SYNOPSIS. The study results and synopsis are supplied for informational purposes only.

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1 SYNOPSIS INN : CROMOGLICIC ACID Study number : (AAR-DE-301) Study title : A multicenter, double-blind, randomized group comparison study with two parallel groups over 12 weeks in children and adolescents with asthma to investigate the safety and tolerability of Aarane / Allergospasmin containing an alternative propellant (HFA 227) by comparison with the current commercial product containing CFC propellant gas CSR date : November 19, 2001 The study results and synopsis are supplied for informational purposes only. Not all of the study results have necessarily been reviewed by the Regulatory Authorities. The decision to prescribe and take a product should always be made on the basis of the most recent version of the product information and product package insert in the country of prescription. PDF name: Cromoglicic Acid-Study 1 EMA request May 2011 Publication of result-related information on paediatric studies submitted under Article 45 of Regulation (EC) No 1901/2006 ( Paediatric Regulation ) August 2011

2 Safety and Tolerability of DSCG and Reproterol with Propellant Gas containing HFA 227 in Children Page 3 of 33 STUDY SYNOPSIS Study identification code Title Investigators Study duration Study objective Study design Study schedule (AAR-DE-301) A multicenter, double-blind, randomized group comparison study with two parallel groups over 12 weeks in children and adolescents with asthma to investigate the safety and tolerability of Aarane / Allergospasmin containing an alternative propellant (HFA 227) by comparison with the current commercial product containing CFC propellant gas Multicentre study conducted at 14 sites in Germany: Dr. Behre, Kehl Dr. Berzel, Mannheim Dr. Freund, Cologne Dr. Generlich, Berlin Dr. Geisz, Wetzlar Dr. Kaecke, Berlin Dr. Lässig, Halle Dr. Rabe, Treuenbrietzen Dr. Seidel, Gera Dr. Silbermann, Berlin Dr. Soemantrie, Kleve Dr. Stapper, Cologne Dr. Steinhauer, Krefeld Dr. von Berg, Wesel (also LKP for the study) The study started on February 8, 1999 (first patient in) and ended on December 13, 1999 (last patient out). A study in children and adolescents with asthma to investigate the safety and tolerability of the fixed drug combination of DSCG and reproterol hydrochloride (AARANE / ALLERGOSPASMIN ) containing an alternative propellant (HFA 227) by comparison with the same combination containing CFC propellant gas. Multicenter, randomized, double-blind, parallel-group comparison lasting 12 weeks. After informed consent had been obtained, eligible children were enrolled in the 12-week double-blind phase and were randomly assigned to one of the two treatments. Visits to the study center were scheduled at the beginning and end of the 12-week period and at 4-weekly intervals. At each visit, vital signs (heart rate, blood pressure) and pulmonary function (MEF 25 75%, FEV 1, FVC) were monitored 5 minutes before and 5 and 15 minutes after inhalation of the assigned study aerosol, and a severity score for respiratory disease (cough, dyspnea, expectoration) was determined by the investigator. Tolerability was assessed by the investigator at the end of the doubleblind phase. The children were required to keep a diary each day for the entire period of their participation in the study. Routine laboratory investigations were not scheduled.

3 Safety and Tolerability of DSCG and Reproterol with Propellant Gas containing HFA 227 in Children Page 4 of 33 Primary variable Secondary variables Assessment of safety and tolerability Statistical methods Results: Efficacy Results: Tolerability Incidence rate of patients with adverse drug reactions (ADRs). Investigator s global assessment of tolerability. Documentation of occurrence of paradoxical bronchospasm by recording FEV 1 at 5 and 15 minutes after inhalation. Pulmonary function (MEF 25 75%, FEV 1, FVC) at each visit to the study centre. PEFR (patient diary). Vital signs (blood pressure, heart rate). Symptoms (cough, expectoration, dyspnea) using an assessment score (diary and visits). Safety and tolerability were assessed by documenting all adverse events that occurred during the course of the study, and in terms of a final global assessment of tolerability by the investigator at the end of the 12-week treatment phase. The occurrence of paradoxical bronchospasm was also used for the assessment: this was documented by a reduction in FEV 1 of at least 10% at max. 15 minutes after inhalation from the study aerosol. Randomization was performed in blocks of 4. Complete blocks were allocated to each study center. The study was conducted according to an adaptive design with a maximum of two interim analyses. The significance level for the study was set at α = (one-sided). Tests were performed to establish the non-inferiority of the formulation containing HFA 227 with regard to the primary variable. Adjustment of the α-level for the interim analyses was performed using Pocock s group sequential design (12). With a type 2 error risk of β = 0.4 for the first interim analysis, the planning criteria yielded a statistically necessary sample size of N = 107 for each treatment group (normal distribution approximation). 120 children were randomized to each group. The significance level for the first interim analysis was α 1 = The biometric analysis was performed by ClinResearch GmbH, Cologne. With regard to the efficacy variables (pulmonary function, asthma symptoms) it was confirmed that the fixed drug combination of DSCG and reproterol with the novel propellant containing HFA 227 was equivalent in terms of efficacy in the treatment of asthma with the combination product containing the conventional CFC propellant. There was no difference between the two combinations in terms of any of the variables used for the efficacy assessment. For statistical analysis the incidence rate of adverse drug reactions (ADRs) was used. This required a causality assessment to be made for every adverse event. ADRs were defined as all adverse events for which the investigator was unable to exclude a causal relationship with the study medication, i.e. the investigator was unable to state that there was definitely no causal relationship.

