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.
NCT00527826 ↗	Influence Of Salmeterol Xinafoate/Fluticasone Propionate (50/500 µg BID) On The Course Of The Disease And Exacerbation Frequency In COPD Patients Gold Stage III And IV	Completed	GlaxoSmithKline	Phase 4	2007-11-01	This is a 12 month randomized, open-label, parallel-group study to obtain data on the frequency and variability of exacerbations in severe and very severe Chronic Obstructive Pulmonary Disease (COPD) patients (Global Initiative for Chronic Obstructive Lung Disease (GOLD) Stage III and IV) receiving salmeterol xinafoate and fluticasone propionate either in fixed combination (SFC) or from separate inhalers (Sal/FP) with standard therapy. 200 subjects will be enrolled in approximately 30 study centres in Germany. Data on health care utilisation will be collected to compare direct costs associated with COPD in these two groups. Baseline data will be collected for all subjects at Visit 1 and eligible subjects will be randomized to receive either SFC 50/500 µg bid (twice daily) as fixed combination or Sal 50 µg bid (twice daily) and FP 500 µg bid (twice daily) concurrently over 52 weeks. Subjects will return for study visits every two to three months until week 52. Additional telephone calls will be made between scheduled visits every 4 weeks. Assessments will include monitoring of frequency of exacerbations, health care utilisation (including emergency visits and hospitalizations) and rescue medication, lung function, drug compliance, health-related quality of life (SGRQ = St George's Respiratory Questionnaire) and safety.

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
Chronic Obstructive Pulmonary Disease	2

Condition MeSH

Condition MeSH for FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE
Intervention	Trials
Asthma	18
Pulmonary Disease, Chronic Obstructive	10
Lung Diseases	10
Respiratory Aspiration	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
Florida	8
Colorado	8
California	8
North Carolina	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

Last updated: May 1, 2026

Clinical Trials Update, Market Analysis and Projection for Fluticasone Propionate and Salmeterol Xinafoate (Combination Inhaled Therapy)

What is the product and how is it positioned?

Fluticasone propionate + salmeterol xinafoate is a fixed-dose inhaled combination of:

• Fluticasone propionate (FP): inhaled corticosteroid (ICS) for anti-inflammatory control
• Salmeterol xinafoate (SAL): long-acting beta2-agonist (LABA) for bronchodilation and symptom prevention

Regulatory status (high-level): Multiple branded and generic versions exist across major markets, with formulations delivered via inhalers (e.g., MDI and DPI depending on brand and jurisdiction). The market is mature and dominated by long-standing products.

Market role: Inhaled ICS/LABA combinations are standard-of-care for persistent asthma and COPD patients not adequately controlled on monotherapy.

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What do current clinical trials indicate by program theme?

A complete, up-to-the-minute global trial registry audit cannot be produced from the information provided in the prompt. Under the operational constraints, no partial trial listing should be generated.

That said, clinical activity for this class typically concentrates on:

• Line extensions (different strengths, delivery devices, or formulation changes)
• Comparative effectiveness versus other ICS/LABA combinations
• Safety and real-world effectiveness in asthma and COPD cohorts
• Pediatric or geriatric subgroup evaluations where label-expansion is pursued

Practical read-through for investors and R&D strategists: For mature ICS/LABA fixed-dose combinations, trial value tends to come from device/particle engineering, dosing regimen optimization, and adherence-focused studies, not from fundamentally new MoA.

(If you need the trial-by-trial update, it requires pulling from a specific registry dataset and brand/formulation mapping.)

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How large is the market and what drives it?

Where does demand concentrate?

Demand for FP/SAL is driven by:

• Asthma prevalence and chronic disease management patterns
• COPD prevalence and escalation to ICS/LABA in exacerbation-prone or eosinophilic phenotypes
• Treatment guidelines that favor combination therapy when monotherapy is insufficient
• Switching dynamics: patients and payers often maintain ICS/LABA regimens that are tolerable, covered, and effective, which supports ongoing unit volumes even as generics expand

Commercial structure

For many mature ICS/LABA fixed combinations:

• Brand share declines over time as patents and exclusivities expire
• Generics and authorized generics expand, compressing net pricing
• Differentiation shifts to device usability, inhaler technique support programs, and contracting

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What is the pricing and margin outlook under genericization?

For established FP/SAL products:

• Wholesale acquisition cost and payer net prices typically face downward pressure after key exclusivities lapse and generic entry increases
• Inhaler device competition (DPI vs MDI formats) can preserve some share, but price convergence is common

Business implication: The market becomes more about volume stability and contract wins than premium pricing.

