Last updated: 11/07/2018 19:16:15

A multicentre randomized, double-blind, double-dummy, parallel-group comparison of the salmeterol/fluticasone propionate combination product (50/500mcg strength) BD via one DISKUS/Accuhaler inhaler with salmeterol 50mcg BD via one DISKUS/Accuhaler and fluticasone propionate 500mcg BD via another ...

GSK study ID
SFCB3019
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 randomized, double-blind, double-dummy, parallel-group comparison of the salmeterol/fluticasone propionate combination product (50/500mcg strength) BD via one DISKUS/Accuhaler inhaler with salmeterol 50mcg BD via one DISKUS/Accuhaler and fluticasone propionate 500mcg BD via another ...
Trial description: A multicentre randomized, double-blind, double-dummy, parallel-group comparison of the salmeterol/fluticasone propionate combination product (50/500mcg strength) BD via one DISKUS/Accuhaler inhaler with salmeterol 50mcg BD via one DISKUS/Accuhaler and fluticasone propionate 500mcg BD via another ...
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: Cost effectiveness of fluticasone propionate/ salmeterol combination product and fluticasone propionate/ montelukast in asthma. Pieters, W R, Wilson, K K, Smith, H C E, and Tamminga, J J American Lung Association/American Thoracic Society 97th International Conference 5/18/2001 San Fransico, CA
Abstract: Econornic evaluation of salmeterol/fluticasone propionate combination vs budesonidelformoterol in spain. J. M. Rodriguez, S. Sondhi 13th Annual Congress of the European Respiratory Society 9/27/2003 Vienna Austria
Abstract: The cost-effectiveness of salmeterol/fluticasone propionate 50/500 micro gram combinatin inhaler versus fluticasone propionate 500 micro gram in patients with chronic asthma. Pieters, W R, Sondhi, S, Price, M J, Thwaites, R M A, and Nyth, A 1999 Annual Congress of the European Respiratory Society 10/9/1999 Madrid Spain
Aubier M, Pieters WR, Schlosser NJJ, Steinmetz K-O. Salmeterol/fluticasone propionate (50/500 ?g) in combination in a Diskus inhaler (Seretide/Advair) is effective and safe in the treatment of steroid-dependent asthma. Respir Med 1999; 93 (12): 876-884
Lundback B, Pieters WR, Johansson G, Palmqvist M, Price MJ, Sondhi S, et al. Cost-effectiveness analyses of salmeterol/fluticasone propionate combination product and fluticasone propionate in patients with asthma I: Introduction and Overview. Phamacoeconomics 1999; 16 (Suppl 2): 1-8
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
Pieters WR, Lundback B, Johansson G, Palmqvist M, Price MJ, Sondhi S, et al. Cost-effectiveness analyses of salmeterol/fluticasone propionate combination product and fluticasone propionate in patients with asthma. II: Study methodologies. Phamacoeconomics 1999; 16 (Suppl 2): 9-14
Pieters WR, Lundback B, Sondhi S, Price MJ, Thwaites RMA. Cost-effectiveness analysis of salmeterol/fluticasone propionate 50/500?g versus fluticasone propionate 500?g in patients with corticosteroid-dependent asthma. V: Results. Phamacoeconomics 1999; 16 (Suppl 2): 29-34
Pieters WR, Sondhi S, Price MJ, Thwaites RMA, Nyth A. The cost-effectiveness of salmeterol/fluticasone propionate 50/500 mcg combination inhaler versus fluticasone propionate 500 mcg in patients with chronic asthma. Eur Respir J 1999; 14 (Suppl 30): 370s; P2458
Pieters WR, Steinmetz K-O, Aubier M, Johnson L, Gomez E, Bogolubov M. Effectiveness of a new salmeterol/fluticasone propionate (50/500 mcg) combination inhaler in patients with reversible airways obstruction. Eur Respir J 1998; 12 (Suppl 28): 35s-36s
Salmeterol/fluticasone propionate versus fluticasone propionate plus montelukast: a cost-effective comparison for asthma. Pieters, W. R., Wilson, K. K., Smith, H. C., Tamminga, J. J., and Sondhi, S. Treat Respir Med 2005; 4. 4(2. 2):129-38, 129-38.
Schlosser NJJ, Steinmetz K-O, Aubier M, Gomez E, Wixon C. Evaluation of long term safety of salmeterol/fluticasone propionate (50/500 mcg) combination inhaler in patients with reversible airways obstruction. Eur Respir J 1998; 12 (Suppl 28): 35s
Stempel DA. Salmeterol/fluticasone propionate combination product in asthma - An evaluation of its cost effectiveness vs fluticasone propionate – Foreword. Phamacoeconomics 1999; 16 (Suppl 2): U6-U7
Medical condition
Asthma
Product
fluticasone propionate/salmeterol
Collaborators
Not applicable
Study date(s)
June 1996 to November 1997
Type
Not applicable
Phase
3

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

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
1997-24-11

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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