Efficacy of procaterol combined with inhaled budesonide for treatment of cough-variant asthma.

BACKGROUND AND OBJECTIVE: Procaterol, a selective, short-acting beta-2 adrenoceptor agonist, is effective in treating 'classical' asthma, but its efficacy for cough-variant asthma (CVA) is unknown. We evaluated the efficacy and safety of procaterol combined with budesonide for CVA. METHODS: A prospective, randomized, double-blind, placebo-controlled, multicenter trial in China was conducted. One hundred and fifty-nine patients diagnosed with CVA (aged 18-75 years) were randomly divided into two groups to receive twice daily for 8 weeks, inhaled budesonide 100 µg plus either oral procaterol 25 µg or placebo. Primary and secondary efficacy variables were cough symptom severity scores and Leicester Cough Questionnaire (LCQ) life quality scores. Adverse events were also assessed. RESULTS: The budesonide/placebo and budesonide/procaterol groups contained 80 and 78 participants (one excluded for later diagnosis of eosinophilic bronchitis), respectively, with similar baseline characteristics. Daily cough score declined during treatment in both groups and was lower in the budesonide/procaterol group at 8 (0.44 vs 0.73) and 10 (0.36 vs 0.69) weeks (P < 0.05). Compared with the budesonide/placebo group, the proportion of patients with a reduction of 3 points or greater (66% vs 42%) and that of patients scoring 0 points (63% vs 51%) was higher in the budesonide/procaterol group for daily cough scores (P < 0.05). At 8 weeks, LCQ score improvement was superior in the budesonide/procaterol group (38.94 ± 19.24 vs 32.71 ± 18.92; P < 0.05). CONCLUSION: Procaterol combined with budesonide was well tolerated and effective at improving cough symptoms and quality of life in patients with CVA.

The efficacy of nebulized procaterol versus nebulized salbutamol for the treatment of moderate acute asthma: a randomized, double-blind, parallel group study.

OBJECTIVE: ß2 agonists have been used widely as relievers in asthma management. Procaterol is a selective ß2 agonist, claimed to be more selective than salbutamol. The present study aimed to compare the efficacy of nebulized procaterol with nebulized salbutamol in the treatment of moderate acute asthma. METHODS: This was a randomized, double-blind, parallel group study in 140 patients with moderate acute asthma according to modified GINA 1998 who visited emergency department of Persahabatan Hospital, Jakarta. Patients were randomly assigned to receive three doses of either nebulized procaterol or salbutamol. The primary efficacy variable was the improvement in predicted peak expiratory flow rate (PEFR), while the secondary efficacy variable was the improvement in asthma score and the incidence and severity of adverse events. This study is registered at Current Controlled Trials, number ISCTRN25669625. RESULTS: Baseline characteristics were similar in both groups. After treatment, there were significant improvement of % PEFR (p < 0.001) and asthma score (p < 0.001) in procaterol (n = 68) and salbutamol (n = 69) groups. It was shown that procaterol and salbutamol produced similar efficacy in improving % predicted PEFR and decreasing asthma score. Both treatments were well tolerated. Palpitation and sinus tachycardia were found as adverse events with low incidence. CONCLUSION: In moderate acute asthma, nebulized procaterol and nebulized salbutamol were both effective in improving PEFR and decreasing asthma score. Both treatments were well tolerated, adverse reactions were rare.

Long-term effect of the beta2-receptor agonist procaterol on daily life performance and exercise capacity in patients with stable chronic obstructive pulmonary disease. Clinical study with special reference to health-related quality of life and activities of daily living.

