CLINICAL TRIALS PROFILE FOR SALMETEROL XINAFOATE

505(b)(2) Clinical Trials for 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.
New Formulation	NCT02254226 ↗	Pharmacokinetics of Salmeterol (Serevent®) After Inhalation With Metered Dose Inhaler (MDI) and Diskus® in Healthy Male Volunteers	Completed	Boehringer Ingelheim	Phase 1	2004-11-01	1. To compare the systemic drug exposure of 100 μg Serevent ® Diskus ® with that of 50 μg Serevent ® MDI with sufficient precision so that in combination with a second trial it can be demonstrated that the systemic drug exposure of a new formulation of salmeterol xinafoate is not superior to that of Serevent ® MDI 2. To test a system of ordered null hypotheses regarding the exposure of two dose levels of Serevent ® Diskus ® and Serevent ® MDI 3. To get data about the systemic drug exposure of 25 μg Serevent ® MDI and of 50 μg Serevent ® Diskus ®

All Clinical Trials for 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.
NCT00127166 ↗	Two Investigational Drugs in the Prevention of Airway Constriction Brought on by Exercise in Participants With Asthma (0476-911)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2005-12-01	The purpose of this study is to determine the effect of four weeks of treatment with two investigational drugs (oral versus inhaled administration) plus an inhaled medication in the treatment of airway constriction brought on by exercise in participants with asthma.
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.
NCT00269126 ↗	Clinical Evaluation Of GW815SF For Chronic Obstructive Pulmonary Disease (Chronic Bronchitis, Emphysema)	Completed	GlaxoSmithKline	Phase 3	2005-02-01	This study compares the effect of two medicines on COPD (Chronic Obstructive Pulmonary Disease). This study will last up to 18 weeks, and subjects will visit the clinic 5 times. Subjects will be given breathing tests, and will record their breathing symptoms daily on diary cards.

Clinical Trial Conditions for Salmeterol Xinafoate

Condition Name

Condition Name for Salmeterol Xinafoate
Intervention	Trials
Asthma	22
Bioequivalence	12
Pulmonary Disease, Chronic Obstructive	10
Chronic Obstructive Pulmonary Disease	3

Condition MeSH

Condition MeSH for Salmeterol Xinafoate
Intervention	Trials
Asthma	24
Pulmonary Disease, Chronic Obstructive	15
Lung Diseases	15
Lung Diseases, Obstructive	13

Clinical Trial Locations for Salmeterol Xinafoate

Trials by Country

Trials by Country for Salmeterol Xinafoate
Location	Trials
United States	257
Greece	15
Germany	12
South Africa	10
Australia	9

Trials by US State

Trials by US State for Salmeterol Xinafoate
Location	Trials
California	13
Texas	13
Colorado	12
Missouri	12
North Carolina	11

Clinical Trial Progress for Salmeterol Xinafoate

Clinical Trial Phase

Clinical Trial Phase for Salmeterol Xinafoate
Clinical Trial Phase	Trials
Phase 4	8
Phase 3	12
Phase 2	10

Clinical Trial Status

Clinical Trial Status for Salmeterol Xinafoate
Clinical Trial Phase	Trials
Completed	47
Not yet recruiting	4
Active, not recruiting	2

Clinical Trial Sponsors for Salmeterol Xinafoate

Sponsor Name

Sponsor Name for Salmeterol Xinafoate
Sponsor	Trials
GlaxoSmithKline	14
Becro Ltd.	12
Respirent Pharmaceuticals Co Ltd.	12

Sponsor Type

Sponsor Type for Salmeterol Xinafoate
Sponsor	Trials
Industry	69
Other	11
NIH	3

Salmeterol Xinafoate: Clinical Trials Update and Market Outlook (Forecast Through Patent-Exposure Horizon)

Last updated: April 24, 2026

What is salmeterol xinafoate and where is it used commercially?

Salmeterol xinafoate is a long-acting beta2-adrenergic agonist (LABA) used as maintenance therapy for asthma (with an inhaled corticosteroid) and COPD. In the U.S. and major markets, it is marketed primarily as fixed-dose combinations with inhaled corticosteroids, including products historically tied to brands such as Advair (fluticasone propionate/salmeterol) and Seretide (fluticasone propionate/salmeterol) in many geographies.

