Last updated: 11/07/2018 18:39:30

A Multicentre, stratified, randomised, double-blind, parallel-group, step-up comparison of the level of asthma control achieved with salmeterol/fluticasone propionate combination diskus (Accuhaler) dry powder inhaler compared with fluticasone propionate Diskus alone in adults and adolescents.

GSK study ID
SAM40027
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Multicentre, stratified, randomised, double-blind, parallel-group, step-up comparison of the level of asthma control achieved with salmeterol/fluticasone propionate combination diskus (Accuhaler) dry powder inhaler compared with fluticasone propionate Diskus alone in adults and adolescents.
Trial description: A Multicentre, stratified, randomised, double-blind, parallel-group, step-up comparison of the level of asthma control achieved with salmeterol/fluticasone propionate combination diskus (Accuhaler) dry powder inhaler compared with fluticasone propionate Diskus alone in adults and adolescents.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Abstract: Achieving and maintaining guideline defined asthma control with salmeterol/ fluticasone propionate versus fluticasone propionate alone: the results of the goal study. E. Bateman, H. Bousheyl J. Bousquet W. Busse T. Clarkl R. Pauwels S. Pedersen. 100th International Conference of the American Thoracic Society 5/21/2004 Orlando FL
Abstract: Achieving asthma control with fluticasone propionate/salmeterol (fsc; advairâ®/seretideâ®). Bateman, E. MD, Atienza, T. MD, Mihaescu, T. MD, Duggan, M. BSc, Jacques, L. PhD, and Goldfrad, C. MSc 101st International Conference of the American Thoracic Society 5/20/2005 San Diego, CA; USA
Abstract: Achieving gina/nih guideline-based asthma control with salmeterol/fluticasone compared with fluticasone alone: the results of the goal study. Busse, Bateman, H. Bousheyl J. Bousquet W. Busse T. Clarkl R. Pauwels S. Pedersen., S. 7 60th Annual Meeting of the American Academy of Allergy, Asthma and Immunology 3/19/2004 San Francisco, CA; USA
Abstract: Achieving gina/nih guideline-based asthma control with salmeterol/fluticasone compared with fluticasone alone: the results of the goal study. Busse, W. W. 1, Bateman, E. 2, Boushey, H. 3, Bousquet, J. 4, Clark, T. 5, Pauwels, R. 6, and Pedersen, S. 7 60th Anniversary Meeting of the American Academy of Allergy, Asthma and Immunology 3/7/2003 Denver, CO; USA
Abstract: Achieving total control of asthma with salmeterol/fluticasone propionate versus fluticasone propionate alone: goal study results. Homer Bousheyl, Eric Bateman Jean Bousquet William Busse4 Tim Clark, Romain Pauwels Soren Pedersen 4th Triennial World Asthma Meeting 2/16/2004 Bangkok Thailand
Abstract: Addition of oral corticosteroids to combination therapy has little impact on achieving total control of asthma. Romain Pauwels, Eric Bateman, Homer Bousheyl ,Jean Bousquet, William Busse, Tim Clark, Soren Pedersen. 4th Triennial World Asthma Meeting 2/16/2004 Bangkok Thailand
Abstract: Aiming for guideline defined total control of asthma improves one-year asthma outcomes: results of the goal study. Soren Pedersen, Eric Bateman Homer Bousheyl, Jean Bousquet, William Busse, Tim Clark, Romain Pauweisl. 4th Triennial World Asthma Meeting 2/16/2004 Bangkok Thailand
Abstract: Aiming for total control in asthma: an ineffective use of resources? Andreasson, Emma and Naya, Ian 15th Annual Congress of the European Respiratory Society 9/17/2005 Copenhagen; Denmark
