PROAIR HFA 90 MCG INHALER TRIAL

Use of any medication for asthma or allergic rhinitis that is prohibited per the protocol.

Use of any prohibited concomitant medications within the washout period prescribed per protocol prior to the screening visit.

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.

A patient must not have had any hospitalization for asthma within 6 months prior to the screening visit.

Any asthma exacerbation requiring oral corticosteroids within 3 months of the screening visit.

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.

PROAIR HFA 90 MCG INHALER TRIAL

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.

Known hypersensitivity to albuterol or any of the excipients in the inhaler formulations (lactose, ethanol, etc.).

Has the ability to demonstrate acceptable and reproducible inhalation technique with the Spiromax and metered dose inhaler (MDI) devices

Can self-perform peak expiratory flow rate (PEF) measurements with a handheld peak flow meter.

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 Is maintained on low-dose inhaled corticosteroids (, 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 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 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.(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. 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. Has the ability to self-perform spirometry reproducibly per American Thoracic Society (ATS) guidelines.The asthma diagnosis must be in accordance with the National Asthma Education and Prevention Program Guidelines Expert Panel Report 3 (EPR3)

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.Male or pre-menarchal female 4-11 years of age, inclusive, as of the screening visit.Written informed consent/assent signed and dated by the patient and/or parent/caregiver/legal guardian (as appropriate) before conducting any study related procedure.

Why Should I Register and Submit Results?.

Proair hfa 90 mcg inhaler