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Last Updated: September 24, 2021

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CLINICAL TRIALS PROFILE FOR FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

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505(b)(2) Clinical Trials for Fluticasone Propionate; Salmeterol Xinafoate

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Combination NCT00497237 ↗ Clinical Trial of the Efficacy and Safety of Beclomethasone Dipropionate Plus Formoterol vs Fluticasone Propionate Plus Salmeterol in the 6 Months Step Down Treatment of Asthma Completed Chiesi Farmaceutici S.p.A. Phase 3 2007-04-01 Asthma is a serious global health problem. People of all ages in countries throughout the world are affected by this chronic airway disorder that can be severe and sometimes fatal. The prevalence of asthma is increasing everywhere, especially among children.According to international guidelines, once control of asthma is achieved and maintained for at least 3 months, a gradual reduction of the maintenance therapy should be tried in order to identify the minimum therapy required to maintain control. This will help reduce the risk of side effects and enhance patient adherence to the treatment plan. Reduction of therapy in patients on combination therapy should begin with a reduction in the dose of inhaled glucocorticosteroid.1 The present study is designed to evaluate if patients with controlled asthma treated with FP 1000 mcg + salmeterol 100 mcg daily can be stepped down. Stepping-down will be attempted with two medications: a new combination of extrafine beclomethasone dipropionate 400 mcg + formoterol 24 mcg daily (test medication, Foster™) and, alternatively, fluticasone propionate 500 mcg + salmeterol 100 mcg daily(reference medication) without losing asthma control.If this hypothesis will be confirmed, the present study will demonstrate that asthma control can be maintained with less than half the dose of inhaled corticosteroid and with less medical costs. Given the aims of this study, the population to be monitored includes adult patients with moderate persistent asthma, which can be defined controlled according to the current guidelines under standard stabilised treatment. The intended treatment duration is therefore designed to ensure that good control of asthma is firmly achieved before stepping down the treatment (8 weeks run-in period), but also that the condition of the patients are followed long enough (24 weeks comparative treatment period) to ensure that a new stable condition is also obtained and properly monitored.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Fluticasone Propionate; Salmeterol Xinafoate