Abstract: Aiming for total control of asthma in patients taking inhaled corticosteroids improves traditional outcomes: results of the gaining optimal asthma control (goal) study. S E Pederseni, E D Bateman on behalf of the GOAL Steering Committee 23rd Congress of the European Academy of Allergology and Clinical Immunology (EAACI) 6/12/2004 Amsterdam Netherlands
Abstract: Aiming for total control of asthma with salmeterol/fluticasone propionate (sfc), a cost effective option. Bousquet J. , Bateman E., Briggs A., Clark T., Pedersen S., and Busse W. 15th Annual Congress of the European Respiratory Society 9/17/2005 Copenhagen; Denmark
Abstract: Aiming to achieve total control with salmeterol/fluticasone propionate and fluticasone propionate alone is well tolerated: goal 1-year safety data. William Busse, Eric Bateman Homer Bousheyl Jean Bousquet Tim Clarkl Romain Pauwe, Seiren Pedersen. 4th Triennial World Asthma Meeting 2/16/2004 Bangkok Thailand
Abstract: Asthma control is maintained if treatment with fluticasone propionate/salmeterol (fsc; advairâ®/seretideâ®) is stepped down. Bateman, E. MD, Atienza, T. MD, Mihaescu, T. MD, Duggan, M. BSc, Jacques, L. PhD, and Goldfrad, C. MSc 101st International Conference of the American Thoracic Society 5/20/2005 San Diego, CA; USA
Abstract: Can total control of asthma be achieved? the results of the goal study. Pauwels R., Bateman E., Boushey H. , Bousquet J. , Busse W. , Clark , and Pedersen S. 60th Annual Meeting of the American Academy of Allergy, Asthma and Immunology 3/19/2004 San Francisco, CA; USA
Abstract: Can total control of asthma be achieved? the results of the goal study. Pauwels, R. 1, Bateman, E. 2, Boushey, H. 3, Bousquet, J. 4, Busse, W. 5, Clark, T. 6, and Pedersen, S. 7 60th Anniversary Meeting of the American Academy of Allergy, Asthma and Immunology 3/7/2003 Denver, CO; USA
Abstract: Goal (gaining optimal asthma control): a study to assess asthma control. Clark, T. J., Bousquet, J., Bateman, E. D., and James, M. H. 11th Annual Congress of the European Respiratory Society 9/22/2001 Berlin; Germany
Abstract: Improved exacerbation rates and asthma control in current and former smokers treated with salmeterol/fluticasone propionate: results of the goal study. Boushey H. A., Pedersen S., Bateman E., Clark T., Busse W. , Bousquet J., and Pauwels R. 61st Annual Meeting of the American Academy of Allergy, Asthma and Immunology 3/18/2005 San Antonio, TX; USA
Abstract: Improvements in asthma outcomes following 1 year of treatment with salmeterol/fluticasone or fluticasone alone when stepped up to achieve guideline-defined total control. Boushey, H. 1, Bateman, E. 2, Bousquet, J. 3, Busse, W. 4, Clark, T. 5, Pauwels, R. 6, and Pedersen, S. 7 60th Anniversary Meeting of the American Academy of Allergy, Asthma and Immunology 3/7/2003 Denver, CO; USA
Abstract: Improvements in asthma outcomes following 1 year of treatment with salmeterol/fluticasone or fluticasone alone when stepped up to achieve guideline-defined total control. Busse, Bateman, H. Bousheyl J. Bousquet W. Busse T. Clarkl R. Pauwels S. Pedersen., S. 7 60th Annual Meeting of the American Academy of Allergy, Asthma and Immunology 3/19/2004 San Francisco, CA; USA
Abstract: Salmeterol/fluticasone and fluticasone alone are well tolerated over 1 year of treatment stepped-up to achieve total control: safety results of the goal study. Busse, Bateman, H. Bousheyl J. Bousquet W. Busse T. Clark, Pauwels S. Pedersen., S. 7 60th Annual Meeting of the American Academy of Allergy, Asthma and Immunology 3/19/2004 San Francisco, CA; USA
Abstract: Salmeterol/fluticasone and fluticasone alone are well tolerated over 1 year of treatment stepped-up to achieve total control: safety results of the goal study. Clark, T. 1, Bateman, E. 2, Boushey, H. 3, Bousquet, J. 4, Busse, W. 5, Pauwels, R. 6, and Pedersen, S. 7 60th Anniversary Meeting of the American Academy of Allergy, Asthma and Immunology 3/7/2003 Denver, CO; USA
