipients used in the IMPs.