CLINICAL TRIALS PROFILE FOR FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE

505(b)(2) Clinical Trials for Fluticasone Propionate And 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 And 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.

Clinical Trial Conditions for Fluticasone Propionate And Salmeterol Xinafoate

Condition Name

Condition Name for Fluticasone Propionate And Salmeterol Xinafoate
Intervention	Trials
Asthma	18
Bioequivalence	12
Pulmonary Disease, Chronic Obstructive	6

Condition MeSH

Condition MeSH for Fluticasone Propionate And Salmeterol Xinafoate
Intervention	Trials
Asthma	18
Pulmonary Disease, Chronic Obstructive	10
Lung Diseases	10

Clinical Trial Locations for Fluticasone Propionate And Salmeterol Xinafoate

Trials by Country

Trials by Country for Fluticasone Propionate And Salmeterol Xinafoate
Location	Trials
United States	195
Greece	13
Germany	10
Canada	8
South Africa	8

Trials by US State

Trials by US State for Fluticasone Propionate And Salmeterol Xinafoate
Location	Trials
Texas	9
North Carolina	8
Missouri	8
Florida	8
Colorado	8

Clinical Trial Progress for Fluticasone Propionate And Salmeterol Xinafoate

Clinical Trial Phase

Clinical Trial Phase for Fluticasone Propionate And Salmeterol Xinafoate
Clinical Trial Phase	Trials
Phase 4	6
Phase 3	7
Phase 2	6

Clinical Trial Status

Clinical Trial Status for Fluticasone Propionate And Salmeterol Xinafoate
Clinical Trial Phase	Trials
Completed	35
Not yet recruiting	4
Active, not recruiting	2

Clinical Trial Sponsors for Fluticasone Propionate And Salmeterol Xinafoate

Sponsor Name

Sponsor Name for Fluticasone Propionate And Salmeterol Xinafoate
Sponsor	Trials
GlaxoSmithKline	13
Becro Ltd.	12
Respirent Pharmaceuticals Co Ltd.	12

Sponsor Type

Sponsor Type for Fluticasone Propionate And Salmeterol Xinafoate
Sponsor	Trials
Industry	56
Other	7
NIH	1

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

Last updated: January 9, 2025

Introduction

Fluticasone propionate and salmeterol xinafoate is a combination drug widely used for the treatment of asthma and chronic obstructive pulmonary disease (COPD). This article provides an update on the clinical trials, market analysis, and projections for this drug combination.

Clinical Trials and Safety Data

Recent Studies

Clinical trials have been instrumental in establishing the safety and efficacy of fluticasone propionate and salmeterol xinafoate. Two significant safety studies, AUSTRI and VESTRI, conducted by GSK, compared the combination of fluticasone propionate and salmeterol (FSC) with fluticasone propionate (FP) alone. These studies found no excess risk associated with salmeterol when used in combination with fluticasone propionate for treating asthma in both adolescents, adults, and children aged 4-11 years[3].

Methodology and Outcomes

In these studies, patients were randomized to either FSC or FP and were assessed over a six-month period. The composite endpoint of asthma-related events (death, intubations, or hospitalizations) showed no significant difference between the two groups. This data supported the FDA's approval of the label update for ICS/LABA combinations in asthma, reinforcing the safety profile of this drug combination[3].

Mechanism of Action

Fluticasone Propionate

Fluticasone propionate is a corticosteroid that works by preventing certain cells in the lungs and breathing passages from releasing substances that cause asthma symptoms. It reduces swelling in the airways, making it easier to breathe[4].

Salmeterol Xinafoate

Salmeterol xinafoate is a long-acting beta-2 adrenergic receptor agonist (LABA) that relaxes and opens air passages in the lungs, providing long-lasting relief from bronchospasm. It works synergistically with fluticasone propionate to enhance the therapeutic effect[4].

Market Analysis

Market Size and Growth

The salmeterol market, which includes the combination of fluticasone propionate and salmeterol, is projected to grow significantly. By 2027, the market size 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 Segmentation

Geographically, North America held a dominant market share of 36% in 2021, due to the ready availability of the drug, high medical literacy, and a supportive healthcare budget. However, the Asia-Pacific region is expected to offer lucrative growth opportunities due to increasing pollution levels and a growing pharmaceutical sector[2].

