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Beclomethasone Dipropionate Versus Budesonide Inhalation Suspension in Children with Mild to Moderate Persistent Asthma

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Beclomethasone Dipropionate Versus Budesonide Inhalation Suspension in Children with Mild to Moderate Persistent Asthma European Review for Medical and Pharmacological Sciences 2000; 4: 17-24 Beclomethasone dipropionate versus budesonide inhalation suspension in children with mild to moderate persistent asthma C. TERZANO*, L. ALLEGRA**, L. BARKAI***, G. CREMONESI *”La Sapienza” University - Rome (Italy) **Policlinico Hospital, University of Milan Medical School - Milan (Italy) ***Pediatric Clinic - Miskolc (Hungary) Chiesi Farmaceutici - Parma (Italy) Abstract. – Inhaled steroids are the Key Words: most effective long-term treatment of persis- tent asthma but many children are unable to Asthma, Beclomethasone dipropionate, Budesonide, use correctly the available inhalers. Nebulized drugs. Administration of nebulized corticosteroids has some advantages over the administration with pressurised metered-dose inhalers (pMDIs). The objective of this multicenter ran- domised study was to compare the efficacy Introduction and tolerability of nebulized corticosteroids in paediatric patients with asthma. 127 patients aged ≥ 6 and ≤ 14 years with a diagnosis of mild to moderate persistent asthma (PEFR % Asthma is one of the most frequent dis- predicted > 50% and < 85%) and positive re- eases, especially in children; it is estimated sponse to the reversibility test were random- that it can affect 4-10% of the paediatric pop- ized. The patients were assigned by randomi- ulation in the world1. The prevalence of the sation to one of the two treatment groups (4 disease has increased, together with its mor- weeks): beclomethasone dipropionate (BDP) bidity, as demonstrated by the increase of 800 µg/daily b.i.d. (n = 66) or budesonide (BUD) 2 1000 µg/daily b.i.d (n = 61) both administered hospitalisations due to asthma . Inhaled corti- by nebulizer. The primary efficacy end point costeroids are the most effective medication was the final mean of PEFR measured at clini- for the long-term control of persistent cal visit (clinic PEFR). In the BDP group clinic asthma1. Their anti-inflammatory activity is PEFR increased from 177.5 ± 80 L/min to 246.6 responsible for the therapeutic effect and for ± 84.2 L/min (p < 0.001vs baseline), while in the the control of asthma symptoms, improve- BUD group the increase was from 180.4 ± 77.8 L/min to 260.9 ± 84.1 L/min (p < 0.001 vs base- ment of pulmonary function and reduction of exacerbation1. line) (NS between treatments). FEV1 (% predict- ed) increased from 77.8% to 92.7% (p < 0.001 There are a number of different aerosol vs baseline) and from 74.1% to 95.9% (p < delivery system such as pressurised metered- 0.001 vs baseline) in BDP and BUD group re- dose inhalers (pMDIs), with or without add spectively (NS between treatments). Patients on devices, dry powder inhalers (PDI) and reduced the use of salbutamol rescue medica- nebulizers. The first class of drugs used in the tion by 76% and 81% in BDP and BUD group β respectively (p < 0.001 vs baseline, NS be- nebulized form was the 2-agonist bron- tween treatments). 4 patients in the BDP group chodilators, followed by the use of nebulized and 2 in the BUD group reported adverse corticosteroids and anticholinergics. This events (AEs). AEs were mild to moderate and mode of administration has an important role never there was the need to discontinue the for some types of patients and especially chil- treatments. In conclusion the results of this dren who cannot properly use pMDIs or DPI. study demonstrate that both BDP (800 µg/dai- ly) and BUD (1000 µg/daily) administered by In fact, the use of nebulized products can nebulization are effective and with a accept- overcome coordination problems associated able safety and tolerability profile. with the use of a pressurised aerosol3,4. Direct 17 C. Terzano, L. Allegra , L. Barkai, G. Cremonesi comparison between beclomethasone dipro- study, oral prednisone 1 mg per kg body pionate (BDP) and budesonide (BUD) sus- weight was allowed. After a one-week run-in pension for nebulization has never been re- period, in which each patient continued the β ported. The purpose of the study was to com- use of previous treatment and 2 agonist as pare the efficacy and the safety of BDP and needed, the patients who met inclusion and BUD inhalation suspension in children with exclusion criteria were assigned to one of the mild to moderate asthma. two treatment groups for a treatment period of 4 weeks. During the treatment a visit every 2 weeks was planned. Lung function was evaluated according to Material and Methods the American Thoracic Society Guidelines5. A standard spirometer was used; the calibra- Male and female aged ≥ 6 and ≤ 14 years tion had to be controlled each day of use. who had clinical diagnosis of persistent asth- Clinic PEFR was evaluated from the flow/vol- ma as defined by the National