Last updated: 11/07/2018 19:12:35
A Randomized, Double-Blind, Double-Dummy, Parallel-Group, Comparative Clinical Trial Evaluating Fluticasone Propionate/Salmeterol Xinafoate (250/50mcg twice daily via Diskus) to Ipratropium Bromide/Albuterol Sulfate (36mcg/206mcg four times a day) Inhalation Aerosol in Subjects with Chronic Obstructive Pulmondary Disease (COPD)
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 Randomized, Double-Blind, Double-Dummy, Parallel-Group, Comparative Clinical Trial Evaluating Fluticasone Propionate/Salmeterol Xinafoate (250/50mcg twice daily via Diskus) to Ipratropium Bromide/Albuterol Sulfate (36mcg/206mcg four times a day) Inhalation Aerosol in Subjects with Chronic Obstructive Pulmondary Disease (COPD)
Trial description: A Randomized, Double-Blind, Double-Dummy, Parallel-Group, Comparative Clinical Trial Evaluating Fluticasone Propionate/Salmeterol Xinafoate (250/50mcg twice daily via Diskus) to Ipratropium Bromide/Albuterol Sulfate (36mcg/206mcg four times a day) Inhalation Aerosol in Subjects with Chronic Obstructive Pulmondary Disease (COPD)
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: Lung function and symptom improvements with fluticasone propionate/salmeterol 250/50 and ipratropium/albuterol in patients with mild to moderate copd. Knobil, K. MD, Watkins, M. PharmD, Emmett, A. MS, and Kalberg, C. PhD 101st International Conference of the American Thoracic Society 5/20/2005 San Diego, CA; USA
Abstract: Lung function and symptom improvements with fluticasone propionate/salmeterol 250/50 and ipratropium/albuterol in patients wtih mild to moderate copd. Knobil, K., Watkins, M., Emmett, A., and Kalberg, C. 15th Annual Congress of the European Respiratory Society 9/17/2005 Copenhagen; Denmark
Abstract: Response to therapy with fluticasone propionate/salmeterol 250/50 or ipratropium/albuterol in population subgroups of patients with copd. Knobil, K., Watkins, M., Brown, C., Emmett, A., and Kalberg, C. 15th Annual Congress of the European Respiratory Society 9/17/2005 Copenhagen; Denmark
Abstract: Response to therapy with fluticasone propionate/salmeterol 250/50mcg or ipratropium/albuterol in population subgroups of patients with copd. Knobil, K. MD, Watkins, M. PharmD, Brown, C. PharmD, Emmett, A. MS, and Kalberg, C. PhD 101st International Conference of the American Thoracic Society 5/20/2005 San Diego, CA; USA
Abstract: Safety and efficacy of albuterol vs. albuterol/ipratropium bromide in copd subjects on fluticasone/salmeterol 500/50. Balkissoon, R. C. MD, Murphy, J. R. Ph. D, and Make, B. MD 101st International Conference of the American Thoracic Society 5/20/2005 San Diego, CA; USA
Abstract: Symptom status improvements with fluticasone propionate/salmeterol 250/50 and ipratropium/albuterol in patients with copd. Knobil, K. MD, Watkins, M. PharmD, Emmett, A. MS, Borker, R. PhD, and Kalberg, C. PhD 101st International Conference of the American Thoracic Society 5/20/2005 San Diego, CA; USA
Donohue J, Kalberg C, Emmett A, Merchant K, Knobil K. Fluticasone/salmeterol combination (250/50) provides greater improvement in lung function and symptoms than the combination of ipratropium/albuterol in patients with COPD. Chest 2003;124(4):128S
Knobil K, Watkins M, Merchant K, Emmett A, Schweiker S, Yates J. Improved small airway function with fluticasone propionate/salmeterol versus ipratropium/albuterol therapy in patients with chronic obstructive pulmonary disease (COPD). Chest 2003;24(4):128S-a
Make B, Hanania NA, ZuWallack R, Kalberg C, Emmet A, Brown CP, Knobil K. The efficacy and safety of inhaled fluticasone propionate/salmeterol compared with ipratropium/albuterol in the treatment of COPD. Clinical Therapeutics 2005; 27(5): 532-542.
Make BJ, Cicale MJ, Kalberg CJ, Emmett AH, Knobil K. A Randomized, Double-Blind Trial Comparing Fluticasone/Salmeterol via DISKUS to Ipratropium/Albuterol in Patients with Chronic Obstructive Pulmonary Disease (COPD). Am J Respir Crit Care Med 2004. 169(7): A597
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
fluticasone propionate/salmeterol
Collaborators
Not applicable
Study date(s)
December 2001 to January 2003
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
Clinical study report
Available language(s): English
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
2003-28-01
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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