In a double-blind, randomized, parallel-group clinical trial, 340 asthmatic patients aged 12-70 years received budesonide 400 micrograms once daily in the morning, budesonide 400 micrograms once daily in the evening, budesonide 200 micrograms twice daily or placebo, for 12 weeks in addition to inhaled short-acting beta 2-agonists used as required (p.r.n.). Budesonide was given as Pulmicort Turbohaler. Peak expiratory flow rate (PEFR) increased by 20 to 30 1 min-1 in each of the active treatment groups, significantly more than in the placebo group (P < 0.01). There were no significant differences between the active treatment groups. Symptom improvement and decreased beta 2-agonist use reflected the PEFR data. Incidences of adverse events in the active treatment groups were similar to those observed in the placebo group. Budesonide 400 micrograms given once daily morning or evening is equieffective with the same total daily dose given twice daily in the treatment of mild to moderate stable asthmatics.

The efficacy and safety of ciclesonide was assessed in this randomized, placebo-controlled study in patients with persistent asthma (randomized n=360) maintained on low to moderate doses of inhaled corticosteroids. Patients were randomized to receive ciclesonide 80 or 320 microg (ex-actuator doses, equivalent to 100 and 400 microg ex-valve, respectively) or placebo once daily in the morning via metered-dose inhaler for 12 weeks. Morning peak expiratory flow was maintained throughout the treatment period in patients treated with ciclesonide and decreased significantly in patients treated with placebo (P=0.0003). Ciclesonide (80 and 320 microg) significantly increased forced expiratory volume in 1s from baseline (0.13 and 0.19 L increases, respectively; P<0.01); improvements were superior versus placebo (P=0.0044 for 80 microg ciclesonide; P<0.0001 for 320 microg ciclesonide). The probability of losing efficacy decreased in a dose-dependent manner (55% for placebo, 38% for ciclesonide 80 microg, 23% for ciclesonide 320 microg). Asthma symptom scores and rescue medication use were unchanged with ciclesonide and significantly worsened with placebo. The incidence of adverse events was comparable in all treatment groups and no cortisol suppression was observed. Therefore, ciclesonide 80 and 320 microg administered once daily was a safe and effective maintenance treatment for patients with persistent asthma.

It remains unanswered whether persistent allergic inflammation in nasal mucosa alters bacterial colonization and infection. The aim of this study was to investigate the bacterial flora in the nasal cavity of patients with persistent allergic rhinitis (PAR) and to correlate the bacteriological findings with presence of nasal symptoms, nasal eosinophil and neutrophil counts. A total of 255 subjects, aged between 6-74 years (mean 33.9 years) was randomly selected from a population-based rhinitis survey study in Singapore. All subjects went through a thorough medical history and nasal examinations. Serum specific IgE to a panel of common house dust mites, nasal cytological and microbiological examinations were performed. PAR was diagnosed in 107 patients and none of them had received previous regular therapy. There is a significant relationship between PAR and eosinophil grades, but not with neutrophil count. No statistically significant difference was found in quantitative and qualitative bacterial flora in nasal cavity between PAR patients and subjects with non-rhinitis or with non-allergic rhinitis. There is a significant inverse correlation between ongoing rhinorrhoea and quantitative bacterial load, and between signs of nasal mucosa (pale and edema) and the presence and type of bacterial pathogens. In conclusion, our study demonstrates that patients with untreated (or using PRN medicine) PAR do not result in a significant change in bacterial flora in their nasal cavity.

A randomized, double-blind, double-dummy crossover study on 42 asthmatics was carried out to compare the single dose effects of salbutamol administered from the widely used metered dose inhaler and a breath operated system (Diskhaler). The bronchodilator response (change in forced expiratory volume in the first second) was almost identical for the two systems. The Diskhaler system however, since it is breath operated, obviates the need for hand-breath coordination.

The efficacy and tolerability of a new dispersible formulation of diclofenac were evaluated in a randomized, double-blind, placebo-controlled, multi-centre study inpatients aged 60 to 80 years suffering from osteoarthritis. A total of 314 elderly patients with a mean age of 68.9 years received either50 mg diclofenac dispersible or placebo 3-times daily for a period of 4 weeks, with paracetamol being allowed as rescue analgesic for both treatment groups. The study consisted of a baseline evaluation and two follow-up visits after 14 and 28 days of treatment. The following clinical parameters were assessed: pain at rest, on movement and on local pressure; global severity of pain; effect of pain on dairy activity; duration of stiffness after immobility; rescue analgesic consumption; overall opinion of the investigator on efficacy; and occurrence of adverse events. At either one or both post-treatment assessments, diclofenac dispersible was found to be significantly superior to placebo for almost all measures of efficacy (pG0.05). Thirty (14.4%) patients out of 208 assessed in the diclofenac group reported adverse events compared to 18 (1 7%) out of 106 who receivedplacebo; therapy was discontinued prematurely due to poor tolerability in 4.8% and 5.7% of patients, respectively. The adverse events were predominantly related to the gastro-intestinal system and were mostly mild to moderate in severity. The results of this 4-week study thus demonstrate that diclofenac dispersible is not only effective in treating osteoarthritis in the elderly but also has an acceptable tolerability profile in a patient population which is especially vulnerable to adverse effects induced by nonsteroidal anti-inflammatory drugs.