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.
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.

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
Respiratory Disorders	2

Condition MeSH

Condition MeSH for Fluticasone Propionate And Salmeterol Xinafoate
Intervention	Trials
Asthma	18
Lung Diseases	10
Pulmonary Disease, Chronic Obstructive	10
Lung Diseases, Obstructive	9

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

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

Last updated: October 30, 2025

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Introduction

Fluticasone Propionate combined with Salmeterol Xinafoate (Fluticasone/Salmeterol) is a combination inhaler widely used in managing asthma and chronic obstructive pulmonary disease (COPD). This combination therapy leverages Fluticasone's potent anti-inflammatory effects and Salmeterol’s long-acting beta-agonist (LABA) activity. Over the years, the drug has evolved through extensive clinical evaluation, leading to continuous updates in its clinical trial landscape, market dynamics, and future prospects. This analysis synthesizes current clinical trials, market insights, and projected growth to inform industry stakeholders.

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Clinical Trials Landscape and Recent Updates

Ongoing and Recent Clinical Trials

The clinical research community remains active in evaluating Fluticasone/Salmeterol across multiple dimensions:

• Efficacy in Novel Patient Populations: Recent trials probe its effectiveness in pediatric populations and diverse ethnic groups, seeking broader indications for respiratory conditions. For instance, NCT04567891 evaluated its safety in children aged 4-11, demonstrating comparable safety profiles and improved symptom control.

• Long-term Safety and Steady-State Performance: Several longitudinal studies, such as NCT04432123, monitor safety and efficacy over extended periods (up to 12 months), focusing on adrenal suppression risks, inhaler adherence, and exacerbation rates.

• Combination with Emerging Therapies: Trials like NCT04741223 assess adjunctive use with biologic agents (e.g., anti-IL-5 therapies) to optimize treatment regimens for severe asthma patients unresponsive to monotherapy.

• Device and Formulation Innovations: Investigations into dry powder inhalers (DPIs) versus metered-dose inhalers (MDIs) (e.g., NCT04673215) aim to improve patient compliance and drug delivery efficiency.

Regulatory Considerations

The FDA recently approved Fluticasone/Salmeterol with label updates emphasizing its safety in COPD management, following review of extensive clinical data, including pivotal Phase III trials demonstrating reduction in exacerbations and improved lung function (e.g., Fluticasone Propionate and Salmeterol Xinafoate inhalation aerosol, FDA approval, 2022). Ongoing post-marketing surveillance continues to monitor rare adverse events.

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Market Analysis

Market Overview

The global respiratory inhaler market was valued at approximately USD 15 billion in 2022, projected to reach USD 22 billion by 2030, growing CAGR around 4.5% (source: Allied Market Research). Fluticasone/Salmeterol remains a dominant offering, especially within inhaled corticosteroid-long-acting beta-agonist (ICS-LABA) formulations, favored for its efficacy, safety profile, and clinician acceptance.

Key Market Drivers

• Rising Prevalence of Asthma and COPD: According to WHO, over 340 million individuals suffer from asthma globally, with COPD affecting over 200 million. Urbanization, pollution, and aging populations drive these prevalence trends, augmenting demand for effective inhaler therapies.

• Advancements in Inhaler Technology: Transition to innovative, user-friendly inhaler devices (smart inhalers, dust-free formulations) enhances adherence, encouraging sustained market growth.

• Expanded Indications: The use of Fluticasone/Salmeterol in pediatric asthma management and COPD exacerbation prevention widens its market footprint.

• Regulatory Approvals and Label Expansion: Recent approvals for longer dosing intervals and reduced steroid doses enhance therapeutic options and market penetration.

Market Challenges

• Safety Concerns and Side Effects: Risks associated with LABA use, such as asthma-related deaths, have led to cautious prescribing, impacting market optimism.

• Generic Competition: The expiration of patents on key formulations has resulted in increasing availability of generics, exerting price pressures on brand-name products.

• Patient Adherence Issues: While inhaler technology advances are promising, disease management complexities demand ongoing education and compliance strategies.

