Public Assessment Report for paediatric studies submitted in ...

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Ventolin Nebules may be diluted with sterile normal saline. Solutions in nebulisers should be replaced on a daily basis. Easyhaler Salbutamol Sulphate 100 micrograms and 200 micrograms per actuation inhalation powder The multidose powder inhaler (Easyhaler) consists of seven plastic parts and a stainless steel spring. The starting package contains an inhaler and a protective cover. The maintenance pack contains the dry powder inhaler only. Pack size: 200 actuations. With the powder inhalers the patient first actuates the device and the dose is ready to be inhaled with forced and prolonged inspiration. Diskus/Accuhaler is a multi-dose dry powder inhalation device plastic inhaler containing a foil strip with 60 regularly spaced blisters, each containing a mixture of 200 micrograms of microfine salbutamol (as sulphate) and larger lactose particles. The powder mix of salbutamol (as sulphate) and lactose is filled into a blister strip consisting of a formed base foil with a peelable foil laminate lid. The foil strip is contained within the Accuhaler device. The powdered medicinal product is inhaled through the mouth into the lungs. The Accuhaler device contains the medicinal product in individual blisters which are open as the device is handled. IV.2 Non-clinical aspects Non-clinical studies have not been provided or summarized by the MAHs on salbutamol sulphate. It is noted that no literature review has been conducted by the MAHs to identify preclinical studies relevant for the paediatric use of this active substance. IV.3 Clinical aspects A) Summary of clinical program sponsored by GSK 1. Introduction The MAH submitted reports for the following 18 completed paediatric studies: Study Code: SALA3008; SALA2003 Study Title: Ventolin Diskus Safety/Efficacy studies in 4-11 year olds GSK Study Report Number: Report Nos. RM1997/00754/00 and RM1998/00055/00 Study Code: SALA3006; SB030003; Study Title: Ventolin Evohaler studies in over 4 year olds GSK Study Report Number: Report Nos. RM1997/00818/00 and RM2004/00133/00 Study Code: SB020001; SB030001, SB030002 Study Title: Ventolin Evohaler studies in under 4 year olds GSK Study Report Number: Report Nos. RM2003/00584/00; RM2004/00507/00; RM2006/00188/00; Study Code: SBM40122(Neb02); SBM40140 (505/250) Study Title: Ventolin Nebules studies GSK Study Report Number: Report Nos. Publications only Study Code: RID/CT/69; D137/A25 Study Title: Ventolin Nebules and Rotadisk exercise-induced asthma study GSK Study Report Number: Report Nos. GPM/84/001 Salbutamol Final Public Assessment Report RO/W/0001/pdWS/001 Page 10/76
Study Code: RID/CT/84 (D140/B16); D78/B24 Study Title: Ventolin Injection/Intravenous studies GSK Study Report Number: Report Nos. GPM/84/024; GPM/85/008 Study Code: SCR4/85/CPI; STC388; SBM40056; SBM40107 Study Title: Ventolin/Volmax Tablets studies GSK Study Report Number: Report Nos. GMR/86/008; GRP/88/013; Publication only Study Code: BIO/75/09 Study Title: Ventolin Suppository study GSK Study Report Number: Report No. BIO/75/09 2. Clinical studies 2.1 Oral Inhalation A separation was made between Salbutamol pMDI (Ventolin Evohaler (CFC-Free Inhaler, Ventolin HFA inhalation aerosol) and Salbutamol DPI (Rotadisks/Rotacaps Accuhaler/Diskus, Pulmicort Turbuhaler) and Salbutamol nebuliser suspension (Ventolin Nebules). The three types will be completely discussed separately at once. device. 9 clinical studies were submitted. An overview is presented in the part concerning the specific 2.1.1 Inhalation powder The first powder form of albuterol, VENTOLIN ROTACAPS (albuterol sulfate, USP) for Inhalation, delivered via the ROTAHALER device was approved for marketing outside the U.S. in 1977 and in the U.S. in 1988. The powder form of albuterol was also marketed outside the U.S. in a new delivery system known as VENTOLIN ROTADISK (albuterol sulfate, USP) with the DISKHALER device in 1987. The most recent powder delivery system, DISKUS, was approved for marketing with albuterol outside the U.S. in 1995. Two studies which had not been previously submitted regarding the clinical efficacy and safety of salbutamol Diskus in paediatric patients are assessed (SALA3008 and SALA2003): Study Code: SALA3008 Study Title: A Randomized, Double-blind, Double-Dummy, Parallel-Group, Clinical Trial Assessing the Safety and Efficacy of Albuterol Powder 200 mcg QID via the DISKUS versus Albuterol Aerosol 200mcg (180 mcg Ex-Actuator) versus Placebo in Paediatric Subjects Aged 4-11 years with Asthma. Study period: 20 Jan 1997 - 06 Sep 1997. GSK Study Report Number: Report Nos. RM1997/00754/00. Methods • Objective To compare the safety and efficacy of albuterol powder 200 mcg QID via DISKUS versus albuterol aerosol 200 mcg QID (180 mcg ex/actuator) via the MDI versus placebo QID over a 4-week treatment period in paediatric subjects age 4-11 years with asthma. Thus, the purpose of this study was to determine the safety and efficacy of albuterol powder 200 mcg via the DISKUS over a 4-week treatment period in paediatric patients aged 4-11. • Study design Salbutamol Final Public Assessment Report RO/W/0001/pdWS/001 Page 11/76
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: Neonatal onset of symptoms (associa
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 and 38: Three studies regarding the clinica
Page 39 and 40: The improvment in PEF was 51 L. min
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
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Question 3 In case of divergences b
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United Kingdom: Salbulin MDPI Novol
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2. Completely depress the coloured
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The harmonised SmPC as outcome of t
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Assessment of the Applicant’s res
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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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