Abstract: The effect of oral corticosteroids and high-dose combination therapy on achieving control of refractory asthma. Bousquet, J. 1, Bateman, E. 2, Boushey, H. 3, Busse, W. 4, Clark, T. 5, Pauwels, R. 6, and Pedersen, S. 7 60th Anniversary Meeting of the American Academy of Allergy, Asthma and Immunology 3/7/2003 Denver, CO; USA
Abstract: Time course of achievement of individual clinical goals of asthma treatment: the results of the goal study. T. Clarkl, E. Bateman2 H. Bousheyl J. Bousquet W. Busse R. Pauwels S. 100th International Conference of the American Thoracic Society 5/21/2004 Orlando FL
Abstract: aiming for total control of asthma reduces the risk of exacerbations: a comparison of salmeterol/fluticasone propionate vs fluticasone propionate alone. R, Pauwe. E. Bateman, H. Bousheyl J. Bousquet W. Busse T. Clarkl R. Pauwels S. Pedersen. 100th International Conference of the American Thoracic Society 5/21/2004 Orlando FL
Abstract: aiming for total control of asthma significantly improves asthma-related quality of life: salmeterol/fluticasone propionate versus fluticasone propionate alone. E. Bateman, H. Bousheyl J. Bousquet W. Busse T. Clarkl R. Pauwels S. Pedersen. 100th International Conference of the American Thoracic Society 5/21/2004 Orlando FL
Abstract: the effect of oral corticosteroids and high-dose combination therapy on achieving control of refractory asthma. Bousquet J., Bateman E. , Boushey H., Busse W., Clark T., Pauwels R., and Pedersen S. 60th Annual Meeting of the American Academy of Allergy, Asthma and Immunology 3/19/2004 San Francisco, CA; USA
An own goal or a real breakthrough? Fardon, T. C. and Lipworth, B. J. Am J Respir Crit Care Med 2005; 171(9):1060; author reply 1061
Bakhireva LN, Schatz M, Chambers CD. Effect of maternal asthma and gestational asthma therapy on fetal growth. Journal of Asthma 2007; 44: 71-76.
Bateman E, Boushey B, Bousquet J, Busse W, Clark T, Pauwels R, Pedersen S. Achievement of guideline-based asthma control with salmeterol/fluticasone propionate compared with fluticasone propionate alone: results of the GOAL study. 4th Triennial World Asthma Meeting Abstract Book, Bangkok, Thailand, February 16-19, 2004. Asthma Foundation of Thailand 2004: 131
Bateman E, Boushey H, Bousquet J, Busse W, Clark T, Pauwels R, Pedersen S. Achieving and maintaining guideline defined asthma control with salmeterol/fluticasone propionate versus fluticasone propionate alone: the results of the GOAL study. Am J Respir Crit Care Med 2004; 169 (7): A87
Bateman E, Pauwels R, Boushey H, Bousquet J, Busse W, Clark T, Pedersen S. Aiming for total control of asthma significantly improves asthma-related quality of life: salmeterol/fluticasone propionate versus fluticasone propionate alone. Am J Respir Crit Care Med 2004; 169 (7): A87
Bateman ED, Boushey HA, Bousquet J, Busse WW, Clark TJH, Pauwels RA, Pedersen SE and The GOAL Investigators Group. Can Guideline-defined Asthma Control be Achieved? The Gaining Optimal Asthma ControL Study. Am J Respir Crit Care Med 2004
Bateman ED, Bousquet J, Busse WW, et al. Stability of asthma control with regular treatment: an analysis of the Gaining Optimal Asthma controL (GOAL) study. Allergy 2008;63(7):932–8.
Bateman ED, Bousquet J, Keech ML, et al. The correlation between asthma control and health status: the GOAL study. European Respiratory Journal 2007; 29: 56-62.
Bateman ED, Edin HM, Sondhi S, Gul N. Asthma-related quality of life in the GOAL study: Baseline results. Eur Respir J 2002; 20 (Suppl 38): 46s