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00102882 ↗ Study Of Asthma And Genetics In Patients To Be Treated With Fluticasone Propionate/Salmeterol Or Salmeterol Xinafoate Completed GlaxoSmithKline Phase 4 2004-10-01 This study may last up to 36-38 weeks. Patients will visit the clinic 11 times. A blood sample will be taken at Visit 1 to look at subjects' genes. Breathing tests will be done during the study. Study medicines and procedures will be provided at no cost. Patients will be treated with VENTOLIN (8 wks), ATROVENT (8 wks), then ADVAIR or SEREVENT (16 wks). ADVAIR and SEREVENT are FDA approved for the treatment of asthma in patients 4 years of age and older.
NCT00233051 ↗ Evaluating Genes in Sputum to Measure Drug Response in COPD Terminated GlaxoSmithKline N/A 2003-04-01 The purpose of this research study is to determine whether analysis of genes in sputum is a useful noninvasive technique for measuring response to drugs in patients with COPD. We propose to use polymerase chain reaction to evaluate gene expression in induced sputum from adult current smokers with moderate COPD, adult former smokers with moderate COPD. This study is designed to determine whether changes in expression of previously-identified inflammatory markers in induced sputum can be detected in response to drug therapy in COPD and to evaluate potential differences in the expression of these markers in adult smokers with and without COPD. Pre- and post-treatment serum will be obtained to facilitate proteomic analysis of therapeutic response as well. Changes in sputum gene expression in response to treatment will be the primary outcome variable in this study. Secondary outcomes will include changes in lung function, as well as changes in induced sputum inflammation. These endpoints will be evaluated before and directly after 6 weeks of randomly-assigned treatment with either salmeterol xinafoate or fluticasone propionate/50mcg salmeterol xinafoate combination DPI bid. Endpoints will be re-evaluated following a 4 week wash-out period.
NCT00233051 ↗ Evaluating Genes in Sputum to Measure Drug Response in COPD Terminated National Jewish Health N/A 2003-04-01 The purpose of this research study is to determine whether analysis of genes in sputum is a useful noninvasive technique for measuring response to drugs in patients with COPD. We propose to use polymerase chain reaction to evaluate gene expression in induced sputum from adult current smokers with moderate COPD, adult former smokers with moderate COPD. This study is designed to determine whether changes in expression of previously-identified inflammatory markers in induced sputum can be detected in response to drug therapy in COPD and to evaluate potential differences in the expression of these markers in adult smokers with and without COPD. Pre- and post-treatment serum will be obtained to facilitate proteomic analysis of therapeutic response as well. Changes in sputum gene expression in response to treatment will be the primary outcome variable in this study. Secondary outcomes will include changes in lung function, as well as changes in induced sputum inflammation. These endpoints will be evaluated before and directly after 6 weeks of randomly-assigned treatment with either salmeterol xinafoate or fluticasone propionate/50mcg salmeterol xinafoate combination DPI bid. Endpoints will be re-evaluated following a 4 week wash-out period.
NCT00403286 ↗ A Dose-Finding Study Evaluating Safety and Efficacy in Patients With Chronic Obstructive Pulmonary Disease Completed Dey Phase 2 2006-11-01 The purpose of the study is to determine the appropriate dose of fluticasone propionate/formoterol fumarate that is closest to Advair Diskus (fluticasone propionate/salmeterol xinafoate using pulmonary function, safety, and levels of study drug in blood plasma in patients with chronic obstructive pulmonary disease.
NCT00448435 ↗ Clinical Assessment Of GW815SF HFA MDI In Pediatric Patients With Bronchial Asthma Completed GlaxoSmithKline Phase 3 2007-04-01 To evaluate the efficacy and safety of GW815SF HFA MDI 25/50µg 1 inhalation bid in comparison with concomitant treatment with salmeterol xinafoate DPI 25µg 1 inhalation bid plus fluticasone propionate DPI 50µg 1 inhalation bid in paediatric patients with asthma. To evaluate the safety of long-term treatment of GW815SF HFA MDI 25/50µg 1 inhalation bid in paediatric patients with asthma.
NCT00497237 ↗ Clinical Trial of the Efficacy and Safety of Beclomethasone Dipropionate Plus Formoterol vs Fluticasone Propionate Plus Salmeterol in the 6 Months Step Down Treatment of Asthma Completed Chiesi Farmaceutici S.p.A. Phase 3 2007-04-01 Asthma is a serious global health problem. People of all ages in countries throughout the world are affected by this chronic airway disorder that can be severe and sometimes fatal. The prevalence of asthma is increasing everywhere, especially among children.According to international guidelines, once control of asthma is achieved and maintained for at least 3 months, a gradual reduction of the maintenance therapy should be tried in order to identify the minimum therapy required to maintain control. This will help reduce the risk of side effects and enhance patient adherence to the treatment plan. Reduction of therapy in patients on combination therapy should begin with a reduction in the dose of inhaled glucocorticosteroid.1 The present study is designed to evaluate if patients with controlled asthma treated with FP 1000 mcg + salmeterol 100 mcg daily can be stepped down. Stepping-down will be attempted with two medications: a new combination of extrafine beclomethasone dipropionate 400 mcg + formoterol 24 mcg daily (test medication, Foster™) and, alternatively, fluticasone propionate 500 mcg + salmeterol 100 mcg daily(reference medication) without losing asthma control.If this hypothesis will be confirmed, the present study will demonstrate that asthma control can be maintained with less than half the dose of inhaled corticosteroid and with less medical costs. Given the aims of this study, the population to be monitored includes adult patients with moderate persistent asthma, which can be defined controlled according to the current guidelines under standard stabilised treatment. The intended treatment duration is therefore designed to ensure that good control of asthma is firmly achieved before stepping down the treatment (8 weeks run-in period), but also that the condition of the patients are followed long enough (24 weeks comparative treatment period) to ensure that a new stable condition is also obtained and properly monitored.
NCT00527826 ↗ Influence Of Salmeterol Xinafoate/Fluticasone Propionate (50/500 µg BID) On The Course Of The Disease And Exacerbation Frequency In COPD Patients Gold Stage III And IV Completed GlaxoSmithKline Phase 4 2007-11-01 This is a 12 month randomized, open-label, parallel-group study to obtain data on the frequency and variability of exacerbations in severe and very severe Chronic Obstructive Pulmonary Disease (COPD) patients (Global Initiative for Chronic Obstructive Lung Disease (GOLD) Stage III and IV) receiving salmeterol xinafoate and fluticasone propionate either in fixed combination (SFC) or from separate inhalers (Sal/FP) with standard therapy. 200 subjects will be enrolled in approximately 30 study centres in Germany. Data on health care utilisation will be collected to compare direct costs associated with COPD in these two groups. Baseline data will be collected for all subjects at Visit 1 and eligible subjects will be randomized to receive either SFC 50/500 µg bid (twice daily) as fixed combination or Sal 50 µg bid (twice daily) and FP 500 µg bid (twice daily) concurrently over 52 weeks. Subjects will return for study visits every two to three months until week 52. Additional telephone calls will be made between scheduled visits every 4 weeks. Assessments will include monitoring of frequency of exacerbations, health care utilisation (including emergency visits and hospitalizations) and rescue medication, lung function, drug compliance, health-related quality of life (SGRQ = St George's Respiratory Questionnaire) and safety.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Fluticasone Propionate; Salmeterol Xinafoate