Distribution Channels

The market is segmented by distribution channels into offline and online. Online channels are gaining traction due to cost savings 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].

Therapeutic Applications

Asthma

Fluticasone propionate and salmeterol xinafoate are used to control symptoms of asthma, particularly in patients whose condition is not adequately controlled by other asthma medications. This combination is not used to relieve an asthma attack that has already started but is used as a preventive measure[4].

COPD

The combination is also used to treat air flow blockage and reduce the worsening of COPD, including chronic bronchitis and emphysema. It helps in managing symptoms such as shortness of breath, coughing, and chest tightness[4].

Dosage and Administration

Inhalation Dosage

The drug is administered via inhalation using a special inhaler, such as the Advair Diskus or AirDuo Respiclick. The typical dosage for adults and children 12 years and older is one inhalation twice daily, with doses at least 12 hours apart. For children aged 4-11 years, the dosage is adjusted accordingly, and for those under 4 years, the dose must be determined by a doctor[4].

Market Drivers and Challenges

Market Drivers

• Increasing Prevalence of Asthma and COPD: The rising cases of asthma and COPD are significant drivers for the market.
• Environmental Factors: Deteriorating environmental conditions, such as air pollution, contribute to the growth of the market.
• Long-Lasting Effects: The long-lasting therapeutic effects of salmeterol make it a preferred treatment option[2].

Market Challenges

• Side Effects and Adverse Reactions: Despite the overall safety profile, some patients may experience side effects or adverse reactions, which can hamper market growth.
• Regulatory Scrutiny: Continuous regulatory scrutiny and the need for ongoing safety data can pose challenges for market expansion[2].

Global Market for Inhalation Drugs

Market Size and Growth

The global market for inhalation and nasal spray drugs, which includes the combination of fluticasone propionate and salmeterol, is estimated to reach $65.3 billion by 2031, growing at a CAGR of 6.5% over the forecast period. Factors contributing to this growth include reduced side effects, lower costs, better compliance, and improved medication concordance[5].

Key Takeaways

• Clinical Trials: Recent studies have reinforced the safety and efficacy of the combination of fluticasone propionate and salmeterol.
• Market Growth: The market is projected to grow significantly, driven by increasing cases of asthma and COPD, and favorable environmental factors.
• Geographical Segmentation: North America currently dominates the market, but the Asia-Pacific region is expected to offer significant growth opportunities.
• Therapeutic Applications: The drug combination is crucial for managing asthma and COPD symptoms.
• Dosage and Administration: Proper use and dosage are critical for effective treatment and minimizing side effects.

FAQs

What are the primary therapeutic applications of fluticasone propionate and salmeterol xinafoate?

The primary therapeutic applications are for the treatment of asthma and chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema[4].

How is the drug administered?

The drug is administered via inhalation using a special inhaler, such as the Advair Diskus or AirDuo Respiclick[4].

What are the key market drivers for this drug combination?

The key market drivers include the increasing prevalence of asthma and COPD, deteriorating environmental factors, and the long-lasting therapeutic effects of salmeterol[2].

What are the potential side effects of fluticasone propionate and salmeterol xinafoate?

While generally safe, potential side effects include liver function impairment, especially in patients with pre-existing liver conditions, and age-related health issues in elderly patients[3][4].

How does the combination of fluticasone propionate and salmeterol work?

Fluticasone propionate reduces swelling in the airways, while salmeterol xinafoate relaxes and opens air passages in the lungs, providing synergistic relief from asthma and COPD symptoms[4].

Sources

1. Patsnap Synapse - Fluticasone propionate/Salmeterol xinafoate.
2. Industry ARC - Salmeterol Market Share, Size and Industry Growth Analysis 2022.
3. GSK - FDA approves US label update on ICS/LABA combinations in asthma.
4. Mayo Clinic - Fluticasone and salmeterol (inhalation route).
5. iHealthcareAnalyst - Global Inhalation and Nasal Spray Drugs Market.