Last updated: 06/12/2020 07:56:17
A multicentre randomised, double-blind, double-dummy, parallel group comparison of the salmeterol/fluticasone propionate combination product (50/100mcg strength) BID via one DISKUS/ACCUHALER inhaler with salmeterol 50mcg BID via one DISKUS/ACCUHALER inhaler and fluticasone propionate 100mcg BID ...
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 multicentre randomised, double-blind, double-dummy, parallel group comparison of the salmeterol/fluticasone propionate combination product (50/100mcg strength) BID via one DISKUS/ACCUHALER inhaler with salmeterol 50mcg BID via one DISKUS/ACCUHALER inhaler and fluticasone propionate 100mcg BID ...
Trial description: A multicentre randomised, double-blind, double-dummy, parallel group comparison of the salmeterol/fluticasone propionate combination product (50/100mcg strength) BID via one DISKUS/ACCUHALER inhaler with salmeterol 50mcg BID via one DISKUS/ACCUHALER inhaler and fluticasone propionate 100mcg BID ...
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: Asthma control with salmeterol and fluticasone propionate (50/20 micro gram) given twice daily in a single combination diskus (accuhaler) inhaler compared to salmeterol 50 micro gram and fluticasone propionate 205 micro gram given twice daily via two sepa. Ringdal, N, Chapman, K R, Backer, V, Palmqvist, M, Saarelainen, S, and Briggs, M. 8th Annual Congress of the European Respiratory Society 9/19/1998 Geneva Switzerland
Abstract: Combined serevent and fluticasone propionate (50/100ug strength) bd via one diskus (accuhaler) inhaler compared with salmeterol. 50ug and fluticasone propionate 100ug bd via two separate diskus inhalers. Britton, M G MD, Carrillo, T MD, Almeida, J MD, and Wixon, C MD American Lung Association/American Thoracic Society 1998 International Conference 4/24/1998 Chicago IL
Abstract: Synergy between fluticasone propionate and salmeterol from a single combination inhaler (advair seretide) versus delivery via separate inhalers. Pyke, S D, Frith, L, Drake, F, Sykes, J, and Shah, T American Lung Association/American Thoracic Society 97th International Conference 5/18/2001 San Fransisco, Ca
Abstract: Synergy with salmeterol and fluticasone propionate after administration from a single inhaler (seretideâ„¢). Pyke, S. D., Frith, L., Pritchard, J., Johnson, M., Theophilus, A., and Shah, T. 11th Annual Congress of the European Respiratory Society 9/22/2001 Berlin; Germany
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 E, Aubier M, Chapman K, Ringdal N, Huskisson SC. Efficacy of a new combination of salmeterol and FP in patients with varying asthma severity. Eur Respir J 1998; 12 (29): 20s
Bateman ED, Bousquet J, Braunstein GL. Is overall asthma control being achieved? A hypothesis-generating study. Eur Respir J 2001; 17: 589-595
Bateman ED, Britton M, Carrillo J, Almeida J, Wixon C. Salmeterol/fluticasone combination inhaler. A new, effective and well tolerated treatment for asthma. Clin Drug Invest 1998; 16 (3): 193-201
Britton MG, Carrillo T, Almeida J, Wixon C. Combined serevent and FP (50/100mcg strength) bd via one Diskus (Accuhaler) inhaler compared with salmeterol 50mcg and FP 100mcg bd via two separate Diskus inhalers. Am J Respir Crit Care Med 1998; 157 (3): A415
Nelson HS, Chapman KR, Pyke SD, Johnson M, Pritchard JN. Enhanced synergy between fluticasone propionate and salmeterol inhaled from a single inhaler versus separate inhalers. J Allergy Clin Immunol 2003; 112 (1): 29-36
Pyke S, Frith L, Drake F, Sykes J, Shah T. Synergy between fluticasone propionate & salmeterol from a single combination inhaler (Advair Seretide/Advair) vs. delivery via separate inhalers. Am J Respir Crit Care Med 2001; 163 (5): A864
Pyke SD, Frith L, Pritchard J, Johnson, M, Theophilus A, Shah T. Synergy with salmeterol and fluticasone propionate after administration from a single inhaler (Seretide/Advair). Eur Respir J 2001; 18 (Suppl 33): 176s
Medical condition
Asthma
Product
fluticasone propionate/salmeterol
Collaborators
Not applicable
Study date(s)
July 1996 to May 1997
Type
Not applicable
Phase
3
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
1997-09-05
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
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