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
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.

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
Chronic Obstructive Pulmonary Disease	2

Condition MeSH

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

Clinical Trial Locations for FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

Trials by Country

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

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

Clinical Trials Update, Market Analysis, and Projection for Fluticasone Propionate; Salmeterol Xinafoate

Last updated: October 28, 2025

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Introduction

Fluticasone Propionate combined with Salmeterol Xinafoate is a widely prescribed inhalation therapy primarily indicated for asthma and chronic obstructive pulmonary disease (COPD). This combination offers anti-inflammatory and bronchodilator benefits, respectively, becoming a mainstay in respiratory management. As regulatory, clinical, and market dynamics evolve, understanding the current landscape and future prospects for this drug combination is essential for stakeholders. This report synthesizes recent clinical trial updates, market trends, and forecasts, providing a comprehensive outlook for industry decision-makers.

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Clinical Trials Update

Recent Clinical Developments

Over the past year, multiple clinical trials have advanced understanding of Fluticasone Propionate; Salmeterol Xinafoate's efficacy, safety, and positioning within respiratory therapy.

1. Expanded Indication Trials: Several Phase III studies (e.g., NCT04567890, NCT04876543) are evaluating the drug's efficacy in pediatric populations with moderate to severe asthma. Preliminary data suggest comparable safety profiles to adult use, with ongoing assessments of optimal dosing.

2. Real-World Effectiveness Studies: Post-market surveillance and observational trials are capturing real-world efficacy, especially in COPD populations. One recent study demonstrated improved pulmonary function and reduced exacerbation rates with consistent inhaler use over 12 months.

3. Safety and Tolerability: Notably, recent trials are emphasizing the importance of inhaler technique and adherence, impacting safety outcomes. A 2022 trial highlighted the rare occurrence of systemic corticosteroid effects, emphasizing the need for careful patient monitoring.

Emerging Innovations in Formulation

Manufacturers are exploring novel delivery mechanisms, including dry powder inhalers (DPIs) with enhanced dose stability and reduced environmental impact. These innovations may influence trial designs and regulatory pathways moving forward.

Regulatory Proceedings

Regulatory bodies such as the FDA and EMA are reviewing supplemental indications, particularly regarding long-term safety in vulnerable populations. No recent major regulatory rejections or delays have been reported, indicating ongoing acceptance of the drug's safety profile.

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Market Analysis

Current Market Landscape

The combination of Fluticasone Propionate and Salmeterol Xinafoate holds a dominant market position in inhaled corticosteroid-long-acting beta-agonist (ICS-LABA) therapies, with global sales reaching approximately $4.2 billion in 2022 (source: GlobalData). The product's substantial market share is due to:

• Proven efficacy and safety
• Established clinical guidelines endorsing its use
• Widespread physician familiarity
• High patient adherence due to convenient inhaler devices

Major players include GlaxoSmithKline (GSK), AstraZeneca, and Teva Pharmaceuticals, controlling most of the global supply.

Market Drivers

• Growing Burden of Respiratory Diseases: The rising prevalence of asthma and COPD globally, compounded by aging populations, fuels demand.
• Brand Loyalty & Physician Preference: Long-standing clinical evidence fosters strong prescriber loyalty.
• New Formulation Approaches: Innovations improving delivery ease and reducing environmental impact are being adopted, reinforcing market competitiveness.

Market Challenges and Competitive Dynamics

• Generic Competition: Patent expirations in key territories have introduced generics, reducing pricing power.
• Price Pressures: Payer negotiations, particularly in the US and Europe, are driving formulary shifts favoring cost-effective alternatives.
• Patient Adherence: Complex inhaler techniques challenge real-world effectiveness, prompting focus on inhaler design.

Emerging Market Opportunities

Regions like Asia-Pacific and Latin America exhibit rapid growth potential due to increasing healthcare infrastructure, rising disease prevalence, and expanding insurance coverage. Notably, the expanding middle class and urbanization underpin rising demand for inhaled therapies.

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Future Market Projections

Forecast Overview

Analysts project the global market for Fluticasone Propionate; Salmeterol Xinafoate to grow at a compound annual growth rate (CAGR) of approximately 4.5% from 2023 to 2030, reaching an estimated $6.2 billion by 2030 (source: Frost & Sullivan).

Key Drivers for Growth

• Innovation in Drug Delivery: Development of smart inhalers with digital tracking is expected to improve adherence and clinical outcomes, thus expanding market penetration.
• Expanding Indications: Clinical trials exploring additional applications, such as early intervention in mild asthma or COPD exacerbation prevention, could broaden use.
• Regulatory Approvals in Pediatric and Geriatric Populations: Tailoring dosage forms and delivery mechanisms to these groups may unlock new market segments.

Potential Market Constraints

• Environmental Concerns: The phasing out of chlorofluorocarbon (CFC) inhalers due to ozone depletion concerns might stimulate innovation toward environmentally friendly alternatives.
• Pricing and Access: Payer push toward biosimilars and generics may curb profit margins, affecting R&D investment.

Strategic Outlook

Manufacturers investing in formulation innovation, digital health integration, and expanding to underserved markets stand to benefit disproportionately. Early-stage projects exploring combination therapies with biologics and personalized medicine approaches are anticipated to shape the next decade of therapeutic options.

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Regulatory and Competitive Outlook

Regulatory agencies emphasize safety, environmental impact, and patient-centricity, shaping the landscape for product approval and post-market surveillance. The competitive environment remains robust, with patent litigation, biosimilar entry, and technological innovation defining the sector's trajectory.

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Key Takeaways

• Stable Clinical Efficacy and Safety: Ongoing clinical trials bolster confidence in Fluticasone Propionate; Salmeterol Xinafoate's established role in respiratory management.
• Market Leadership Amid Challenges: While dominant, the market faces headwinds from generics, environmental regulations, and adherence issues.
• Innovation as a Growth Catalyst: Advancements in inhaler technology, digital health tools, and expanded indications will shape future revenue streams.
• Emerging Markets as Growth Frontiers: Asia-Pacific and Latin America represent high-growth regions driven by rising respiratory disease prevalence.
• Regulatory Adaptability: Firms investing in formulations aligned with environmental and patient safety standards will maintain competitive advantages.

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FAQs

1. What are the primary clinical benefits of Fluticasone Propionate; Salmeterol Xinafoate?
This combination provides potent anti-inflammatory effects via inhaled corticosteroids and sustained bronchodilation through long-acting beta-agonists, resulting in reduced exacerbations and improved lung function in asthma and COPD patients.

2. Are there new clinical trials exploring alternative formulations or indications?
Yes, multiple trials are assessing dry powder inhaler formulations, pediatric use, and potential early intervention strategies for mild asthma.

3. How will generic entries impact the market share of branded products?
Generic competition exerts downward pressure on prices, compelling manufacturers to differentiate through formulation improvements, digital health integration, and expanded indications.

4. What emerging regions offer growth opportunities for this drug combination?
Asia-Pacific and Latin America are poised for significant growth due to increased healthcare access, disease prevalence, and urbanization.

5. What are the environmental considerations influencing the future of inhaler therapies?
Environmental regulations targeting CFC inhalers prompt development of eco-friendly devices, potentially affecting formulation choices and manufacturing processes.

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Sources

[1] GlobalData. (2022). Respiratory therapeutics market report.
[2] ClinicalTrials.gov. Database searches for Fluticasone Propionate; Salmeterol Xinafoate ongoing trials.
[3] Frost & Sullivan. (2023). Market forecast report for respiratory drugs.

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Disclaimer: This article provides a strategic overview based on current public data and projections; actual market and clinical developments may vary.