Bons J, Cordier JF, Godard P, Prud’Homme A, Celli I, Bousquet J. Aiming for total control of asthma: the GOAL study design. Rev Fr All Imm Clin 2004;44:367(TT13) [French]
Boushey H, Bateman E, Bousquet J, Busse W, Clark T, Pauwels R, Pedersen S. Improvements in asthma outcomes following 1 year of treatment with salmeterol/fluticasone or fluticasone alone when stepped up to achieve guidelinedefined total control. J Allergy Clin Immunol 2004; 113 (2 Suppl 1): S114-115.
Boushey H, Bateman E, Bousquet J, WBusse W, Clark T, Pauwels R, Pedersen S. Achieving total control of asthma with salmeterol/fluticasone propionate versus fluticasone propionate alone: GOAL study results. 4th Triennial World Asthma Meeting Abstract Book, Bangkok, Thailand, February 16-19, 2004. Asthma Foundation of Thailand 2004: 132
Bousquet J, Bateman E, Boushey H, Busse W, Clark T, Pauwels R, Pedersen S.The effect of oral corticosteroids and high-dose combination therapy on achieving control of refractory asthma. J Allergy Clin Immunol 2004; 113 (2 Suppl 1): S113.
Bousquet J, Bateman E, Briggs A. Aiming for total control of asthma with salmeterol/fluticasone propionate, a cost effective option. European Respiratory Journal Supplement 2005; 26(Suppl. 49): 430.
Bousquet J, Bons J, Godard P, Cordier JF, Desfougeres JL, Prud’Homme A. Aiming for total control of asthma: the GOAL study results. Rev Fr All Imm Clin 2004;44:367(TT16) [French]
Briggs AH, Bousquet J, Wallace MV. Cost-effectiveness of asthma control: an economic appraisal of the GOAL study. Allergy 2006; 61: 531-536.
Busse W, Bateman E, Boushey H, Bousquet J, Clark T, Pauwels R, Pedersen S. Achieving gina/nih guideline-based asthma control with salmeterol/fluticasone compared with fluticasone alone: the results of the GOAL study. J Allergy Clin Immunol 2004; 113 (2 Suppl 1): S114.
Busse W, Bateman E, Boushey H, Bousquet J, Clark T, Pauwels R, Pedersen S. Aiming to achieve total control with salmeterol/fluticasone propionate and fluticasone propionate alone is well tolerated: GOAL 1-year safety data. 4th Triennial World Asthma Meeting Abstract Book, Bangkok, Thailand, February 16-19, 2004. Asthma Foundation of Thailand 2004: 138
Clark T, Bateman E, Boushey H, Bousquet J, Busse W, Pauwels R, Pedersen S. Salmeterol/fluticasone and fluticasone alone are well tolerated over 1 year of treatment stepped up to achieve total control: safety results of the GOAL study. J Allergy Clin Immunol 2004; 113 (2 Suppl 1): S115.
Clark T, Bateman E, Boushey H, Bousquet J, Busse W, Pauwels R, Pedersen S. Time course of achievement of individual clinical goals of asthma treatment: the results of the GOAL study. Am J Respir Crit Care Med 2004; 169 (7): A318
Clark TJ, Bousquet J, Bateman ED, James MH. GOAL (gaining optimal asthma control): a study to assess asthma control. Eur Respir J 2001; 18 (Suppl 33): 175-176s
Clark TJH, Bateman ED on behalf of the GOAL Steering Committee. Aiming for Total Control of asthma in ICS-free patients improves traditional outcomes: Results of the Gaining Optimal
Medical condition
Asthma
Product
fluticasone propionate/salmeterol
Collaborators
Not applicable
Study date(s)
December 2000 to December 2002
Type
Not applicable
Phase
4

Participation criteria

Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English

If you wish to request for full study report, please contact - [email protected]

Results overview

Not applicable

Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2002-19-12

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

Not applicable
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