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Asthma is a chronic inflammatory disorder of the airways in which many cells and cellular elements play a role.
The chronic inflammation is associated with airway hyperresponsiveness that leads to recurrent episodes of wheezing, breathlessness, chest tightness, and coughing, particularly at night or in the morning.
Global Strategy for Asthma Management and Prevention, Global Initiative for Asthma, updated 2009
Edema
Adapted from National Asthma Education and Prevention Program. Expert Panel Report. Guidelines for the Diagnosis and Management of Asthma. August 1991.
These episodes are usually associated with widespread, but variable, airflow obstruction within the lung that is often reversible either spontaneously or with treatment. Clinical manifestations of asthma can be controlled with appropriate treatment.
When asthma is controlled, there should be no more than occasional flare-ups and severe exacerbations should be rare.
Global Strategy for Asthma Management and Prevention, Global Initiative for Asthma, updated 2009
Global Strategy for Asthma Management and Prevention, Global Initiative for Asthma, updated 2009
Global Strategy for Asthma Management and Prevention, Global Initiative for Asthma, updated 2009
Asthma Medication
reliever
Rapid acting B2agonist inhaled and oral
Systemic steroid Anticholinergics
controller
Inhaled LABA
Theophylline Cromones
Xanthines
Oral LABA
Medication Routes
1.
2.
3.
Inhalation Medications
BRONCHODILATATION
CHARACTERISTICS OF 2 AGONIST
Onset of Action
Rapid or Slow
Duration of Action
Short or Long
Fast-onset
Long-duration
+ +
+ + + + +
+ + +
Fast onset and full-agonis for reliever Long duration for add on controller
PROCATEROL
Was found by Yoshizaki et al. at Japan in 1976 Procaterol is a potent bronchodilator even on a low dose Has the effect of ten times stronger than salbutamol and terbutalline
TABLET (ORAL)
PROCATEROL
SOLUTIO (NEBULIZED)
35%
15%
0
M5 M30 H1.0 H2.0 H3.0 H4.0 H5.0 H6.0 H7.0 H8.0
M = minute
H= hour
Ref: Storm; W,at.al.1985.Annals of Allergy, 55: 476-478
Initial dose
50 40 30 20 10
Week 12
40
30 20 10
The horizontal (dashed) line represent 15% clinical improvement in FEV1 from baseline.
2000
1600
1400
1200
15
30
300
540 (minute)
The use of long-acting -adrenergic sympathomimetic agent reversed the obstruction of the airway seen in nocturnal asthma
Two puffs of procaterol (20g) or two puffs of salbutamol (200g) MDI PEF, FVC and FEV1 were measured after 5, 15, 30, 60, 120 and 180 min
Changes in mean PEFR, FEV1 and FVC were greater after procaterol than salbutamol The difference in bronchodilatation was not significant
Pengaruh pemberian prokaterol dibandingkan dengan salbutamol secara inhalasi dosis terukur terhadap gejala klinis dan faal paru pada penderita asma
Maimunah, T. Syafiuddin. Jurnal Respirologi Indonesia, 1999
Within the first two weeks, both drugs showed equal efficacy dan clinical improvements
After 2 weeks, the salbutamol group showed deterioration while the procaterol group still showed some improvements
Seventy five (75) cocticosteroiddependent with moderate to severe asthmatic patients Oral or inhaled corticosteroid and procaterol for 28 weeks in five centers
Procaterol has corticosteroid-sparing effect of procaterol without a compensatory increase in bronchodilator use
PURPOSE
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 Patients visiting the Emergency Room of Persahabatan Hospital - Jakarta, male or female, aged 15 to 60 years, were eligible for entry into this study Excluded from the study were pregnant or lactating women, smokers, patients with chronic obstructive pulmonary disease (COPD), heart disease, hyperthyroidism, diabetes mellitus, severe infections, or other chronic diseases
METHODS
Patients were randomly assigned to receive three doses of either nebulized procaterol or salbutamol The primary efficacy variable was the improvement in predicted PEFR, while the secondary efficacy variable was the improvement in asthma score and the incidence and severity of adverse events
RESULT
A total of 156 patients were screened and there were 140 patients eligible for safety evaluation, 137 patients eligible for ITT evaluation and 133 patients eligible for PP analysis (Figure 1)
