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5 August 2004 Version The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product. Before prescribing any product mentioned in this Register, healthcare professionals should consult prescribing information for the product approved in their country. Study No.: SAM 30020 Title: Efficacy and tolerability of the salmeterol/fluticasone 50/100 mcg combination Diskus, inhaled once daily in the evening, in comparison to the p.r.n. inhalation from the reproterol/sodium cromoglycate 0.5/ 1 mg combination MDI, as initial therapy for patients with mild asthma – a multicentre, randomised, open, parallel trial Rationale: The reproterol/sodium cromoglycate 0.5/ 1 mg combination is still widely used for the treatment of mild asthmatics. Usually, patients inhale the combination product from an MDI, and they adjust the dosage according to their asthma symptoms. Anti-inflammatory medication with an inhaled corticosteroid such as fluticasone is an alternative therapeutic option, and long-acting beta agonists can be used as bronchodilatory treatment. The study aimed to investigate whether the efficacy of the salmeterol/fluticasone 50/100-mcg combination (SFC), inhaled from the Diskus once daily in the evening, is superior to that of the PRN inhalation of the reproterol/sodium cromoglycate 0.5/ 1 mg combination (RS) from the metered dose inhaler. Phase: IV Study Period: 13 June 2002 to 27 June 2003 Study Design: This randomised, prospective, open, parallel group study had a total duration of ten weeks. There were two study periods: a run-in period of two weeks, and a treatment period of 8 weeks. Subjects visited the study centre at the start of run-in, end of the 2 week run-in and randomisation period, after four weeks of treatment, and after eight weeks of treatment. Centres: 25 centres in Germany Indication: Mild allergic asthma Treatment: Subjects in the SFC group inhaled from the salmeterol/fluticasone 50/100 mcg combination Diskus once daily in the evening. Subjects in the RS group inhaled from the RS combination metered dose inhaler: The initial dose was 2 puffs four times daily. Subjects were allowed to adjust (increase or decrease) the dose depending on the extent of asthma symptoms up to a maximum daily dose of 2 puffs eight times daily. Objectives: To investigate in subjects with mild asthma whether the efficacy of the salmeterol/fluticasone 50/100 mcg combination, inhaled from the Diskus once daily in the evening, is superior to that of the PRN inhalation of the reproterol/sodium cromoglycate 0.5/ 1 mg combination from the metered dose inhaler. Primary Outcome/Efficacy Variable: Change in Diary Record Card mean morning peak expiratory flow rate (l/min) during weeks 5 to 8 compared to base- line Secondary Outcome/Efficacy Variable(s): Changes of the following parameters at weeks 4 and 8 compared to base-line (= at visit 2 or during the 7 days preceding visit 2): Mean morning peak expiratory flow rate (PEFR, l/min) Mean evening PEFR (l/min) Forced expiratory volume in one second (FEV1, L and as % predicted) Mean asthma symptom scores (day and night) Proportion of days without use of rescue medication Proportion of days without symptoms Adverse events Number and severity of asthma exacerbations. Statistical Methods: The primary efficacy population was the intention-to-treat group. The mean values for the primary end-point were calculated from all available and reliable morning PEFR data obtained during the seven days preceding visit 2 (base- line) and during weeks 5 to 8 (end of study). Statistical methods were analysis of covariance (GLM procedure) and descriptive statistics with 95% confidence intervals of the means. The safety population consisted of all subjects who had been taken study drug. The intention-to-treat group consisted of n=207 subjects, the per-protocol group of n=162 participants. 