The present study was undertaken to evaluate the long-term effect of procaterol hydrochloride (CAS 62929-91-3, Meptin), a third generation beta2-receptor agonist on lung function, exercise capacity, health-related quality of life (HRQOL) and activities of daily living (ALDs) in patients with stable chronic obstructive pulmonary disease (COPD). Twenty patients were randomly assigned to the procaterol group or to the control group, who received oxitropium bromide (CAS 30286-75-0), an anticholinergic agent. Procaterol was inhaled three times a day at a dose of 20 pg, while oxitropium was inhaled three times a day at a dose of 200 microg. The subjects were evaluated based on spirometry, exercise capacity, the Borg Scale, HRQOL, and ADLs before and after 12, 24 and 52 weeks of therapy. The values of forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), total lung capacity (TLC), functional residual capacity (FRC), residual volume (RV), maximal inspiratory pressure (PImax), and maximal expiratory pressure (PEmax) were significantly improved at 12, 24 and 52 weeks compared with baseline values in the procaterol group (p < 0.05, p < 0.01), while these values did not differ from baseline values at any point in the oxitropium group (p > 0.05). Additionally, 6-min walking distances and Borg Scale values showed significant improvement at 12, 24 and 52 weeks compared with baseline values in the procaterol group (p < 0.05, p < 0.01), but did not significantly differ from baseline values in the oxitropium group at any point (p > 0.05). Likewise, the scores for dyspnea, fatigue, emotional function, mastery, total scores and ADLs were significantly higher at 12, 24 and 52 weeks compared with the baseline values in the procaterol group (p < 0.05, p < 0.01), but did not differ at any point in the oxitropium group (p > 0.05). These results suggest the effectiveness of long-term regular bronchodilator therapy with the beta2-receptor agonist procaterol in patients with stable COPD.

[Therapy with nebulized beta2 agonists (procaterol) in asthmatic children: pulmonary function and plasma levels after inhalation].

BACKGROUND: Relationship between post administrative changes in plasma drug levels and bronchodilation remains unknown. In this study, we measured plasma levels of procaterol, a beta2-agonist, when being inhaled through nebulizers in children with bronchial asthma to examine relationship between improvement of pulmonary function and the plasma levels. METHOD: Six asthmatic children with the mean age of 9.8 years, inhaled 0.3 ml of 0.01% procaterol solution through a nebulizer. We examined changes in pulmonary function and plasma procaterol levels before and after inhalation. RESULTS: Procaterol was detected in the plasma 2 minutes after inhalation when it already rose to the maximum level, and kept the steady until showing a decline in 30 minutes. The measured highest value was 87.8+/-45.1 pg/ml. FEV 1.0 remarkably increased 2 minutes after inhalation and was maintained until 60 minutes after inhalation. Other lung function parameters also improved. There was no significant change in the heart rate, but serum potassium concentrations significantly dropped in all patients 60 minutes after inhalation. CONCLUSION: Plasma procaterol levels promptly rose to the peak at 2 minutes after inhalation and decreased 30 minutes later. Improvement of pulmonary function started promptly at minutes after inhalation and it became a peak 60 minutes later.

[Bronchial asthma attack with lactic acidosis and hypokalemia in a case receiving high dose inhalation of procaterol hydrochloride].

We report a case of bronchial asthma attack with lactic acidosis and hypokalemia in a patient receiving high-dose inhalation of procaterol hydrochloride. A 28-year-old man was transferred to our hospital because of adynamia, nausea and dyspnea. He had used inhaled procaterol hydrochloride with a pressurized metered dose inhaler about 20 times before admission. On admission, there were no signs of shock state or hypoxemia and laboratory data showed hypokalemia, hyperglycemia and metabolic acidosis with elevated anion gap. Lactic acidosis was identified as the reason for the metabolic acidosis with elevated anion gap. Lactic acidosis improved after 12 hours. Lactic acidosis due to high dose inhalation of procaterol hydrochloride was suggested.

Safety and usefulness of a novel eMotion electric mesh nebulizer in children with asthma.

