Last updated: 11/07/2018 18:46:24
A 12-Month, Open-Label, Stratified Study to Assess the Long-Term Safety of Salmeterol/Fluticasone Propionate/HFA134a Inhalation Aerosol at Doses of 50/100mcg, 50/250mcg, and 50/500mcg BID in Adolescent and Adult Subjects with Asthma
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 12-Month, Open-Label, Stratified Study to Assess the Long-Term Safety of Salmeterol/Fluticasone Propionate/HFA134a Inhalation Aerosol at Doses of 50/100mcg, 50/250mcg, and 50/500mcg BID in Adolescent and Adult Subjects with Asthma
Trial description: A 12-Month, Open-Label, Stratified Study to Assess the Long-Term Safety of Salmeterol/Fluticasone Propionate/HFA134a Inhalation Aerosol at Doses of 50/100mcg, 50/250mcg, and 50/500mcg BID in Adolescent and Adult Subjects with Asthma
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: Fluticasone propionate/salmeterol hfa mdi therapy provides effective control in the long-term (1year) management of patients with persistent asthma. Cowie, R, Boulet, L P, Stepner, N, Simms, L, Johnson, D, and Scott, C American Lung Association/American Thoracic Society 97th International Conference 5/18/2001
Abstract: Fluticasone/salmeterol combination (fsc) is safe and provides effective long-term (52 week) control in the management of patients with persistent asthma (pa). Keith, P., D'Urzo, A., Stepner, N., Simms, L., Scott, C., and House, K. 11th Annual Congress of the European Respiratory Society 9/22/2001 Berlin; Germany
Abstract: The salmeterol/fluticasone propionate combination 50/100 î¼g bid is effective as initial maintenance therapy in mild and moderate asthmatics. Lange, M. L., House, K. W., Scott, C. A., Shah, T. P., and Akveld, M. L. M. 11th Annual Congress of the European Respiratory Society 9/22/2001 Berlin; Germany
Cowie R, Boulet LP, Stepner N, Simms L, Johnson D, Scott C, House K. Fluticasone propionate/salmeterol (FSC) HFA MDI therapy provides effective control in the long-term (1 year) management of patients with persistent asthma (PA). AM. THORAC. SOC. ANNU. MEET. 2001;(ABSTRACTS CD):D31-K39.
Cowie R, Boulet LP, Stepner N, Simms L, Johnson D, Scott C, House K. Fluticasone propionate/salmeterol (FSC) HFA MDI therapy provides effective control in the long-term (1 year) management of patients with persistent asthma (PA). Am J Respir Crit Care Med 2001; 163 (5 part 2): A862
Keith P, D’Urzo A, Stepner N et al. Fluticasone/salmeterol combination (FSC) is safe and provides effective long-term (52 week) control in the management of patients with persistent asthma (PA). Eur Respir J 2001; 18 (Suppl 33): 176s
Medical condition
Asthma
Product
fluticasone propionate/salmeterol
Collaborators
Not applicable
Study date(s)
January 1999 to July 2000
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
2000-04-07
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
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