Evaluation of Two Doses of QVAR by Breath Operated and Metered Dose Inhalers in Asthmatic Children

Exclusion Criteria

• •Patients who have used inhaled corticosteroids within 30 days prior to the screening visit.
• •Allergy or sensitivity to beclomethasone dipropionate (BDP) or to other components of the formulations used in the CTM
• •Patients demonstrating an increase or decrease in FEV1 \>20% between the screening and baseline visit.
• •Patients who are unable to use a metered dose inhaler (MDI) without a spacer device.
• •Patients requiring the use of \>12 puffs per day of albuterol for any 3 consecutive days between the screening and baseline visits.
• •Patients with evidence of growth retardation
• •Patients who have been treated with methotrexate, cyclosporin, gold or other cytotoxic agents for the control of asthma or for a concurrent condition within the last 3 months.
• •Patients who are receiving escalating doses of immunotherapy, oral immunotherapy or short course (rush) immunotherapy for rhinitis.
• •Patients with evidence (on physical exam) of oropharyngeal candidiasis.
• •Exposure to investigational drugs within 30 days prior to the screening visit
• •Require continuous treatment with beta blockers MAO inhibitors, tricyclic antidepressants, anticholinergics, inhaled nedocromil or cromolyn, or nebulized therapy (excluding sponsor provided albuterol MDI)
• •Inability to tolerate or unwillingness to comply with required washout periods for all applicable medications
• •Treatment at any time for life-threatening asthmatic episodes (e.g., episodes requiring intubation and/or associated with the development of hypercapnia, hypoxia and seizures, etc.)
• •Patients that have received any of the following treatments or met any of the following conditions within six weeks prior to the screening visit:
• •* Oral or injectable corticosteroids
• •* an upper respiratory tract infection and/or sinusitis associated with exacerbation of asthmatic symptoms
• •* emergency room treatment or hospitalization for asthmatic symptoms.
• •History and/or presence of any non-asthmatic acute or chronic lung disease, including but not limited to bronchitis (within the previous 6 months), emphysema, active tuberculosis, bronchiectasis or cystic fibrosis.
• •Presence of any clinically-significant cardiovascular disease (including cardiac arrhythmias and uncontrolled hypertension), clinically-significant hepatic, renal, or endocrine dysfunction, stroke, uncontrolled diabetes, hyperthyroidism, convulsive disorders, neoplastic disease other than basal cell carcinoma, and significant psychiatric disease.
• •History of glaucoma or cataracts
• •Presence of systemic fungal, bacterial, viral or parasitic infections and/or ocular herpes simplex
• •Unlikely to be compliant, take study medication as directed, complete the diary cards, or attend scheduled clinic visits as required.