From a patent-analysis standpoint, salmeterol xinafoate’s commercial exposure is driven more by:

• Device and formulation IP (inhaler type, particle engineering, inhalation performance), and
• Combo-product IP (the ICS-LABA combination and associated dosing regimens), than by any single-molecule exclusivity remaining for the API alone.

What is the clinical trials update for salmeterol xinafoate?

A complete, time-bounded “clinical trials update” requires a verified snapshot of active and completed studies, with identifiers (e.g., NCT numbers) and dates. No trial dataset was provided, and no reliable, citable registry extract is available in the prompt. Under the operating constraints, a complete and accurate clinical-trials section cannot be produced.

How big is the salmeterol xinafoate market today?

A complete market analysis also requires a defined scope (global vs. major markets, product form, whether to include combination products, and whether to count API sales, inhaler unit sales, or branded revenues). No scope or dataset is provided, and the prompt does not include any figures, sources, or definitions. Under the operating constraints, a complete and accurate market model cannot be produced.

What is the market projection and key drivers?

A forward projection for a legacy LABA depends on:

• Respiratory category growth (asthma and COPD),
• Share shift within inhaler classes (LABA/ICS vs LABA/LAMA),
• Competitive dynamics driven by generic and authorized generic entries for combination products,
• Uptake of newer delivery devices (respimat, dry powder inhalers with engineered dose uniformity),
• Guideline adherence and payer formulary behavior.

No numeric assumptions, forecast horizon, or market sizing baseline is provided, and no citable forecast model inputs are included. Under the operating constraints, projection cannot be generated without risking inaccuracy.

Patent and regulatory exposure: how to frame risk for salmeterol xinafoate

While the prompt requests market and clinical trial updates, patent exposure remains the only element that can be stated without inventing registry or sizing numbers. For salmeterol xinafoate, the practical IP risk is typically combination-product and formulation/device driven rather than late-stage molecule exclusivity.

Core IP categories that typically govern salmeterol combo products

• ICS-LABA combination composition of matter (often long expired or close to expiry depending on jurisdiction)
• Formulation patents (particle size distribution, crystallinity, spray-dried blends, excipient systems)
• Inhaler device patents (metering, dose counting, aerosol generation mechanics)
• Method-of-use patents (specific dosing regimens, age cohorts, COPD phenotype claims)
• Regulatory exclusivity (data exclusivity and market exclusivity tied to the specific product approval history)

Business impact

For investors and R&D planners, salmeterol xinafoate is typically a strategy-dependent platform: incremental differentiation usually comes from device and formulation, not from novel pharmacology.

What actionable conclusions can be drawn from the available information?

None on clinical trials or market size can be stated without verifiable sources and identifiers. The only actionable, non-speculative guidance is the IP exposure framing above, which informs:

• where to look for defensible differentiation (device + formulation),
• what to diligence (product-level IP, not API-only),
• how to structure investment cases (focus on next-in-class inhaler differentiation or combo-specific life-cycle management).

---

Key Takeaways

• Salmeterol xinafoate is a LABA used primarily in ICS-LABA combinations for asthma and in LABA-based maintenance strategies for COPD.
• Commercial and IP exposure is typically driven by combo-product, formulation, and device patents rather than any remaining molecule-only exclusivity.
• A clinical trials update and a quantified market projection cannot be produced from the provided prompt without an external registry and market dataset.

FAQs

1. Is salmeterol xinafoate marketed as a standalone drug?
   It is most commonly commercialized as part of fixed-dose ICS-LABA combination inhalers.

2. What patent areas most influence competitiveness for salmeterol-based inhalers?
   Combination-product IP, formulation, and inhaler device patents typically drive life-cycle protection.

3. Does the therapeutic focus for salmeterol xinafoate include asthma and COPD?
   Yes, it is used for asthma maintenance (with an ICS) and COPD maintenance.

4. What makes clinical development for salmeterol-based products different from de novo drugs?
   Incremental clinical work often targets device delivery performance, dosing convenience, and comparative effectiveness rather than discovering a new mechanism.

5. What is the most important diligence task for investors assessing salmeterol exposure?
   Map protection to the specific marketed product(s) and their device/formulation claims, not the API alone.

---

References

No citable sources were provided in the prompt, and no external trial or market dataset was included; therefore, no references can be listed without fabricating citations.