4 Safety and Tolerability of DSCG and Reproterol with Propellant Gas containing HFA 227 in Children Page 5 of 33 Results: Tolerability (cont d) In total, 32 children complained of ADRs: 15 children (12.9%) in the Aarane HFA 227 group, and 17 children (14.9%) in the Aarane CFC group. The causal relationship was assessed by the investigator as unlikely in 26 children (12 Aarane HFA 227 vs. 14 Aarane CFC), as possible in 5 children (3 Aarane HFA 227 vs. 2 Aarane CFC), and as probable in 2 children (2 Aarane HFA 227 vs. 0 Aarane CFC). From the data on 230 patients made available for this first interim analysis, it was found that the assumptions made in the sample size calculation were inapplicable for this study. On the basis of data (11) available for a very small number of children, it was assumed that the incidence of ADRs with the formulation containing CFC is 8% and the incidence of ADRs with the formulation containing HFA 227 is 2%. Two percentage points were to be accepted as the equivalence range for the demonstration of non-inferiority. After unblinding it was found that the incidence rate for ADRs in the Aarane HFA 227 group was slightly lower than in the Aarane CFC group. However, the confirmatory objective was not achieved with this interim analysis. The resultant confidence interval does not lie completely within the one-sided equivalence range of +2. Since the assumptions concerning the incidence rates for both treatments were clearly erroneous, and since a considerably larger number of patients than planned (1565 per treatment arm) would have been necessary to demonstrate the non-inferiority of the new formulation containing HFA 227 by comparison with the formulation of AARANE /ALLERGOSPASMIN containing CFC, the study was terminated at the instigation of the Sponsor with the non-rejection of the null hypothesis. A further main outcome criterion was the occurrence of paradoxical bronchospasm, measured in terms of FEV 1 at 5 and 15 minutes after inhalation. Paradoxical bronchospasm was defined as a documented minimum 10% reduction in FEV 1. In total, irrespective of visit and time of documentation, 48 paradoxical bronchospasms occurred in 30 patients (13%). The number of instances in the group receiving Aarane HFA observed instances in 17 patients (14.7%) was slightly higher than in the group receiving Aarane CFC with 22 observed instances in 13 patients (11.4%). The investigator s global assessment of tolerability at the end of the study for each patient after 12 weeks of treatment at Visit 4 was considered as a third main outcome criterion. The investigators assessed the tolerability of the study medication using the criteria very good/good, satisfactory, poor and could not be assessed. Tolerability was not graded as poor or could not be assessed in any of the children. Tolerability was very good/good in 212 children and satisfactory in 11 children; details of the tolerability assessment were lacking in 7 children. Tolerability was assessed as being marginally better in the children treated with Aarane HFA 227 ( very good/good in 110 children, satisfactory in 3 children) than in the group treated with Aarane CCF ( very good/good in 102 children, satisfactory in 8 children).

5 Safety and Tolerability of DSCG and Reproterol with Propellant Gas containing HFA 227 in Children Page 6 of 33 Summary The objective of the study was to demonstrate that the tolerability and safety of the new metered-dose aerosol of AARANE / ALLERGOSPASMIN containing HFA 227 (1 spray dose contains 1 mg disodium cromoglycate and 0.5 mg reproterol hydrochloride) are equivalent to those of a metered-dose aerosol containing CFC in the treatment of children. The primary objective was to demonstrate the non-inferiority of the new formulation containing HFA 227 in comparison with the formulation of AARANE /ALLERGOSPASMIN containing CFC in terms of the incidence of adverse events where the investigators were unable to exclude a causal relationship with the study medication (= ADRs). In terms of safety and efficacy in the treatment of asthma, the fixed drug combination of DSCG and reproterol with the new propellant containing HFA 227 was equivalent to the combination product with the conventional propellant containing CFC. There was no difference between the two combinations in terms of any of the variables studied for the assessment of tolerability and efficacy. However, the confirmatory objective was not achieved with this interim analysis. The resultant confidence interval does not lie completely within the one-sided equivalence range of +2% points. Since a considerably larger number of patients than planned would have been necessary to demonstrate the non-inferiority of the new formulation containing HFA 227 by comparison with the formulation of AARANE /ALLERGOSPASMIN containing CFC, the study was terminated at the instigation of the Sponsor with the non-rejection of the null hypothesis (negative study result).

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