Inspiratory flow rates and volumes with the Aerolizer dry powder inhaler in asthmatic children and adults.

OBJECTIVE: To assess the peak inspiratory flow rate (PIFR) and forced inspiratory vital capacity (FIVC) through the formoterol (Foradil*) Aerolizer* in patients with mild, moderate and severe asthma. RESEARCH DESIGN AND METHODS: PIFR and FIVC were assessed in 33 adults and 32 children using a spirometer alone (baseline), a spirometer with an adaptor, and a spirometer with an adaptor and the Aerolizer inhaler (placebo loaded). RESULTS: Of adult patients using the Aerolizer inhaler, 73% had PIFR values of >100 l/min and 91% had values of >60 l/min. PIFR in adults was reduced from a mean baseline of 283 l/min to 118 l/min through the loaded Aerolizer inhaler. Similarly, 75% of children using the Aerolizer inhaler had PIFR values >80 l/min and 91% had values of > 60 l/min. The mean PIFR in children was reduced from a baseline of 154 l/min to 100 l/min through the loaded Aerolizer inhaler. Only small mean decreases from baseline were observed in FIVC through the loaded Aerolizer inhaler: 8.4% in adults and 3.8% in children. FIVC values of > 2.0 litre were achieved in 82% of adults, and 81% of children achieved FIVC values of >1.5 litre. CONCLUSIONS: This study, albeit in a relatively small patient population, suggests that most children and adults with asthma can generate PIFRs of > 60 l/min and FIVCs of > 1.5 litre through the Aerolizer inhaler regardless of their disease severity. Such findings compare extremely favourably with other dry powder inhalers.

Efficacy and safety of budesonide inhalation powder (Pulmicort Turbuhaler) during 52 weeks of treatment in adults and children with persistent asthma.

BACKGROUND: Inhaled corticosteroids are the agents of choice for treating persistent asthma. OBJECTIVE: To evaluate the long-term efficacy and safety of budesonide inhalation powder (Pulmicort Turbuhaler) in patients with mild to severe persistent asthma. METHODS: Patients (n=1133) received open-label budesonide (dose range, 100-800 microg b.i.d.) for 52 weeks following 2 weeks to 5 months of treatment in one of four double-blind, placebo-controlled studies. Patients, identified before the double-blind studies, included adults (n=249) not receiving corticosteroids, adults (n=384) and children (n=356) previously maintained on inhaled corticosteroids, and adults (n=144) previously maintained on oral corticosteroids. RESULTS: Mean forced expiratory volume in 1 sec was 68.2% of predicted normal (n=1133) at baseline (mean from two visits before randomization), 74.4% (n=1132) at the end of double-blind treatment, 81.3% (n=971) at week 52, and 80.1% (n=1125) at last observation (including patients who discontinued early). Sixty-four patients maintained on oral corticosteroids before double-blind treatment entered the open-label study off oral corticosteroids, 58 of whom (91%) remained oral corticosteroid-free throughout the study. There was no evidence of basal or cosyntropin-stimulated hypothalamic-pituitary-adrenal axis function suppression, and the most commonly occurring adverse events were respiratory infection, sinusitis, and pharyngitis. CONCLUSIONS: During this 52-week, open-label study, budesonide maintained the improved pulmonary function and decreased oral corticosteroid use observed during previous double-blind treatment and was well tolerated, supporting its long-term use in adults and children with mild to severe persistent asthma.

Formoterol provides long-lasting protection against exercise-induced bronchospasm.

BACKGROUND: Patients with exercise-induced bronchospasm (EIB) may benefit from a prophylactic beta2-adrenergic agonist that combines rapid onset with long duration of action. OBJECTIVE: To compare the protective effect against EIB of a single inhaled dose of formoterol powder delivered via the Aerolizer inhaler (Novartis Pharmaceuticals, East Hanover, NJ) with the effect of placebo and albuterol. METHODS: Eighteen patients with EIB were randomized to treatment in a double-blind, placebo-controlled, four-way, crossover study. Seventeen patients completed all four crossover periods. Each patient received in random sequence a single dose of formoterol (12 or 24 microg), albuterol (180 microg), or placebo at intervals of 5 +/- 2 days. Pulmonary function measurements were taken before and after exercise challenge tests (ECTs) at 15 minutes postdosing and at 4, 8, and 12 hours postdosing. RESULTS: Both doses of formoterol produced significantly greater protection against EIB, compared with placebo, at all timepoints (P < or = 0.016). The two doses of formoterol were not significantly different from one another at any time. Protection against EIB with albuterol was clinically significant only for the 15-minute ECT and was statistically superior to placebo for the 15-minute and 4-hour ECTs. Although formoterol and albuterol exhibited a rapid onset of action, formoterol provided longer-lasting protection over the 12-hour observation period. Rescue medication was used substantially less with either dose of formoterol, compared with albuterol or placebo. All treatments were well tolerated. Two-hour postdosing electrocardiograms and vital signs were unremarkable for all study treatments. CONCLUSION: A single dose of formoterol (12 or 24 microg) provides protection against EIB within 15 minutes of dosing and persists for up to 12 hours. Formoterol is safe and well tolerated.

Comprehensive evaluation of cetirizine in the management of seasonal allergic rhinitis: impact on symptoms, quality of life, productivity, and activity impairment.

Improvement in patient daily functioning and well-being resulting from disease-related symptom relief is increasingly viewed as a clinically relevant therapeutic outcome. The objective of this study was to evaluate the health-related quality of life (HRQL) effects, safety and efficacy of cetirizine in the treatment of seasonal allergic rhinitis, and impact on self-reported work/school-related productivity and activity impairment (WPAI). This was a double-blind, placebo-controlled, parallel-group study. Adult patients (n = 865) were randomized to daily treatment for 2 weeks with cetirizine or placebo. Patient disease-specific HRQL and WPAI were assessed at baseline and weeks 1 and 2 of treatment using the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) and Allergy-Specific Work Productivity and Activity Impairment (WPAI-AS) Instrument, respectively. Treatment with cetirizine resulted in greater (p < 0.001) improvement in overall RQLQ and individual domain scores (activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, emotional), as compared with placebo. Cetirizine therapy produced a 28.9% mean reduction in total symptom severity complex (TSSC) score versus 12.7% with placebo at study end. Work/school productivity and activity impairment were significantly (p < 0.001) decreased from baseline for cetirizine-treated patients compared with placebo. The incidence of treatment-related side effects was similar between groups. Cetirizine provides safe and effective symptomatic relief in adults with SAR while significantly improving HRQL and providing a positive impact on work/school-related productivity and activity impairment. These results provide a more comprehensive assessment of cetirizine, indicating that its benefits extend beyond conventional measures of clinical outcome.