CLINICAL TRIALS PROFILE FOR FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

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.

All Clinical Trials for FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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.
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.

Clinical Trial Conditions for FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

Condition Name

Condition Name for FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Intervention	Trials
Asthma	18
Bioequivalence	12
Pulmonary Disease, Chronic Obstructive	6
Respiratory Disorders	2

Condition MeSH

Condition MeSH for FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Intervention	Trials
Asthma	18
Lung Diseases	10
Pulmonary Disease, Chronic Obstructive	10
Lung Diseases, Obstructive	9

Clinical Trial Locations for FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

Trials by Country

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−

Trials by Country for FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Location	Trials
United States	195
Greece	13
Germany	10
Canada	8
South Africa	8

Trials by US State

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−

Trials by US State for FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Location	Trials
Texas	9
Florida	8
Colorado	8
California	8
North Carolina	8

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	7
Phase 2	6

Clinical Trial Status

Clinical Trial Status for FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Clinical Trial Phase	Trials
Completed	35
Not yet recruiting	4
Active, not recruiting	2

Clinical Trial Sponsors for FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

Sponsor Name

Sponsor Name for FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Sponsor	Trials
GlaxoSmithKline	13
Becro Ltd.	12
Respirent Pharmaceuticals Co Ltd.	12

Sponsor Type

Sponsor Type for FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Sponsor	Trials
Industry	56
Other	7
NIH	1

Fluticasone Propionate and Salmeterol Xinafoate: Clinical Trials, Market Analysis, and Projections

Introduction

Fluticasone propionate and salmeterol xinafoate are two medications commonly combined to treat respiratory conditions such as asthma and chronic obstructive pulmonary disease (COPD). This article delves into the clinical trials, market analysis, and future projections for this combination therapy.

Clinical Trials Overview

Survival and Efficacy in COPD

A significant clinical trial published in 2007 compared the combination of salmeterol (50 microg) and fluticasone propionate (500 microg) twice daily with placebo, salmeterol alone, or fluticasone propionate alone in patients with COPD. The trial involved 6112 patients over a period of 3 years. The results showed that the combination therapy reduced all-cause mortality rates, although not to a statistically significant level. However, it significantly reduced the annual rate of exacerbations and improved health status and spirometric values compared to the placebo group[1].

Safety and Efficacy in Asthma

Studies conducted by GSK, including the AUSTRI and VESTRI trials, compared the combination of fluticasone propionate and salmeterol (FSC) with fluticasone propionate (FP) alone in patients with asthma. These trials found no excess risk associated with salmeterol when used in combination with FP in both adolescent and adult patients, as well as children aged 4-11 years. The combination therapy did not increase the risk of asthma-related events such as death, intubations, or hospitalizations[3].

Efficacy in Children with Asthma

A meta-analysis of clinical trials involving children with asthma who required step-up treatment showed that the combination of fluticasone propionate and salmeterol (FSC) was more effective in reducing asthma exacerbations and improving lung function compared to FP alone, especially when the treatment duration exceeded 12 weeks. There were no significant differences in drug-related adverse events between FSC and FP alone[4].

Market Analysis

Market Size and Growth

The salmeterol market, which includes the combination therapy with fluticasone propionate, is projected to grow significantly. By 2027, the market is estimated to reach $615 million, growing at a CAGR of 3.82% from 2022 to 2027. This growth is driven by increasing cases of asthma and COPD, as well as the long-lasting effects of salmeterol[2].

Geographical Distribution

North America held a dominant market share of 36% in 2021, primarily due to the ready availability of the drug, high medical literacy, and significant budget allocations by pharmaceutical companies. However, the Asia-Pacific region is expected to offer lucrative growth opportunities due to increasing pollution levels and a growing incidence of respiratory diseases[2].

Distribution Channels

The market is segmented into offline and online distribution channels. Online channels are gaining traction due to better pricing and convenience. For example, the combination drug Seroflo 250 Rotacap, containing salmeterol and fluticasone propionate, can be obtained at a lower cost through online medical support sites compared to offline purchases[2].

