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

Safety and Efficacy Evaluation of Two Doses of HFA-Propelled Beclomethasone Dipropionate (QVAR) Versus Placebo by Breath Operated and Metered Dose Inhalers in Mild to Moderate Asthmatic Children

The primary objective of this study is to compare the QVAR-Easi-Breathe 100 mcg/day and QVAR-Easi-Breathe 200 mcg/day with placebo relative to changes in forced expiratory volume in 1 second (FEV1) results following 12 weeks of treatment. Secondary objectives such as daily asthma symptoms scores (per week), morning peak expiratory flow (PEF) values, nocturnal awakening and utilization of rescue medication per day also will be evaluated. In addition, an exploratory evaluation will assess the comparability of the two devices (i.e., QVAR-Easi-Breathe versus QVAR-MDI) at the same dose levels.

Inclusion Criteria:

• Male or female children aged 5 through 11 years at the screening visit
• Documented clinical evidence of asthma (FEV1 = 65-90%)
• Ability to perform acceptable and reproducible spirometry per ATS guidelines
• Ability to perform PEF determinations
• Reversible bronchoconstriction as verified by >12% increase in FEV1
• Otherwise healthy children with clinically-acceptable medical history, physical examination, vital signs and clinical laboratory parameters within the acceptable ranges for asthma patients
• The parent or guardian must be willing to give written informed consent as well as the patient assent and be able to adhere to the dose and visit schedule.

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.