Last updated: 11/07/2018 18:49:39
A Randomised, Double-Blind, Double-Dummy, Parallel-Group Comparison of Seretide DISKUS/ACCUHALER (50/250?g Strength) b.i.d. with Budesonide 800?g b.i.d. in Adolescents and Adults with Reversible Airways Obstruction
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Randomised, Double-Blind, Double-Dummy, Parallel-Group Comparison of Seretide DISKUS/ACCUHALER (50/250?g Strength) b.i.d. with Budesonide 800?g b.i.d. in Adolescents and Adults with Reversible Airways Obstruction
Trial description: A Randomised, Double-Blind, Double-Dummy, Parallel-Group Comparison of Seretide DISKUS/ACCUHALER (50/250?g Strength) b.i.d. with Budesonide 800?g b.i.d. in Adolescents and Adults with Reversible Airways Obstruction
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: A comparison of seretide (salmeterol 50mcg/fluticasone propionate 250mcb bid) with budesonide (800mcg) bid in moderate asthma. Jenkins, C MD, Woolcock, A J MD, Saarelainen, P MD, and James, M H MD American Lung Association/American Thoracic Society 1999 International Conference 4/23/1999 San Diego CA
Abstract: Advair/seretide (salmeterol 50mcg/fluticasone propionate 250 mcg bid) compared with budesonide (800 mcg bid) during the first week of treatment of moderate asthma. Jenkins, C MD, Woolcock, A MD, Saarelainen, P MD, and James, M MD American Academy of Allergy, Asthma and Immunology 56th Annual Meeting 3/3/2000 San Diego CA
Abstract: Asthma costs with salmeterol/fluticasone combination 50/250mcg bd compared to budesonide 800mcg bd plus formoterol 12meg bd. A.A. Martin, P. J. Whitehead T. P. McCarthy. 99th International Conference of the American Thoracic Society 5/16/2003 Seattle WA
Abstract: Asthma management costs in canada are lower with combination fluticasone propionate - salmeterol (250/50 mcg bid) in a single inhaler than with budesonide 800mcg bid plus eformoterol 12mcg bid via separate inhalers. Rance, L and Musin, A. 68th Annual International Scientific Assembly and the Clinical World Congress on Diseases of the Chest 11/2/2002 San Diego CA
Abstract: Economic evaluation of salmeterol/fluticasone propionate combination versus budesonide/formoterol in the uk. S. Sondhi, A. Martin. 99th International Conference of the American Thoracic Society 5/16/2003 Seattle WA
Abstract: Economic evaluation of salmeterol/fluticasone propionate combination vs budesonide/formoterol in spain. Rodriguez, J. M. and Sondhi, S. 13th Annual Congress of the European Respiratory Society 9/27/2003 Vienna; Austria
Abstract: Economic evaluation of seretide vs budesonide/formoterol in spain. Rodriguez Barrios, J 1 and Sondhi, S 2 9th Conference of the European Society of General Practice and Family Medicine (WONCA) 6/18/2003 Ljubljana; Slovakia
Abstract: comparison of asthma treatment costs of salmeterol/fluticasone combination product 50/250mcg bid with budesonide 800mcg bid plus formoterol 12mcg bid. Price, M J, Karia, N, and Whitehead, P World Congress on Lung Health and 10th European Respiratory Society Annual Congress 8/30/2000 Florence Italy
Abstract: economic evaluation of salmeterol/fluticasone combination vs budesonide plus formoterol in spain. Alonso, J. F., Badiola, C., and Kielhorn, A. 11th Annual Congress of the European Respiratory Society 9/22/2001 Berlin; Germany
Abstract: superior overall control of moderate to severe asthma with salmeterol/fluticasone propionate (fp) combination (50/250 mcg bd) compared with a three-fold higher dose of budesonide (800 mcg bd). Jenkins, C, Wollcock, A, and James, M World Congress on Lung Health and 10th European Respiratory Society Annual Congress 8/30/2000 Florence Italy
Abstract: total asthma control with salmeterol/fluticasone propionate (fp) combination compared with budesonide at a higher microgram steroid dose. Bateman, E D, Jenkins, Cl, Woolcock, A, and Sykes, J World Congress on Lung Health and 10th European Respiratory Society Annual Congress 8/30/2000 Florence Italy
