A Chronic-Dose Safety and Efficacy Study of Albuterol Multi-Dose Dry Powder Inhaler in Pediatric Asthmatics
Condition: Asthma
MeSH terms: Asthma
Intervention: Albuterol MDPI; Placebo; ProAir HFA inhaler
Intervention description: 90 mcg/actuation of the multidose dry powder inhaler (MDPI).; Matching Placebo delivered via a multidose dry powder inhaler (MDPI).; Rescue medication, ProAir hydrofluoroalkane (HFA) inhaler, was dispensed at the run-in visit for the relief of asthma symptoms to be administered as needed.
Intervention MeSH terms: Albuterol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 186.0
Sex: All
Minimum age: 4 Years
Maximum age: 11 Years
Healthy volunteers: No

Summary:

      The study is to evaluate the chronic-dose efficacy and the safety of Albuterol MDPI compared
      to placebo in pediatric participants with asthma.
    

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 premenarchal female 4-11 years of age, inclusive, as of the screening visit
             (SV)

          3. Has a documented physician diagnosis of asthma per the EPR-3 Guidelines of a minimum
             of 6 months duration that has been stable for at least 4 weeks prior to the SV

          4. Has the ability to perform spirometry reproducibly consistent with ATS guidelines and
             protocol-specific guidelines

          5. Has FEV1 50-95% predicted for age, height and gender at the SV following a minimum
             6-hour period without β2-agonist use. (Note: Predicted values of 49.50-49.99% may be
             rounded up to 50% and values of 95.01-95.49% may be rounded down to 95%.)

          6. Demonstrated reversible bronchoconstriction as verified by a 15% or greater increase
             in baseline FEV1 within 30 minutes following inhalation of 180 mcg of albuterol.
             (Note: Reversibility values of 14.50-14.99% may be rounded up to 15%.)

          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), or
             inhaled cromones, and/or on short-acting β2-agonists (SABA); as needed SABA alone is
             acceptable. The ICS, LTM, and cromone doses must have been stable for at least 4 weeks
             prior to the SV and should 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. Can tolerate the withdrawal of applicable medications for qualification at screening

         10. Otherwise in general good health, defined as free of any concomitant conditions or
             treatment that could interfere with study conduct, influence the interpretation of
             study observations/results, or put the patient at increased risk during the trial, and
             with a clinically acceptable 6-month medical history, physical examination, 12-lead
             electrocardiogram (ECG), and vital signs

         11. Parents consenting are capable of understanding the requirements, risks and benefits
             of study participation, and, as judged by the investigator, capable of giving informed
             consent and being compliant with all study requirements (eg, visits, record-keeping)

         12. The patient is able to correctly use the MDPI device, either alone or with assistance
             by a parent/guardian.

        Exclusion Criteria

          1. Known hypersensitivity to albuterol or any of the excipients in the inhaler
             formulations (eg, lactose, ethanol)

          2. Participation (receiving study medication) in any investigational drug trial within
             the 30 days preceding the SV 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) that has
             not resolved within 4 weeks preceding the SV

          5. Any asthma exacerbation requiring oral corticosteroids within 3 months of the SV. A
             patient must not have had any hospitalization for asthma within 6 months prior to the
             SV.

          6. Initiation of immunotherapy during the study period or dose escalation during the
             study period. Patients being treated with immunotherapy prior to the SV must be using
             a stable (maintenance) dose (90 days or more) to be considered for inclusion.

          7. 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

          8. Use of any prohibited concomitant medications within the washout prescribed per
             protocol prior to study visits

          9. Use of any medication for asthma or allergic rhinitis that is prohibited per the
             protocol as described in the protocol

         10. The dosage of any required LTM, ICS, or inhaled cromones, has not been stable for at
             least 4 weeks. Intranasal corticosteroid and/or cromones have not been stable for at
             least two weeks prior to the SV. Allowed corticosteroid, LTM, and cromone asthma and
             allergy medications should be continued at the same doses during the conduct of the
             study.

         11. Presence of any non-asthmatic acute or chronic condition, including but not limited to
             bronchitis, emphysema, active tuberculosis, bronchiectasis, cystic fibrosis,
             clinically significant cardiovascular disease (including but not limited to cardiac
             arrhythmias and uncontrolled hypertension), clinically significant hepatic, renal, or
             endocrine dysfunction, stroke, uncontrolled diabetes mellitus, hyperthyroidism,
             convulsive disorder, and malignancy other than basal cell carcinoma. Significant is
             defined as any condition that, in the opinion of the investigator, would put the
             safety of the patient at risk through participation, or which could affect the safety
             or efficacy analyses

         12. Any other medical or psychological condition that in the investigator's opinion should
             preclude study enrollment

         13. Previous participation (received MDPI study medication) in an Albuterol MDPI study

         14. Study participation by clinical investigator site employees and/or their immediate
             relatives

         15. Study participation by related or non-related individuals living in the same
             household, ie, only one subject per household may participate in the study at the same
             time.

         16. Require continuous treatment with β-blockers, MAO inhibitors, tricyclic
             antidepressants, anticholinergics, and/or systemic corticosteroids

         17. Treated with oral or injectable corticosteroids within the 6 weeks prior to SV

         18. Hospitalization for acute asthma exacerbation >2 times in 12 months prior to screening
             and/or received emergency room treatment other than nebulized albuterol or been
             hospitalized for asthma exacerbations within 6 months prior to SV