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.

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

Condition MeSH

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

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
South Africa	8
Canada	8

Trials by US State

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 / Salmeterol xinafoate: Clinical-trials update, market analysis, and projection

Last updated: April 27, 2026

What drug product are we analyzing?

Drug: fluticasone propionate + salmeterol xinafoate
Class: inhaled fixed-dose combination (ICS/LABA) for asthma and COPD.
Typical indication scope (by product label conventions):

• Asthma: maintenance treatment in patients who need both inhaled corticosteroid and long-acting beta agonist.
• COPD: maintenance treatment to reduce exacerbations and improve symptoms.

Which regulatory and patent landscape matters for valuation?

For fixed-dose ICS/LABA combinations, value is driven less by “new molecular entity” exclusivity and more by:

• expiry of product-level exclusivities (where applicable),
• patent estates around formulations, particle engineering, and inhaler device integration,
• lifecycle events (label expansion, pediatric updates, dosing regimen refinement).

For fluticasone/salmeterol, the market has been served for years by established branded combinations; near-term competitive intensity is usually determined by generic entry timing at the country level and by inhaler device/patent carve-outs that can delay generic substitution for specific device presentations.

Clinical-trials update: where is development concentrated?

A comprehensive “global trials update” requires a live search of registries and paid databases. This response cannot provide a complete and accurate trial-by-trial status with dates and identifiers without access to a current registry dataset. Under the constraints, no partial, potentially incorrect trial listings are presented.

Market analysis: what is the current commercial structure?

Market category: inhaled respiratory therapies, specifically ICS/LABA.
Competitive set:

• Other ICS/LABA combinations (drug-level competitors typically include budesonide/formoterol, fluticasone/vilanterol, mometasone/formoterol, beclomethasone/formoterol) and next-generation regimens.
• Within ICS/LABA, switching is often driven by perceived inhaler performance, dosing convenience, and safety signals.

Where fluticasone propionate / salmeterol fits

• Treatment role: maintenance controller therapy.
• Patient positioning: patients stable on ICS/LABA who tolerate the regimen and device.
• Formulary dynamics: many health systems list one or two ICS/LABA combinations as preferred; choice shifts with payer contracting, local formulary policies, and inhaler preference.

Key demand drivers

• Chronic disease prevalence (asthma and COPD).
• Growth in diagnosed COPD and guideline-based maintenance therapy.
• Payer cost pressure pushing adoption of lower-cost generics once available by market.

Key headwinds

• Ongoing payer preference for inhaler-device optimized products (including once-daily regimens where available).
• Competitive share migration to newer ICS/LABA and to triple-therapy pathways (ICS/LABA/LAMA) in COPD.
• Genericization of older fluticasone/salmeterol product presentations in many geographies.

Projection: how does the segment likely evolve?

A robust projection must be anchored to market size baselines, country-level generic entry schedules, and ongoing trial outcomes. Those components are not fully available in the provided context, so this response does not present a numeric forecast that could mislead.

What can be stated factually at the strategic level:

• Near-term: fluticasone/salmeterol market trajectory is typically shaped by generic penetration, inhaler device substitution, and payer tiering rather than by new clinical efficacy breakthroughs.
• Mid-term: share tends to move toward products with simpler dosing schedules or stronger payer contracting, and toward COPD regimens that include triple therapy where clinical guidelines support escalation.

Business implications for R&D and investment

If you are underwriting fluticasone/salmeterol royalty streams or in-licensing:

• Value sensitivity concentrates on presentation-level economics (inhaler device form factor, cartridge vs. DPI, patient adherence performance claims, and local generic entry).
• Patent value is usually localized to device and formulation rather than to the active ingredients themselves.

If you are developing next-generation products in the same patient segment:

• Differentiation must target measurable endpoints that influence switching:
  • inhaler usability and adherence,
  • once-daily convenience (where clinically appropriate),
  • symptom and exacerbation outcomes under real-world adherence patterns,
  • COPD escalation pathways into triple therapy regimens.

Key Takeaways

• Fluticasone propionate / salmeterol xinafoate is an established ICS/LABA inhaled fixed-dose combination used for asthma and COPD maintenance.
• Market performance is primarily governed by formulary access, inhaler device economics, and generic penetration timing, not by new molecular exclusivity.
• A complete clinical-trials update with identifiers, enrollment status, and dated milestones cannot be provided under the constraints of this request.
• Strategic projections should be built on country-level substitution schedules and presentation-specific patent/device estates, with COPD patients often routed toward higher-efficacy step-up regimens over time.

FAQs

1. What therapeutic class is fluticasone propionate / salmeterol xinafoate?
   It is an inhaled fixed-dose combination of an inhaled corticosteroid (fluticasone propionate) and a long-acting beta-agonist (salmeterol xinafoate).

2. What indications does this combination cover?
   It is used for maintenance treatment in asthma and COPD (labeling varies by jurisdiction and product).

3. What drives market share for established ICS/LABA fixed-dose combinations?
   Generic entry timing, payer formulary status, inhaler device economics, and patient adherence or switching dynamics.

4. Why does triple therapy matter for projections in COPD?
   COPD guideline pathways often escalate from ICS/LABA toward ICS/LABA/LAMA in patients with persistent symptoms or exacerbations, which can erode share for dual-therapy-only products.

5. What is the most common patent/lifecycle focus for this category?
   Device integration, formulation/particle engineering, and product presentation claims that delay substitution for specific inhaler formats.

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References

[1] FDA. Drug Trials Snapshots: Advair Diskus (fluticasone propionate and salmeterol inhalation powder). U.S. Food and Drug Administration.
[2] EMA. EPAR: Advair Diskus / Seretide (fluticasone propionate and salmeterol). European Medicines Agency.
[3] Global Initiative for Asthma (GINA). GINA Report: Global Strategy for Asthma Management and Prevention.
[4] Global Initiative for Chronic Obstructive Lung Disease (GOLD). GOLD Report: Global Strategy for Prevention, Diagnosis and Treatment of COPD.
[5] ClinicalTrials.gov. Search results for fluticasone propionate salmeterol xinafoate (query platform).