Efficacy and Safety Comparison of Albuterol Spiromax® and ProAir® Hydrofluoroalkane (HFA) in Pediatric Patients
Condition: Asthma
MeSH terms: Asthma
Intervention: Albuterol Spiromax; ProAir HFA; Placebo
Intervention description: Albuterol Spiromax® Inhalation Aerosol contains 90 mcg albuterol per actuation orally inhaled in a single dose dry powder inhaler (DPI). Participants took doses at either the 90 or 180 mcg levels. If the higher level, two DPIs filled with Albuterol Spiromax® were used.; ProAir® HFA Inhalation Aerosol contains 90 mcg albuterol per actuation orally inhaled in a single dose metered dose inhaler (MDI). Participants took doses at either the 90 or 180 mcg levels. If the higher level, two MDIs filled with ProAir HFA were used.; Single dose MDIs and DPIs containing placebo taken as a single orally-inhaled actuation each.
Intervention MeSH terms: Albuterol; Procaterol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 61.0
Sex: All
Minimum age: 4 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: Albuterol Spiromax; ProAir HFA; albuterol sulfate

Summary:

      This is a multicenter, randomized, double-blind, double-dummy, placebo-controlled,
      single-dose, 5-treatment, 5-period, 5-way crossover study in pediatric patients with
      persistent asthma. The primary purpose of this study is to compare the efficacy and safety of
      Albuterol Spiromax with that of ProAir HFA in pediatric asthma patients at 2 delivered dose
      levels equivalent to 90 mcg and 180 mcg of albuterol base.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Written informed consent/assent signed and dated by the patient and/or
             parent/caregiver/legal guardian (as appropriate) before conducting any study related
             procedure

          2. Male or pre-menarchal female 4-11 years of age, inclusive, as of the screening visit

          3. Has a documented physician diagnosis of persistent asthma of a minimum of 6 months
             duration that has been stable for at least 4 weeks prior to the screening visit. The
             asthma diagnosis must be in accordance with the National Asthma Education and
             Prevention Program Guidelines Expert Panel Report 3 (EPR3)

          4. Has the ability to self-perform spirometry reproducibly per American Thoracic Society
             (ATS) guidelines

          5. Has forced expiratory volume in 1 second (FEV1) 60-90% predicted for age, height, and
             gender at the screening visit based on the pediatric population standards as per
             protocol.

             Notes: (1) Predicted values of 59.50-59.99% may be rounded up to 60% and 90.01-90.49%
             rounded down to 90%. (2) Patients who at the screening visit fail to meet the
             predicted spirometry values for study entry may be allowed a single attempt to
             re-qualify on another day, but they must re-qualify no later than 16 days following
             the first attempt.

          6. Demonstrates reversible bronchoconstriction as verified by a 15% or greater increase
             in baseline FEV1 within 30 minutes following inhalation of 180 mcg of albuterol to 200
             mcg of fluticasone propionate per day or equivalent), leukotriene modifiers (LTM),
             inhaled cromones, or on β2-agonists alone as needed. The Inhaled corticosteroid (ICS),
             LTM, and cromone doses must have been stable for at least 4 weeks prior to the
             screening visit and are expected to be maintained for the duration of the study

          7. Is maintained on low-dose inhaled corticosteroids ([ICS], less than or equal to 200
             mcg of fluticasone propionate per day or equivalent), leukotriene modifiers (LTM),
             inhaled cromones, or on β2-agonists alone as needed. The ICS, LTM, and cromone doses
             must have been stable for at least 4 weeks prior to the screening visit and are
             expected to be maintained for the duration of the study

          8. Can self-perform peak expiratory flow rate (PEF) measurements with a handheld peak
             flow meter

          9. Has the ability to demonstrate acceptable and reproducible inhalation technique with
             the Spiromax and metered dose inhaler (MDI) devices

               -  Other inclusion criteria apply.

        Exclusion Criteria:

          1. Known hypersensitivity to albuterol or any of the excipients in the inhaler
             formulations (lactose, ethanol, etc.)

          2. Participation (receiving study medication) in any investigational drug trial within
             the 30 days preceding the screening visit or planned participation in another
             investigational drug trial at any time during this trial

          3. History of severe milk protein allergy

          4. History of a respiratory infection or disorder (including, but not limited to
             bronchitis, pneumonia, acute or chronic sinusitis, otitis media, influenza, etc.) that
             has not resolved within 4 weeks preceding the screening visit

          5. Any asthma exacerbation requiring oral corticosteroids within 3 months of the
             screening visit. A patient must not have had any hospitalization for asthma within 6
             months prior to the screening visit.

          6. History of life-threatening asthma that is defined for this protocol as an asthma
             episode that required intubation and/or was associated with hypercapnea, respiratory
             arrest, or hypoxic seizures

          7. Use of any prohibited concomitant medications within the washout period prescribed per
             protocol prior to the screening visit.

          8. Use of any medication for asthma or allergic rhinitis that is prohibited per the
             protocol

          9. The dosage of any required intranasal corticosteroid and/or cromone has not been
             stable for at least 2 weeks prior to the screening visit.

         10. Treated with oral or injectable corticosteroids within the 6 weeks before the
             screening visit.

         11. Initiation of immunotherapy during the study period or dose escalation during the
             study period. Patients being treated with immunotherapy prior to the screening visit
             must be using a stable (maintenance) dose (90 days or more) to be considered for
             inclusion.