Bateman ED, Jenkins C, Woolcock A, Sykes J. ‘Total’ asthma control with salmeterol/fluticasone propionate (FP) combination compared with budesonide at a higher microgram steroid dose. Eur Respir J 2000; 16 (Suppl 31): 457s
Becker I, Kielborn A, Price MJ, Volmer T, Lloyd AC. Cost-effectiveness of salmeterol/fluticasone combination product and budesonide in asthma patients in Germany. Eur Respir J 1999; 14 (Suppl 30): 124s P854
Chew FT, Lim TK, Lee BW, Seah L. Cost-effectiveness analyses comparing Seretide/Advair (salmeterol/fluticasone propionate combination product) and budesonide for the treatment of asthma in Singapore. Eur Respir J 2000; 16 (Suppl 31): 456s
Jenkins C, Woolcock A, James M. Superior overall control of moderate to severe asthma with salmeterol/fluticasone (FP) combination (50/250 mcg bd) compared with a three-fold higher dose of budesonide (800 mcg bd). Eur Respir J 2000; 16 (Suppl 31): 456s
Jenkins C, Woolcock AJ, Saarelainen P, James MH. A comparison of Seretide/Advair (salmeterol 50 mcg/fluticasone propionate 250 mcg bid) with budesonide (800 mcg) bid in moderate asthma. Am J Respir Crit Care Med 1999; 159 (3 part 2): A637
Jenkins C, Woolcock AJ, Saarelainen P, James MH. Advair/Seretide/Advair (salmeterol 50mcg/fluticasone propionate 250mcg bid) compared with budesonide (800mcg bid) during the first week of treatment of moderate asthma. J Allergy Clin Immunol 2000; 105 (1 part 2): S161 (493)
Jenkins C, Woolcock AJ, Saarelainen P, Lundback B, James MH. Salmeterol/fluticasone propionate 50/250 mcg twice daily is more effective than budesonide 800 mcg twice daily in treating moderate to severe asthma. Respir Med 2000; 94 (7): 715-723
Juniper EF, Jenkins C, Price MJ, Thwaites RMA, James MH. Quality of life of asthma patients treated with salmeterol/fluticasone propionate combination product and budesonide. Eur Respir J 1999; 14 (Suppl 30): 370s P2460
Lloyd A, Browning D, Shrewsbury S. Cost-effectiveness of salmeterol/fluticasone combination product and budesonide in the United Kingdom (asthma). Am J Respir Crit Care Med 2000; 161 (3 part 2; Suppl 1): A196
Lundback B, Jenkins C, Price MJ, Thwaites RMA, on behalf of an international study group. Cost-effectiveness of salmeterol/fluticasone propionate combination product (50/250?g) and budesonide 800 ?g twice daily in the treatment of adults and adolescents with asthma. Respir Med 2000; 94 (7): 724-732
Lundback B, Price MJ, Thwaites RMA, Karia N, James MH, Nyth A. The cost-effectiveness of salmeterol/fluticasone propionate combination product and budesonide in asthma. Eur Respir J 1999; 14 (Suppl 30): 370s P2457
Markham A, Adkins JC. Inhaled salmeterol/fluticasone propionate combination: A pharmacoeconomic review of its use in the management of asthma. Pharmacoeconomics 2000; 18 (6): 591-608
Martin AA, Whitehead PJ, McCarthy TP. Asthma costs with salmeterol/fluticasone combination 50/250mcg bd compared to budesonide 800mcg bd plus formoterol 12mcg bd. Am J Respir Crit Care Med 2003; 176 (7): A893
Parnaby A, Lloyd A, Browning D, McCarthy TP. A comparison of the cost-effectiveness of salmeterol/fluticasone combination inhaler and budesonide in the management of asthma. Thorax 2000; 55 (Suppl 3): A64
Rance L, Musin A. Asthma management costs in Canada are lower with combination fluticasone propionate / salmeterol (250/50 MCG BID) in a single inhaler than with budesonide 800 MCG BID plus eformoterol 12MCG BID via separate inhalers. Chest 2002; Abs No S6.
Sondhi S, Martin A. Economic evaluation of salmeterol/fluticasone propionate combination versus budesonide/formoterol in the UK. Am J Respir Crit Care Med 2003; 167 (7): A496
Medical condition
Asthma
Product
fluticasone propionate/salmeterol
Collaborators
Not applicable
Study date(s)
April 1998 to July 1998
Type
Not applicable
Phase
4
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
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
1998-09-07
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
Participate in clinical trial
Access to clinical trial data by researchers
Visit website