1 Study Population: Inclusion criteria at the screening visit: Mild allergic asthma, FEV1 > 60% of the predicted normal value, FEV1 reversibility of at least 12% compared to baseline after the inhalation of 400 mcg salbutamol Inclusion criteria for randomisation: During the last seven days of the run-in period, the subjects had EITHER an asthma symptom score (day and night) of at least 2 AND/OR he/she had inhaled salbutamol at least once per day within a 3 to 6 day period. Major exclusion criteria at screen: During the 12 weeks preceding the screening visit, the subject had been treated with inhaled, oral, parenteral or depot corticosteroids, anti-leukotrienes, inhaled long acting or oral beta agonists, or oral slow-release theophylline. Exclusion criterion at randomisation: During the last seven days of the run-in phase, the subject had experienced asthma symptoms on each day, or he/she had used salbutamol on each day SFC RS Number of Subjects: (ITT) 105 102 Planned, N 87 87 Randomised, N 105 102 Completed, n (%) 100 92 Total Number Subjects Withdrawn, N (%) 5 10 Withdrawn due to Adverse Events n (%) 2 (2%) 5 (5%) Withdrawn due to Lack of Efficacy n (%) 0 0 Withdrawn for other reasons n (%) 3 (3%) 5 (5%) Demographics SFC RS N (ITT) 105 102 Females: Males 47:58 39:63 Mean Age, years (SD) 44.7 (16.3) 42.4 (17.1) Race, n (%) Unknown unknown Primary Efficacy Results: SFC RS Mean baseline morning PEFR (L/min) (sd) 357 (114) 353 (128) Raw mean change (sd) in morning PEFR (L/min) during weeks 5-8 compared to base-line for ITT Group (LOCF) 26.8 (37.9) 12.3 (45.2) Difference between treatments in morning PEFR 14.5 95% Confidence Interval ITT Group 3.1 to 26.0 P value 0.013 Secondary Efficacy Results: Raw mean changes (sd) compared Treatment 95% CI to baseline of the following SFC RS Difference . parameters: SFC - RS Evening PEFR (L/min) weeks 5-8 24.9 (35.9) 13.2 (45.4) 11.2 0.2 to 22.6 FEV1 (L) at week 8 (L) 0.26 (0.44) 0.10 (0.56) 0.16 0.02 to 0.30 (% predicted) 8.9 (17.1) 3.7 (18.8) 5.8 0.8 to 10.9 Symptom score weeks 5-8 morning -0.32 (0.46) -0.11 (0.52) 0.19 0.07 to 0.31 evening -0.38 (0.47) 0.03 (0.65) 0.39 0.24 to 0.54 FVC (L) at week 8 (L) 0.16 (0.65) 0.17 (0.61) 0.01 -0.15 to 0.18 (% predicted) 5.4 (23.1) 4.2 (17.9) 1.80 -4.0 to 7.6 Safety Results: SFC RS Most Frequent Adverse Events – On-Therapy Subjects with any AE(s), n(%) 17 (16.2) 18 (17.5) 2 Asthma 3 (2.8) 4(3.9) Influenza-like symptoms 3(2.8) 3(2.9) Musculoskeletal disorder 1(0.9) 3(2.9) Pharyngitis 2(1.9) 3(2.9) Bronchitis 0 3(2.9) Cough 1 (0.9%) 0 Rhinitis 1 (0.9%) 0 Nausea 1 (0.9%) 0 Torticollis 0 1 (0.9%) Hypertension 0 1 (0.9%) URTI 0 1 (0.9%) Serious Adverse Events - On-Therapy n (%) [n considered by the investigator to be related to study medication] SFC RS Subjects with non-fatal SAEs, n (%) 0 2 (1.9) [0] Asthma 0 1 (0.9) [0] Myocardial infarction 0 1 (0.9) [0] Subjects with fatal SAEs, n (%) 0 0 Conclusion: See publication below. Publication: Schmidtmann S, Malek R, Trautmann M, for the SAM 30020-Study group. Die 1x tägliche Inhalation aus dem Salmeterol-Fluticason (50/100µg) Diskus® bei leichtem Asthma – eine randomisierte Studie im Vergleich zur bedarfsweisen Inhalation der Reproterol-DNCG-Kombination (Poster 184). Pneumologie 59: S1, 2005 Date Updated: 20-Sep-2005 3 .
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