Public Assessment Report for paediatric studies submitted in ...

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A total of 118 male and female subjects between the ages of birth to 81%). Twenty-two subjects below 1 year of age were included. Inclusion criteria: � Outpatient in an acute care setting. � Birth to 23 months old at visit 2) � Male or female � documented history of asthma symptoms � Subjects had least 1 episodes of increased symptoms of asthma requiring medical attention and asthma pharmacotherapy within the preceding 12 months prior to Visit 1 � Subjects had received a maintenance asthma medication other than systemic corticosteroids on a regular basis for the preceding 4 weeks � Subjects received treatment with a short-acting beta-agonist for the relief of asthma symptoms at least three times per week over the preceding 4 weeks prior to visit 1. � Subjects and parents/guardians had to have demonstrated the ability to comply with the use of the MDI and the holding chamber with facemask using the demonstration kit provided to the site. The primary objective of this study was to evaluate the safety and efficacy of VENTOLIN HFA MDI 90mcg and 180mcg TID delivered with facemask and a holding chamber versus HFA placebo supplemented with the use of rescue VENTOLIN HFA or albuterol nebules over a 4 week (minimum 29 days) treatment period in subjects between the ages of birth to
In the ITT population the daytime asthma symptom scores were similar across the treatment groups at baseline. At endpoint, the daytime asthma symptoms were also similar across treatment groups. At Baseline, the percentage of symptom-free 24-hour days was greater for the placebo (16.3) group and VENTOLIN HFA 180mcg group (14.7) than for the VENTOLIN HFA 90mcg (9.0) treated group. The mean change over the four week treatment period, the evaluation at endpoint in the percent of symptom-free 24 hour days, was similar. When the weekly percentage of symptom-free 24 hour days was analyzed over the four weeks of treatment, subjects in all three groups demonstrated that the percentage of symptom free days increased. Other efficacy endpoints At baseline, 24-hour rescue albuterol use was comparable across the treatment groups except for a slightly lower use in the VENTOLIN HFA 180mcg group. At endpoint, subjects in the VENTOLIN HFA 90 mcg group experienced a slightly greater mean reduction in 24-hour albuterol use. The maximum decrease in 24 hour rescue albuterol use was between –1.5 and –1.8 puffs at week 1 with the greatest decrease in the VENTOLIN HFA 90mcg group. The mean time to asthma exacerbation for the active group was approximately 5-8 days greater than that for the placebo group. The subjects in the placebo group had an exacerbation ranging between the first week and 41 days post treatment of investigational product administration. In the VENTOLIN HFA 90mcg group, one subject reported an exacerbation more than once and was withdrawn. Another subject from the same group reported an exacerbation after 24 days of treatment that resolved. In the VENTOLIN HFA 180 mcg group 3 subjects reported an exacerbation between 17-28 days during the treatment period and one reported an exacerbation at 36 days during the post treatment period. The primary cause of these asthma exacerbations were either respiratory infections or infections due to unknown etiology. In the ITT population, night time asthma symptom scores were similar across the treatment groups at baseline. At endpoint, subjects in all three groups had similar night time symptom scores. The percentage of nights with no awakenings due to asthma for subjects in the VENTOLIN 90mcg group at baseline were slightly lower than the other two groups. Both the VENTOLIN HFA 180mcg and placebo treated groups experienced a similar change from baseline to endpoint (the average of the 4-week treatment period) in percentage of nights with no awakenings due to asthma which was lower than the change from baseline to endpoint in the VENTOLIN HFA 90mcg group Safety results Adverse events A total of 59 subjects (53%) reported at least one AE during treatment: 20 subjects (71%) in the placebo group, 17 subjects (59%) in the VENTOLIN HFA 90mcg group, and 22 subjects (76%) in the VENTOLIN HFA 180mcg group. The most frequently reported event was pyrexia which was higher in the VENTOLIN HFA 180mcg group (7 subjects) than the VENTOLIN HFA 90mcg (2 subjects) and placebo (3 subjects). The next frequently reported adverse events were nasopharyngitis (3 subjects in the placebo group, and 2 and 4 subjects respectively in the Ventolin 90 and 180mcg groups), upper respiratory tract infection (5 subjects in the VENTOLIN HFA 180mcg group and 3 in the placebo group), sinus tachycardia (5 subjects in the VENTOLIN HFA 180mcg group and 2 subjects each in the VENTOLIN HFA 90mcg and placebo groups), nasopharyngitis (3 subjects in the placebo group and 2 and 4 subjects in the VENTOLIN HFA 90 and 180mcg groups respectively), teething (3 subjects in the placebo, 4 in the VENTOLIN HFA 90mcg and 1 subject in the VENTOLIN HFA 180mcg group), rhinorrhoea (3 subjects in the placebo and 2 Salbutamol Final Public Assessment Report RO/W/0001/pdWS/001 Page 29/76
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: At Week 4, mean changes from baseli
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
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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