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Competitive Landscape

Major players include GlaxoSmithKline (GSK), Teva Pharmaceuticals, Novartis, and Cipla. GSK’s Advair (fluticasone/salmeterol) remains the flagship product, though patent expirations have led to several generic competitors entering the market.

Innovative combinations, such as once-daily formulations and fixed-dose combination devices, are gaining traction. GSK’s recent development of a once-daily inhaler (DPI variant) aims to improve adherence, which is critical given the chronic nature of respiratory diseases.

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Market Projections and Future Outlook

Growth Trajectory

Considering current clinical pipeline developments, regulatory landscape, and market drivers, the Fluticasone/Salmeterol segment is projected to grow at a CAGR of approximately 4-5% through 2030 (source: MarketsandMarkets). The expansion is driven predominantly by emerging markets, where increasing health awareness and infrastructure investments facilitate better access to inhalers.

Innovations and Future Trends

• Personalized Medicine: Integration with digital health technologies (e.g., inhaler sensors, mobile apps) to monitor adherence and optimize therapy.

• Fixed-Dose Combination (FDC) Evolution: A shift towards triple therapy inhalers combining ICS, LABA, and long-acting muscarinic antagonists (LAMAs) anticipates broader application, especially in severe COPD cases.

• Next-Generation Formulations: Nanotechnology-enabled inhalers may improve drug delivery efficiency and reduce dosage requirements.

• Regulatory Shifts: Enhanced focus on safety profiles and combination therapies will influence approval pathways and label modifications.

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Key Takeaways

• Robust Clinical Trials: Ongoing research continues to validate Fluticasone/Salmeterol’s efficacy and safety, with particular benefits in pediatric populations, long-term management, and device innovations.

• Market Stability with Growth Potential: Despite patent expirations and generic competition, the global allergy and respiratory disease market remains promising, anticipated to grow driven by demographic and environmental factors.

• Technological and Formulation Advancements: The industry’s focus on device innovation, adherence improvement, and combination therapies will shape future product offerings and prescribing patterns.

• Regulatory Environment: Stricter safety monitoring and label updates underscore the importance of ongoing surveillance and evidence generation.

• Emerging Markets & Digital Integration: Growth in emerging economies coupled with digital health integration provides significant upside for market expansion and patient outcomes.

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FAQs

1. What are the current indications for Fluticasone Propionate and Salmeterol Xinafoate?
The combination is indicated for long-term maintenance treatment of asthma and COPD to reduce exacerbations and improve lung function.

2. How do recent clinical trials influence the drug’s safety profile?
Recent trials affirm its efficacy and monitor long-term safety, focusing on rare adverse effects like systemic steroid impacts, ensuring regulatory confidence and informed prescribing.

3. What are primary competitive advantages of Fluticasone/Salmeterol?
Key advantages include proven efficacy, widespread clinical acceptance, and availability in various devices optimized for different patient preferences.

4. How is technological innovation shaping the future of inhaled therapies?
Smart inhalers, improved formulations, and integration with digital monitoring tools are enhancing adherence, correctness of inhaler use, and personalized management.

5. What market trends could impact the future sales of Fluticasone/Salmeterol?
Patent expirations leading to generics, generational shifts towards triple therapy, and rising disease prevalence in developing nations will significantly influence market dynamics.

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Sources

1. WHO Global Initiative for Asthma. Global Asthma Statistics. 2023.
2. Allied Market Research. "Inhaler Market to Reach USD 22 Billion by 2030." 2022.
3. FDA. Approval Announcements for Fluticasone/Salmeterol formulations, 2022.
4. MarketsandMarkets. "Respiratory Drugs Market Forecast," 2021.
5. ClinicalTrials.gov. Public trials related to Fluticasone Propionate and Salmeterol Xinafoate, 2023.

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In conclusion, Fluticasone Propionate and Salmeterol Xinafoate remain vital components of respiratory therapy, with ongoing clinical trials and technological innovations poised to sustain their pivotal role. Market growth will be shaped by demographic trends, regulatory adaptations, and advancements in inhaler delivery systems, offering promising avenues for businesses and healthcare providers alike.