Heart Lung ume curve ratio or from the forced expiratory and Blood Institute with PEFR value > 50% manoeuvre. Within three different measure- β and < 85% of the theoretical value and posi- ments the best was reported. The use of the 2 tive response to the reversibility test, defined agonists had to be withdrawn at least 8 hours as an increase > 15% in the FEV1 measured before the test. The time of lung tests was 30 minutes following 1 puffs (1 × 100 µg) of recorded in order to perform the tests at the inhaled salbutamol, were eligible to partici- same hour for all the study long, with a varia- pate in the study. Patients treated with oral tion equal to ± 1 hour. Morning and evening steroids in the previous 12 weeks for more PEFR were measured daily by patients using than 12 days, with history of clinically signifi- a Mini-Wright Low Range peak flow meter cant hepatic disease (transaminasis 2 times (Clement Clarke International – Harlow, higher than the normal value) or renal im- Essex. England), always at the same hour of pairment (creatinine ≥ 1.5 mg/dl), with heart the day (8 ± 1 am, 7 ± 1 pm whenever possi- failure, active peptic ulcer, active mycotic in- ble). Three measurements were performed fection of the lung, tuberculosis, herpes sim- and the highest of the three values recorded plex, insulin dependent diabetes mellitus, hy- in the diary card. The measurement was done perthyroidism, hypersensitivity to the study before any use of bronchodilator inhaler. drugs were excluded from the randomisation. Global asthma symptoms, rated on 0 to 4 scale (0 = no present, 4 = so severe that the Study design patient could not attend school or carry out Patients who met inclusion and exclusion normal activities) and bronchodilator use criteria were assigned by randomisation to were assessed on a daily basis by the patients one of the two-treatment group: BDP 800 and recorded into the diary card. The institu- mg/daily b.i.d. (Clenil® A – Chiesi tional review board for each treatment centre Farmaceutici S.p.A. – Parma, Italy) or BUD approved the protocol, and the written in- 1000 mg/daily b.i.d. (Pulmicort® Respules - formed consent was obtained from the parent Astra Pharmaceuticals Ltd. Kings Langly, or guardians of patients. Hertfordshire, England) commercially avail- able. Both drugs were administered by a Pari Assessments Boy nebulizer (Pari GmbH, Starnberg, The primary efficacy end point was defined Germany). Drugs that could interfere with as the final mean of clinic peak expiratory flow the study treatment were excluded: anti- rate (PEFR) before bronchodilator use. cholinergics, inhaled (including nasal) corti- Secondary efficacy end-points were the final costeroids or oral corticosteroids, long acting mean values of forced expiratory volume in inhaled bronchodilators, oral bronchodila- one second (FEV1), forced vital capacity tors, cromoglicate-like drugs, antihistamines, (FVC), improvement of asthma symptoms, pa- β β leukotrienes antagonists, -blockers. The use tients/parents opinion, consumption of 2 ago- β of short acting 2 agonist was permitted when nists and morning peak expiratory flow rate necessary. If inhaled therapy didn’t obtain a (PEFR) measured by the patient. Adverse good control of the symptom during the events were assessed throughout the study. 18 Beclomethasone dipropionate versus budesonide inhalation suspension in children Statistical analysis dence interval of mean change at each visit Sample size calculation was based on the from baseline. Between treatment compari- criteria of equivalent efficacy between the two son was done as for primary efficacy variable. treatments6. Considering as primary efficacy Patient’s/parents’ opinion was evaluated us- variable the final mean value of clinic PEFR, ing Chi-square test. Adverse events, as re- considering as clinically not relevant a differ- ported on the case report forms, were listed ence between groups not superior of 10% of by treatment and by patient. the BUD mean PEFR, considering the BUD All randomized patients who received at mean PEFR value after 4 weeks equal to 270 least one dose of the study medications and L/min, considering the common standard de- with at least one visit after baseline were to viation of PEFR equal to 55, with a sample of be included in the ITT population analysis. 61 patients per group a one side test with α = Missing data were to be replaced with the 0.05 should have a 80% potency to refuse the “last observation carried forward” method. null hypothesis that BDP and BUD are not All patients included in ITT population who equivalent in favour of alternative hypothesis also meet all inclusion/exclusion criteria and that the two groups are equivalent. who do not have any major protocol violation Basal values comparison was done by a were to be included in the per protocol popu- one way ANOVA for continuous variables, lation (PP) and analysis. Intention-to-treat and by Wilcoxon 2-sample test or Chi-square population was used as primary analysis for test for categorical variables.
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