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Last Updated: January 26, 2023

CLINICAL TRIALS PROFILE FOR SALMETEROL XINAFOATE


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505(b)(2) Clinical Trials for 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.
New Formulation NCT02254226 ↗ Pharmacokinetics of Salmeterol (Serevent®) After Inhalation With Metered Dose Inhaler (MDI) and Diskus® in Healthy Male Volunteers Completed Boehringer Ingelheim Phase 1 2004-11-01 1. To compare the systemic drug exposure of 100 μg Serevent ® Diskus ® with that of 50 μg Serevent ® MDI with sufficient precision so that in combination with a second trial it can be demonstrated that the systemic drug exposure of a new formulation of salmeterol xinafoate is not superior to that of Serevent ® MDI 2. To test a system of ordered null hypotheses regarding the exposure of two dose levels of Serevent ® Diskus ® and Serevent ® MDI 3. To get data about the systemic drug exposure of 25 μg Serevent ® MDI and of 50 μg Serevent ® Diskus ®
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for 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.
NCT00127166 ↗ Two Investigational Drugs in the Prevention of Airway Constriction Brought on by Exercise in Participants With Asthma (0476-911) Completed Merck Sharp & Dohme Corp. Phase 3 2005-12-01 The purpose of this study is to determine the effect of four weeks of treatment with two investigational drugs (oral versus inhaled administration) plus an inhaled medication in the treatment of airway constriction brought on by exercise in participants with asthma.
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.
NCT00269126 ↗ Clinical Evaluation Of GW815SF For Chronic Obstructive Pulmonary Disease (Chronic Bronchitis, Emphysema) Completed GlaxoSmithKline Phase 3 2005-02-01 This study compares the effect of two medicines on COPD (Chronic Obstructive Pulmonary Disease). This study will last up to 18 weeks, and subjects will visit the clinic 5 times. Subjects will be given breathing tests, and will record their breathing symptoms daily on diary cards.
NCT00350207 ↗ Efficacy and Safety of Tiotropium and Salmeterol in Moderate Persistent Asthma Patients Homozygous for B16-Arg/Arg Completed Boehringer Ingelheim Phase 2 2006-07-01 This is a 16 week multicentre, multinational, randomised, double-blind, double-dummy, placebo-controlled, parallel group study to evaluate the long-term efficacy and safety of tiotropium compared to salmeterol in moderate persistent asthmatic (GINA step 3) patients homozygous for arginine at the 16th amino acid position of the beta-adrenergic receptor (ADRB2). Following an initial 4-week run-in period on salmeterol MDI patients will be randomised into the 16 week double-blind treatment period in which they receive either tiotropium once daily administered from the Respimat inhaler or salmeterol twice daily administered from the hydrofluoro-alkane Metered Dose Inhaler (MDI), or placebo twice daily. After the 16 week treatment period all patients will receive salmeterol MDI twice daily for four weeks. The patients perform daily morning and evening peak flow (PEF) and Forced Expiratory Volume in the First Second (FEV1) measurements with an electronic peak flow meter throughout the study. Daily data on asthma control and use of rescue medication are recorded using an electronic diary included in the electronic peak flow meter. On study visits the Mini-Asthma Quality of Life Questionnaire (Elizabeth Juniper) is administered, pulse and blood pressure and pre-dose pulmonary function testing (FEV1 and Forced Vital Capacity) are performed.
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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Salmeterol Xinafoate

Condition Name

Condition Name for Salmeterol Xinafoate
Intervention Trials
Asthma 21
Bioequivalence 11
Pulmonary Disease, Chronic Obstructive 10
Chronic Obstructive Pulmonary Disease 3
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Condition MeSH

Condition MeSH for Salmeterol Xinafoate
Intervention Trials
Asthma 23
Pulmonary Disease, Chronic Obstructive 15
Lung Diseases 15
Lung Diseases, Obstructive 13
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Clinical Trial Locations for Salmeterol Xinafoate

Trials by Country

Trials by Country for Salmeterol Xinafoate
Location Trials
United States 257
Greece 15
Germany 12
South Africa 10
Australia 9
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Trials by US State

Trials by US State for Salmeterol Xinafoate
Location Trials
California 13
Texas 13
Colorado 12
Missouri 12
North Carolina 11
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Clinical Trial Progress for Salmeterol Xinafoate

Clinical Trial Phase

Clinical Trial Phase for Salmeterol Xinafoate
Clinical Trial Phase Trials
Phase 4 8
Phase 3 11
Phase 2 10
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Clinical Trial Status

Clinical Trial Status for Salmeterol Xinafoate
Clinical Trial Phase Trials
Completed 47
Not yet recruiting 2
Active, not recruiting 2
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Clinical Trial Sponsors for Salmeterol Xinafoate

Sponsor Name

Sponsor Name for Salmeterol Xinafoate
Sponsor Trials
GlaxoSmithKline 14
Respirent Pharmaceuticals Co Ltd. 11
Becro Ltd. 11
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Sponsor Type

Sponsor Type for Salmeterol Xinafoate
Sponsor Trials
Industry 66
Other 11
NIH 3
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