Public Assessment Report for paediatric studies submitted in ...

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endocrine disorders, hepatic and renal disease, glaucoma, respiratory infection within two weeks prior to screening, and a history of immediate or delayed hypersensitivity reaction to any sympathomimetic drug or corticosteroid therapy � Had used methotrexate, gold, cyclosporine, and other immunosuppressive agents � Presented with a fever (defined as a rectal temperature ≥100.5°F (38°C). � Born prior to 34 weeks of gestation and/or had an episode of mechanical ventilation � Had clinically significant abnormalities of clinical laboratory tests at screening � Had received an investigational drug for any indication within 30 days of screening or within 10 half-lives (whichever was the longer of the two) The primary objective of this study was to evaluate the safety and efficacy of cumulative dose administration of VENTOLIN HFA 180mcg and 360mcg both in propellant 1, 1, 1, 2-tetrafluoroethane (GlaxoSmithKline code GR106642X) MDI inhalation aerosol delivered with a valved holding chamber (AeroChamber Plus) with attached facemask in an acute care clinical setting. Subjects were between the ages of birth to
Protocol deviations were summarised by each treatment group and haven’t had a significant impact on the safety or integrity of the study results. Criteria for evaluation: Primary efficacy variable The mean percent change from baseline over the entire treatment period in the Modified Tal Asthma Symptom Score assessed by the investigator. Secondary efficacy variable including The change from baseline over the entire treatment period in absolute Modified Tal Asthma Symptoms Score, and rescue salbutamol use. groups. Safety variable including assessment of: � Continuous ECG monitoring � Adverse events � Pulse oximetry � Vital signs � Physical examination � Clinical laboratory tests for blood glucose and serum potassium, � Symptom of adrenergic stimulation. Statistical methods and determination of sample size: All statistical tests performed tested two-sided hypotheses of no difference between treatment The nominal significance level was 0.05. Analysis of Modified Tal Asthma Symptom Score data was performed using analysis of covariance (ANCOVA) adjusting for baseline Modified Tal Asthma Symptoms Score, investigative site, age, and gender. All programming was performed using SAS version 8, in a UNIX environment. The sample size of 30 subjects per treatment group would provide at least 90% power to detect a difference of 23% between the two treatment groups in mean percent change from baseline in Modified Tal Asthma Symptom Score over the entire 3-hour treatment period Analysis sets: Intent-to-Treat (ITT) Population - all subjects who were randomized and received at least one dose of study medication. Analyses of all safety and efficacy data were based on this population (n=87) Fulfilled Regulatory Criteria (FRC) Population - subjects in the ITT Population who also received a minimum of 3 study treatment doses and provided Holter monitoring data, was a supporting population used for analysis of safety and efficacy data (n=66) The subset of the ITT Population, the Fulfilled Regulatory Criteria (FRC) population was evaluated based on the FDA Written Request and this population included subjects that required a minimum of three study treatment dosings during the treatment period. Assessor's comment: In general, the efficacy of bronhodilatator therapy in infants is often difficult demonstrated. According to CHPM/EWP/4151/00, Rev 1 “in children 5 years of age and younger, spirometry is feasible in children over 3 years, although either FEV0.5 or FEV0.75 may be a better measure than FEV1 ( literature should Salbutamol Final Public Assessment Report RO/W/0001/pdWS/001 Page 33/76
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: This study demonstrated similar saf
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
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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