Last updated: 11/07/2018 18:49:49
A Randomised, Double-Blind, Double-Dummy, Parallel-Group Comparison of SERETIDE DISKUS/ACCUHALER (50/100?g Strength) twice daily (bid) with Budesonide 400?g bid 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 (50/100?g Strength) twice daily (bid) with Budesonide 400?g bid in Adolescents and Adults with Reversible Airways Obstruction
Trial description: A Randomised, Double-Blind, Double-Dummy, Parallel-Group Comparison of SERETIDE DISKUS/ACCUHALER (50/100?g Strength) twice daily (bid) with Budesonide 400?g bid 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: Comparable overall control of moderate asthma with salmeterol/fluticasone propionate (fp) combination (50/100 mcg bd) compared with a four-fold higher dose of budesonide (400 mcg bd). Bateman, E, Johansson, G, and Drake, F World Congress on Lung Health and 10th European Respiratory Society Annual Congress 8/30/2000 Florence Italy
Abstract: Seretidelm 50/100 once daily is more effective than budesonide 400mcg once daily in mild asthma. R. Pauwels, 1. Smiltenal A. Bagdonas E. Ehraz@ R. Firthl. 100th International Conference of the American Thoracic Society 5/21/2004 Orlando FL
Abstract: Seretidine (salmeterol 50mcg/fluticasone propionate 100mcg bid) compared with budesonide (400mcg bid) in mild to moderate asthma. Johansson, G MD, McIvor, R A MD, Purello D'Ambrosio, F MD, Gratziou, MD, and James, M H MD American Lung Association/American Thoracic Society 1999 International Conference 4/23/1999 San Diego CA
Abstract: The cost-effectiveness of achieving asthma control with the combination products salmeterol/fluticasone propionate or formoterol/budesonide. Price, M. J. and Briggs, A. H. 11th Annual Congress of the European Respiratory Society 9/22/2001 Berlin; Germany
Abstract: Withdrawal of inhaled corticosteroids under cover of the combination of leucotriene receptor antagonists plus cromoglycate in mild to moderate asthma. Christopoulos, A., Panteli, L., Feggu, E., Economopoulu, E., Katsaru, E., and Goudas, P. 17th World Asthma Congress 7/5/2003 St. Petersburg; Russia
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
Bateman ED, Johansson G, Drake F. Comparable overall control of moderate asthma with salmeterol/fluticasone propionate (FP) combination (50/100 mcg bd) compared with a four-fold higher dose of budesonide (400 mcg bd). Eur Respir J 2000; 16 (Suppl 31): 456s
Johansson G, McIvor RA, Purello D'Ambrosio F, Gratziou C, James MH. Comparison of salmeterol/fluticasone propionate combination with budesonide in patients with mild-to-moderate asthma. Clin Drug Invest 2001; 21 (9): 633-642
Johansson G, McIvor RA, Purello D’ Ambrosio FP, Gratziou D, James MH. Seretide/Advair (salmeterol 50 mcg/fluticasone propionate 100 mcg bid) compared with budesonide (400 mcg bid) in mild to moderate asthma. Am J Respir Crit Care Med 1999; 159 (3 part 2): A637
Johansson G, McIvor RA, Purello D’Ambrosio F et al. Salmeterol/fluticasone propionate combination dry powder inhaler (50/100 mcg bid) is more effective than budesonide (400 mcg bid) in mild to moderate asthma. Eur Respir J 1998; 12 (Suppl 29): 20S, P162
Medical condition
Asthma
Product
fluticasone propionate/salmeterol
Collaborators
Not applicable
Study date(s)
April 1997 to March 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
1998-04-03
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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