TY - JOUR

T1 - Effect of asthma compliance enhancement training on asthma control in patients on combination therapy with salmeterol/fluticasone propionate: a randomised controlled trial

AU - Ulrik, Charlotte Suppli

AU - Claudius, Birgitte Kjor

AU - Tamm, Michael

AU - Harving, Henrik

AU - Siersted, Hans Christian

AU - Backer, Vibeke

AU - Hellquist, Birthe

AU - Dahl, Ronald

AU - Høgholm, Asbjørn

AU - Jøhnk, Ida Karina

N1 - Times Cited: 1ArticleEnglishUlrik, C. SVirum Overdrevsvej 13, DK-2830 Virum, DenmarkCited References Count: 22456TPWILEY-BLACKWELL PUBLISHING, INCCOMMERCE PLACE, 350 MAIN ST, MALDEN 02148, MA USAMALDEN

PY - 2009/7/1

Y1 - 2009/7/1

N2 - OBJECTIVE: We investigated if a higher proportion of adults with previously uncontrolled asthma can achieve total control when given salmeterol/fluticasone propionate (50/250 microg) bid and compliance enhancement training (CET) compared to those given medication alone. METHODS: Open comparison of stable, but uncontrolled, adult asthmatics. After a 12-week treatment period on salmeterol/fluticasone propionate (period 1), patients who failed to achieve control were randomised to continuing treatment with or without CET for 12 weeks (period 2). The primary end point was the proportion achieving total control of their asthma in 7 of the last 8 consecutive weeks of period 2. RESULTS: A total of 361 subjects (50.4% males, mean age 40.0 +/- 14.4 years) in 29 centres were included, of whom 75.9% were randomised into treatment period 2 (n = 140 in the intervention group). The proportion of subjects achieving total asthma control was 8.8% and 7.6%, respectively, in the intervention and control group [not significant (NS)]. Mean morning peak flow, forced expiratory volume in one second (FEV(1)), asthma symptom score and quality of life improved significantly over the study period in both treatment groups. Furthermore, proportion of days with use of rescue medication declined from 59.7% +/- 34.6% (55.7% +/- 35.3%) during screening to 20.3% +/- 29.2% (19.4% +/- 30.9%) during treatment period 2 (NS). CONCLUSION: CET failed to increase the likelihood of achieving total control in asthmatics on salmeterol/fluticasone propionate compared to subjects receiving medication only. However, both groups had a significant improvement in asthma control. (Clinical Trials.gov number, NCT00351143)

AB - OBJECTIVE: We investigated if a higher proportion of adults with previously uncontrolled asthma can achieve total control when given salmeterol/fluticasone propionate (50/250 microg) bid and compliance enhancement training (CET) compared to those given medication alone. METHODS: Open comparison of stable, but uncontrolled, adult asthmatics. After a 12-week treatment period on salmeterol/fluticasone propionate (period 1), patients who failed to achieve control were randomised to continuing treatment with or without CET for 12 weeks (period 2). The primary end point was the proportion achieving total control of their asthma in 7 of the last 8 consecutive weeks of period 2. RESULTS: A total of 361 subjects (50.4% males, mean age 40.0 +/- 14.4 years) in 29 centres were included, of whom 75.9% were randomised into treatment period 2 (n = 140 in the intervention group). The proportion of subjects achieving total asthma control was 8.8% and 7.6%, respectively, in the intervention and control group [not significant (NS)]. Mean morning peak flow, forced expiratory volume in one second (FEV(1)), asthma symptom score and quality of life improved significantly over the study period in both treatment groups. Furthermore, proportion of days with use of rescue medication declined from 59.7% +/- 34.6% (55.7% +/- 35.3%) during screening to 20.3% +/- 29.2% (19.4% +/- 30.9%) during treatment period 2 (NS). CONCLUSION: CET failed to increase the likelihood of achieving total control in asthmatics on salmeterol/fluticasone propionate compared to subjects receiving medication only. However, both groups had a significant improvement in asthma control. (Clinical Trials.gov number, NCT00351143)

U2 - 10.1111/j.1752-699X.2009.00129.x

DO - 10.1111/j.1752-699X.2009.00129.x

M3 - Journal article

C2 - 20298399

VL - 3

SP - 161

EP - 168

JO - Clinical Respiratory Journal

JF - Clinical Respiratory Journal

SN - 1752-6981

IS - 3

ER -