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Market projection: what trajectory is most likely?

Base case: modest growth in units, soft growth or decline in revenues

For mature fixed-dose ICS/LABA combinations, market value growth usually reflects:

• Unit growth tied to population, persistence, and guideline-based adoption
• Revenue softness driven by generic price pressure

A robust projection requires current market size by geography, product type, and formulation, which is not provided in the prompt. Under the constraints, no numeric forecasting should be fabricated.

What can be stated without inventing numbers: the market trajectory for FP/SAL combinations is typically characterized by:

• Sustained demand due to chronic use
• Net revenue compression from generic and authorized generic penetration
• Share shifts driven by device experience and payer formulary design

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Competitive landscape: who matters commercially?

What drug classes compete most directly?

FP/SAL is competed against by:

• Other ICS/LABA fixed-dose combinations (e.g., budesonide/formoterol, fluticasone/vilanterol, mometasone/formoterol, etc.)
• LABA/LAMA and triple therapy regimens for COPD (ICS/LABA/LAMA) when patients escalate
• Alternative delivery devices and payer-preferred inhalers

How do payers typically choose?

Payer selection is usually driven by:

• Contract pricing and rebates
• Formulary tier placement
• Demonstrated usability and adherence performance (particularly for DPI)
• Prior authorization requirements and step therapy rules

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Strategic implications for R&D and investment

Where can value still be created?

Even for a mature combination, new value can emerge through:

• Device-level differentiation (dose consistency, plume, dose counter reliability, user error reduction)
• Differentiated strengths or pediatric-friendly dosing that simplify prescribing
• Demonstrating superior real-world adherence and reducing exacerbations as a cost-offset narrative for payers
• Targeted post-approval studies aligned to payer endpoints (exacerbation rates, hospitalization reduction, adherence persistence)

Where value is usually constrained

• If differentiation is only formulation-level without clinical outcome advantages, trials often struggle to justify premium pricing
• In high-genericization markets, clinical studies must connect to payer-relevant endpoints quickly to matter commercially

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Key Takeaways

• Fluticasone propionate + salmeterol xinafoate is a mature ICS/LABA inhaled combination used in asthma and COPD management, with demand supported by chronic use and guideline escalation patterns.
• Class-level clinical development typically focuses on formulation/device line extensions and real-world effectiveness rather than new MoA breakthroughs.
• Market economics for established ICS/LABA combinations typically show stable unit demand but revenue pressure from generic and authorized generic penetration.
• Growth projections for the combination depend on regional market size, formulary dynamics, and device mix, which are not provided in the prompt; no numeric forecasts are produced here.

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FAQs

1) What is the mechanism of action for fluticasone propionate and salmeterol xinafoate?

Fluticasone is an inhaled corticosteroid that reduces airway inflammation, while salmeterol is a long-acting beta2-agonist that provides bronchodilation and symptom prevention.

2) Is fluticasone propionate plus salmeterol used for asthma, COPD, or both?

It is used for both, aligned to standard-of-care escalation to ICS/LABA combinations when monotherapy is inadequate.

3) Why does the market for this combination usually face revenue pressure over time?

Because mature ICS/LABA fixed-dose products experience pricing declines as generic and authorized generic competition increases and payer contracting tightens.

4) What types of clinical studies are most common for mature ICS/LABA fixed-dose combinations?

Device and formulation line extensions, comparative effectiveness evaluations, and real-world effectiveness or safety studies in asthma and COPD populations.

5) What are the biggest differentiators that still matter commercially?

Inhaler usability, dose delivery consistency, adherence support, and evidence tied to payer-relevant outcomes like exacerbation reduction.

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References

[1] Food and Drug Administration (FDA). Drug labeling information for fluticasone and salmeterol-containing products (accessed via FDA label database). https://www.accessdata.fda.gov/scripts/cder/daf/
[2] European Medicines Agency (EMA). EPARs and product information for fluticasone/salmeterol combinations (accessed via EMA medicines database). https://www.ema.europa.eu/en/medicines
[3] Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention (most recent version available). https://ginasthma.org/
[4] Global Initiative for Chronic Obstructive Lung Disease (GOLD). 2025 Global Strategy for the Diagnosis, Management, and Prevention of COPD. https://goldcopd.org/
[5] World Health Organization (WHO). Asthma and COPD facts and burden summaries (accessed via WHO health topics pages). https://www.who.int/health-topics/asthma and https://www.who.int/health-topics/chronic-obstructive-pulmonary-disease