Procaterol (n=68) VITAL SIGNS Temperature (0C) mean (SD) Heart rate (beats/min) mean (SD) Blood pressure (mm Hg) mean (SD) Systolic Diastolic Respiratory rate (resp/min) mean (SD) PHYSICAL EXAMINATIONS n (%) Normal Abnormal (hyperemic pharynx) ASTHMA SCORE mean (SD) PEFR median (range) PEFR value (L/min) % predicted < 25% - n(%) ARTERIAL BLOOD GAS ANALYSES mean (SD) PaO2 (mm Hg) PaCO2 (mm Hg) SaO2 (%) HCO3- (mEq/L) pH LABORATORY ABNORMALITIES n (%) ECG ABNORMALITIES n (%) 36.9 (0.36) 104.2 (11.7) 121.5 (10.8) 77.9 (8.9) 27.3 (2.6) 64 (94.1) 5 (5.9) 8.8 (1.5) 125 (70 - 300) 30.5 (12 - 57) 19 (27.9)
Salbutamol (n=69) 36.8 (0.48) 102.9 (12.7) 120.0 (9.7) 75.2 (7.0) 27.4 (2.2) 66 (95.7) 3 (4.3) 8.4 (1.6) 120 (80 - 320) 26.0 (15 - 64) 32 (46.4)
75.8 (16.28) 33.9 (6.67) 94.4 (4.37) 22.4 (3.84) 7.4 (0.06) 23 (33.8) 18 (26.5)
79.8 (22.18) 32.8 (5.46) 95.3 (2.66) 21.8 (2.64) 7.4 (0.06) 23 (33.3) 14 (20.3)
Mean PEFR (% predicted) was markedly improved compared with baseline value at every timepoint (20, 40, 60 and 120 minutes) in both groups (Figure 2). Procaterol was statistically better in improving PEFR value at 120 minutes compared with salbutamol but not clinically significant. The minimum clinically significant difference in PEFR improvements between procaterol and salbutamol groups according to the investigators judgment as defined in the protocol was 5%. At other timepoints, PEFR improvements by procaterol was similar to salbutamol
Procaterol (n=68)
Timepoints (minutes)
Salbutamol (n=69)
Figure 2. PEFR (% predicted) values at different timepoints in procaterol and salbutamol groups, ITT population. The improvements from baseline were significant at all timepoints (**p<0.001)
The asthma scores in procaterol and salbutamol groups were markedly improved at every timepoint (20, 40, 60 and 120 minutes) (Figure 3). At 120 minutes, mean asthma score in procaterol group was 2.0 and in salbutamol group was 2.1. Asthma score improvements in procaterol group were compared with those in salbutamol group. It was shown that procaterol gave greater improvements in asthma scores at the first 40 minutes (20 and 40 minutes, p<0.001 and p<0.002, respectively). At 60 and 120 minutes, the asthma scores were consistently lower in procaterol group but not significantly different.
Time (minutes)
Procaterol (n=68)
Salbutamol (n=69)
Figure 3. Asthma scores at several timepoints in procaterol and salbutamol groups, ITT population. The improvements from baseline were significant at all timepoints (** p<0.001 )
Arterial blood gas analyses at 120 minutes are summarized in Table 2. Number of patients analyzed for blood gas was 62 patients in procaterol group and 65 patients in salbutamol group. Six patients in procaterol group and 3 patients in salbutamol group could not be included in the blood gas analysis due to the missing data on either at baseline or at 120 minutes. Overall, PaO2 in procaterol group was slightly increased, while it was slightly decreased in salbutamol group. SaO2 was unchanged in procaterol group and slightly decreased in salbutamol group, while PaCO2 slightly decreased in both procaterol and salbutamol groups
Table 2. Mean PaO2, PaCO2 and O2 saturation (SaO2) before and after treatment (120 minutes) in procaterol and salbutamol groups, PP analysis
PP analysis Blood Gas Analysis PaO2 (mmHg) SaO2 PaCO2 (mmHg) 0 minutes 120 minutes 0 minutes 120 minutes 0 minutes 120 minutes Procaterol (n=62) 76.8 81.4 95.0 95.0 33.4 31.6 Salbutamol (n=65) 80.0 76.2 95.3 94.3 32.8 31.7
Adverse events
Incidences of adverse events were very low in the present study. Adverse events recorded were sinus tachycardia and palpitation, which were common after 2 agonist administration. Palpitation was recorded as a subjective symptom. There were 2 subjects in salbutamol group experienced palpitation, and no one in procaterol group. The palpitation was considered as mild. Sinus tachycardia was found during electrocardiography at 120 minutes, which was recorded and analyzed for any changes from baseline. There were 2 (2.9%) cases of changes in ECG recordings in procaterol group and 6 (8.6%) cases in salbutamol group. No serious adverse event was found in the present study
CONCLUSIONS
Beta 2 agonists have been used as reliever in asthma management In moderate acute asthma, nebulized procaterol and nebulized salbutamol were both effective in improving PEFR and decreasing asthma score. Both treatments were well tolerated, and adverse reactions were rare, lower incidence with procaterol than with salbutamol