Last updated: 11/07/2018 19:16:28

A multicentre, randomised, double-blind, double-dummy, parallel-group, three-month comparison of the salmeterol/fluticasone propionate combination product (2x25/50mcg strength) bd via the pressurised metered dose inhaler with salmeterol/fluticasone propionate combination product (1x50/100mcg str ...

GSK study ID
SFCB3022
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, randomised, double-blind, double-dummy, parallel-group, three-month comparison of the salmeterol/fluticasone propionate combination product (2x25/50mcg strength) bd via the pressurised metered dose inhaler with salmeterol/fluticasone propionate combination product (1x50/100mcg str ...
Trial description: A multicentre, randomised, double-blind, double-dummy, parallel-group, three-month comparison of the salmeterol/fluticasone propionate combination product (2x25/50mcg strength) bd via the pressurised metered dose inhaler with salmeterol/fluticasone propionate combination product (1x50/100mcg str ...
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: Benefits of fluticasone propionates/salmeterol hfa mdi are apparent on the first day of dosing. O'Brien, J, Carlos-Palma, A, Bogolubov, M, Davies, P, and Payne, E American Lung Association/American Thoracic Society 97th International Conference 5/18/2001 San Francisco CA
Abstract: Clinical equivalence of salmeterol/fluticasone propionate combination 5/500 bid delivered via metered dose inhaler (mdi) or diskus in patients with reversible airways obstruction. van Noord, J A MD, Lill, H MD, Carillo, T MD, and Davies, P MD American Lung Association/American Thoracic Society 96th International Conference 5/5/2000 Toronto ON Canada
Abstract: Clinical equivalence of salmeterol/fluticasone propionate combination product (seretide) 50/500mcg bd delivered via diskus or cfc-free metred dose inhaler (mdi) in patients with reversible airways obstruction. Davies, P, Van Noord, J A, Lill, H, Carillo, T, and Greefhorst, A P 19th Congress of the European Academy of Allergology and Clinical Immunology (EAACI) 7/1/2000 Lisbon Portugal
Abstract: Comparison of salmeterol/fluticasone propionate combination 50/100 bid delivered via metered dose inhaler or diskus in patients with reversible airways obstruction. Bateman, E D MD, Beasley, R MD, Silins, V MD, and Bogoublubov, M MD American Lung Association/American Thoracic Society 96th International Conference 5/5/2000
Abstract: Effectiveness of a new salmeterol/fluticasone propionate (50/500 micro gram) combination inhaler in patients with reversible airways obstruction. Pieters, W R, Steinmetz, K O, Aubier, M, Johnson, L, Gomez, E, and Bogolubov, M 8th Annual Congress of the European Respiratory Society 9/19/1998 Geneva Switzerland
Bateman ED, Beasley R, Silins V, Bogolubov M. Comparison of salmeterol/fluticasone propionate combination 50/100 bid delivered via metered dose inhaler or Diskus in patients with reversible airways obstruction. Am J Respir Crit Care Med 2000; 161 (3 part 2; Suppl 1);
Bateman ED, Silins V, Bogolubov M. Clinical equivalence of salmeterol/fluticasone propionate in combination (50/100mcg twice daily) when administered via a chlorofluorocarbon-free metered dose inhaler or dry powder inhaler to patients with mild-to-moderate asthma. Respir Med 2001; 95 (3) : 136-146
O’Brien J, Carlos-Palma A, Bogolubov M, Davies P, Payne E. Benefits of fluticasone propionate/salmeterol (Advair/Seretide/Advair) HFA MDI are apparent on the first day of dosing. Am J Respir Crit Care Med 2001; 163 (5 part 2): A864
Silins V, Beasley R, Linnhoff A, Bogolubov M. Comparison of salmeterol/fluticasone propionate combination therapy 50/100 bd delivered via a CFC-free metered dose inhaler (MDI) or Diskus in patients with persistent mild to moderate asthma. Eur J Allergy & Clin Immunol; 2000; 55 (Suppl 63): 2
Medical condition
Asthma
Product
fluticasone propionate/salmeterol
Collaborators
Not applicable
Study date(s)
March 1998 to June 1999
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
1999-16-06

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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