Condition Name

Condition Name for Fluticasone Propionate; Salmeterol Xinafoate
Intervention Trials
Asthma 13
Bioequivalence 10
Pulmonary Disease, Chronic Obstructive 6
Chronic Obstructive Pulmonary Disease 2
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Condition MeSH

Condition MeSH for Fluticasone Propionate; Salmeterol Xinafoate
Intervention Trials
Asthma 14
Pulmonary Disease, Chronic Obstructive 10
Lung Diseases 10
Lung Diseases, Obstructive 9
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Clinical Trial Locations for Fluticasone Propionate; Salmeterol Xinafoate

Trials by Country

Trials by Country for Fluticasone Propionate; Salmeterol Xinafoate
Location Trials
United States 133
Greece 11
Germany 10
Australia 7
South Africa 6
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Trials by US State

Trials by US State for Fluticasone Propionate; Salmeterol Xinafoate
Location Trials
Texas 7
California 6
North Carolina 6
Missouri 6
Florida 6
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Clinical Trial Progress for Fluticasone Propionate; Salmeterol Xinafoate

Clinical Trial Phase

Clinical Trial Phase for Fluticasone Propionate; Salmeterol Xinafoate
Clinical Trial Phase Trials
Phase 4 6
Phase 3 4
Phase 2 5
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Clinical Trial Status

Clinical Trial Status for Fluticasone Propionate; Salmeterol Xinafoate
Clinical Trial Phase Trials
Completed 21
Recruiting 8
Active, not recruiting 4
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Clinical Trial Sponsors for Fluticasone Propionate; Salmeterol Xinafoate

Sponsor Name

Sponsor Name for Fluticasone Propionate; Salmeterol Xinafoate
Sponsor Trials
GlaxoSmithKline 13
Respirent Pharmaceuticals Co Ltd. 10
BECRO Ltd. 10
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Sponsor Type

Sponsor Type for Fluticasone Propionate; Salmeterol Xinafoate
Sponsor Trials
Industry 35
Other 16
NIH 1
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