Market Drivers

Environmental Factors

Deteriorating environmental factors, such as high levels of air pollution, are key drivers for the market growth. Regions like China, with air pollution levels significantly exceeding WHO limits, contribute to the increasing demand for respiratory medications[2].

Increasing Prevalence of Respiratory Diseases

The rising incidence of asthma and COPD, exacerbated by factors like industrial dust, chemical fumes, and tobacco smoking, drives the demand for inhalation and nasal spray drugs. The combination of fluticasone propionate and salmeterol is particularly favored due to its efficacy in reducing symptoms and improving lung function[5].

Combination Therapy Benefits

The combination of fluticasone propionate (a corticosteroid) and salmeterol (a long-acting beta-agonist) offers several benefits, including reduced side effects, lower costs, better compliance, and improved medication concordance. These factors contribute to the growth of the combination drugs segment in the market[5].

Market Restraints

Side Effects and Adverse Events

While the combination therapy is generally well-tolerated, there are some side effects and adverse events to consider. For instance, the incidence of pneumonia is higher among patients receiving medications containing fluticasone propionate compared to those on placebo[1].

Regulatory Considerations

Regulatory updates and safety reviews can impact the market. For example, the FDA approved label updates for ICS/LABA combinations based on safety data, which can influence prescribing practices and market dynamics[3].

Future Projections

Global Market Growth

The global market for inhalation and nasal spray drugs, including the combination of fluticasone propionate and salmeterol, is expected to reach $65.3 billion by 2031, growing at a CAGR of 6.5%. The Asia-Pacific region is anticipated to expand at the fastest rate due to a large target population and government support for healthcare initiatives[5].

Emerging Markets

Emerging markets, particularly in the Asia-Pacific region, will play a crucial role in the future growth of the salmeterol market. Factors such as increasing FDI in the pharmaceutical sector and government schemes to improve healthcare access will drive market expansion[2].

Key Takeaways

• Clinical Efficacy: The combination of fluticasone propionate and salmeterol has been shown to reduce exacerbations and improve lung function in patients with asthma and COPD.
• Market Growth: The salmeterol market is projected to grow at a CAGR of 3.82% from 2022 to 2027, driven by increasing cases of respiratory diseases and favorable environmental factors.
• Geographical Trends: North America currently dominates the market, but the Asia-Pacific region is expected to offer significant growth opportunities.
• Distribution Channels: Online channels are becoming increasingly important due to better pricing and convenience.
• Market Drivers: Deteriorating environmental factors and the increasing prevalence of respiratory diseases are key drivers for market growth.

FAQs

What is the primary use of the combination therapy of fluticasone propionate and salmeterol?

The primary use is to treat respiratory conditions such as asthma and COPD by reducing symptoms like shortness of breath, wheezing, and coughing.

What are the key benefits of the combination therapy?

The combination reduces side effects, lowers costs, improves compliance, and enhances medication concordance compared to monotherapy.

Which region is expected to drive the future growth of the salmeterol market?

The Asia-Pacific region is anticipated to drive future growth due to increasing pollution levels, a large target population, and government healthcare initiatives.

What are the potential side effects of the combination therapy?

Potential side effects include a higher incidence of pneumonia among patients receiving medications containing fluticasone propionate.

How does the combination therapy compare to monotherapy in clinical trials?

Clinical trials have shown that the combination therapy is more effective in reducing asthma exacerbations and improving lung function compared to monotherapy with fluticasone propionate alone.

Sources

1. Calverley, P. M., et al. "Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease." The New England Journal of Medicine, vol. 356, no. 8, 2007, pp. 775-789.
2. IndustryARC. "Salmeterol Market Share, Size and Industry Growth Analysis 2022-2027."
3. GSK. "FDA approves US label update on ICS/LABA combinations in asthma based on review of safety data."
4. PubMed. "Efficacy and safety of fluticasone propionate/salmeterol in children with asthma: a systematic review and meta-analysis."
5. iHealthcareAnalyst. "Global Inhalation and Nasal Spray Drugs Market $65.3 Billion by 2031."