BACKGROUND: A new electronic mesh nebulizer, eMotion is known to have higher performance compared to conventional nebulizers. However, there are some concerns about whether too much delivered dose might cause side effects with higher frequency. METHODS: To evaluate the safety and usefulness of the nebulizer, we measured changes in heart rates and lung functions of 73 asthmatic children when they inhaled 1 microg/kg of procaterol with eMotion or a conventional nebulizer, Junior BOY. RESULTS: In 34 children with mild asthma exacerbation, physical findings, lung function and transcutaneous oxygen saturation levels were improved after inhalation using both nebulizers. No adverse effects including significant increase of heart rate were found. Improvements in the rates of the parameters were comparable. When response to beta2-agonist inhalation was checked in 39 children in stable condition, similar degrees of improvement in lung function were observed, and heart rates did not change after inhalation with either nebulizers. CONCLUSIONS: Safety and efficacy was comparable between eMotion and a conventional nebulizer when it was used to administer beta2-agonists in asthmatic children. However, from the fact that eMotion needs only 3-4 minutes to inhale 2 mL solution, eMotion could be more useful for most children who usually do not prefer longer inhalation time with conventional compressor nebulizers.

[Long-term effects of inhaled beta 2-agonists on bronchial hyperresponsiveness in asthmatics].

We examined the effects of two year's treatment of three inhaled beta 2-agonists (beta 2), such as salbutamol (S), procaterol (P) and fenoterol (F) on acetylcholine induced bronchial hyperresponsiveness (BHR) in mild approximately moderate asthmatics. When symptomatic use of beta 2 were less than 6 puffs/day, BHR was improved significantly with both S and P but was not with F. When more than 6 puffs/day, all three beta 2 did not show the improvement of BHR. Without the effect of corticosteroids, BHR was improved with S, and was partially improved with P in case of only less than 6 puffs/day, but was not improved with F unrelated to the inhaled puff number. Therefore, frequent use of beta 2 even if used only on demand was shown to worse BHR, asthmatics must be controlled to under the good condition of using beta 2 at least less than 6 puffs/day.

Prolonged bronchodilating effect of formoterol versus procaterol in bronchial asthma.

The tolerability and the duration of effect of 12 micrograms of formoterol and 25 micrograms of procaterol administered via metered-dose aerosol to 12 stable asthmatic patients were evaluated in a double-blind, placebo controlled trial. FEV1, pulse rate, and blood pressure were measured at baseline and every two hours after dosing for 12 hours. The bronchodilation peak was observed after two hours for both drugs. Formoterol induced a significant bronchodilating effect for 12 hours compared with both baseline and placebo values. With procaterol, significant bronchodilation occurred for six hours compared with baseline values and four hours compared with placebo. No significant changes were observed in pulse rate and blood pressure with either drug. Four subjects complained of muscle tremor after procaterol administration. We conclude that in subjects with stable asthma, inhaled formoterol at a dose of 12 micrograms maintains significant bronchodilation for 12 hours after dosing and is very well tolerated. Further studies are required to evaluate effectiveness and tolerability of high dose formoterol treatment in acute severe asthma therapy.

[Clinical evaluation of procaterol and salbutamol in patients with bronchial asthma]. / Kliniczna ocena prokaterolu i salbutamolu u chorych na astme oskrzelowa.

When the beta-2-selectivity of beta-agonists is assessed in man it is always considerably less than would be expected from studies on isolated tissues. That was a reason why this study was taken. As we know procaterol has been included into group of beta-2-selective non-catecholamines with a reasonably long duration of action. We performed clinical evaluation of procaterol and salbutamol on 24 patients with bronchial asthma. Procaterol was administered per os (tabl. a 50 micrograms twice daily) during 4 weeks, and next salbutamol was replaced above mentioned (tabl. a 8 mg twice daily) also during 4 weeks. Clinical symptoms and spirometric values were analyzed. Obtained results indicated that procaterol and salbutamol showed a similar potency in spirometric examination in patients with bronchial asthma. Observed side effects after procaterol were less often than after salbutamol.