Public Assessment Report for paediatric studies submitted in ...

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exercise were plotted. The maximum absolute fall and maximum percentage fell in PEFR on each treatment and for each subjects was calculated and the mean values recorded. In both studies was observed a typical pattern of EIA following placebo. PEFR fell rapidly during the first minute post exercise and continued to fall for 5 minutes before slowly starting to increase back to baseline. All treatments were more effective than placebo regarding the inhibition of EIA. In study 1 both nebulised salbutamol and SCG administered individually were highly significantly more effective than placebo (p < 0.001), but salbutamol was seen to provide a significantly greater protection than SCG (p0,1). In study 2 the dry powder SCG was significantly better than placebo (p< 0.01) and significantly less effective than salbutamol dry powder (p
The improvment in PEF was 51 L. min.-1 for JN and 27 L.min -1 for PMDi at 30 minutes (p= 0.0007) and 57 L. min .-1 for JN and 31,5 L.min -1 for PMDi at 60 minutes (p= 0.001). Conclusion was that the administration of salbutamol by PMDi with a large volume spacer device provides effective relief in the management of acute asthma in children, but to a lesser extent than a jet nebuliser. The difference may represent a dose response effect. Study SBM 40140 (505/250) Duble-blind, randomized, controlled is a subset of a large trial carried out in 275 children aged 3 to 17 years entitled „A randomized controlled trial using objective assessment of airway obstruction in the treatment of acute asthma in preschool children” (Ducharme F.M., Davis G.M., Montreal, Canda, 1998). Objective - to compare the efficacy of salbutamol deliverded by JN vs. salbutamol delivered by PMDi with a large volume spacer (Volumatic) for managment of acute asthma in children. In this study were compared 4 different nebulised inhaled salbutamol in 112 children aged 3 to 6 years with acute asthma. Treatments - following an initial inhalation of salbutamol patients were randomised to one of these 4 treatment schedules: - salbutamol high dose every hour, - salbutamol low dose every 30 minutes, - salbutamol high dose every hour + a single dose of ipatropium bromide - salbutamol low dose every 30 minutes + a single dose of ipatropium bromide. Results On arrival the mean % predicted resistence by forced oscillation (Rfo) was 76 (102, 255) and SaO2 was 95% (88, 100) Rfo improved significantly between baseline and at 90 minutes for all treatments (p < 0.001) and SaO2 improved in the 45 patients with an initially low SaO2 (p= 0.001). There was no difference among the 4 treatments: salbutamol frequent low dose (SFLD) vs. SH (p= 0,28), IB vs. SH (p= 0,41). There was no synergy between SFLD + IB (p= 0,94). Salbutamol in frequent low dose was associted with increasd vomiting. Conclusion was that in preschool children with mild and moderate asthma more frequent low dose of salbutamol did not results in greater improvment in Rfo and SO2 than hourly high dose of salbutamol. The results do not support the use of frequent low dose of nebulised salbutamol or the addition of ipratropium bromide compared to hourly high dose of salbutamol in children with mild and moderate asthma. Assessor’s comment: The findings of small studies RID/CT/69 and D37/A24 conducted approximately 20 years ago in the mid 1980s do not provide sufficient evidence to justify change to the product information. The results of studies SBM 40140 (505/250) and SBM 40122 (Neb 02) conducted in the mid 1990s have no impact on product information 2.2 Oral Administration 2.2.1 Controlled–release tablets and tablets SCR4/85/CPI Study Report GMR/86/008 Double blind parallel group comparison of controlled–release Salbutamol tablets 4mg bd with standard Salbutamol tablets 2mg qd in the management of reversible airways obstruction in children“ Objective - to investigate the efficacy of controlled-release Salbutamol 4mg twice daily with standard Salbutamol tablets 2mg four times a day in children aged 3 to 16 years. Study design - randomized controlled, double blind, parallel group trial, carried out in 16 hospital centres. Salbutamol Final Public Assessment Report RO/W/0001/pdWS/001 Page 39/76
Page 1 and 2: Public Assessment Report for paedia
Page 3 and 4: Pharmacovigilance and PSUR Name: Da
Page 5 and 6: Rapid-acting inhaled β 2 -agonists
Page 7 and 8: The MAHs are requested to submit a
Page 9 and 10: Neonatal onset of symptoms (associa
Page 11 and 12: Study Code: RID/CT/84 (D140/B16); D
Page 13 and 14: of predicted FEV1 to be 12%, the re
Page 15 and 16: central laboratory where this clini
Page 17 and 18: DISKUS 200 mcg compared to albutero
Page 19 and 20: Study period 25 Nov 1996 - 28 May 1
Page 21 and 22: Investigational products for this s
Page 23 and 24: 180mcg 1 inhalation of 90mcg (Can B
Page 25 and 26: Efficacy results Primary efficacy v
Page 27 and 28: At Week 4, mean changes from baseli
Page 29 and 30: In the ITT population the daytime a
Page 31 and 32: This study demonstrated similar saf
Page 33 and 34: Protocol deviations were summarised
Page 35 and 36: The overall (based on all evaluable
Page 37: Three studies regarding the clinica
Page 41 and 42: eported by the ≤ 6 year age group
Page 43 and 44: suitable for this age because young
Page 45 and 46: In the group treated with salbutamo
Page 47 and 48: common complaints associated with h
Page 49 and 50: although being gradually replaced b
Page 51 and 52: Based on the data submitted, the MA
Page 53 and 54: Inhaled Table 1 Key Differences bet
Page 55 and 56: GDS wording National SmPCs with sig
Page 57 and 58: GDS wording National SmPCs with sig
Page 59 and 60: Question 4 (Rapporteur): With regar
Page 61 and 62: Question 3 In case of divergences b
Page 63 and 64: United Kingdom: Salbulin MDPI Novol
Page 65 and 66: 2. Completely depress the coloured
Page 67 and 68: The harmonised SmPC as outcome of t
Page 69 and 70: Assessment of the Applicant’s res
Page 71 and 72: SALBUTAMOL WZF POLFA 2 mg SALBUTAMO
Page 73 and 74: symptoms. Increased consumption of
Page 75 and 76: sympathomimetic amines. High doses

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