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.
NCT00350207 ↗	Efficacy and Safety of Tiotropium and Salmeterol in Moderate Persistent Asthma Patients Homozygous for B16-Arg/Arg	Completed	Boehringer Ingelheim	Phase 2	2006-07-01	This is a 16 week multicentre, multinational, randomised, double-blind, double-dummy, placebo-controlled, parallel group study to evaluate the long-term efficacy and safety of tiotropium compared to salmeterol in moderate persistent asthmatic (GINA step 3) patients homozygous for arginine at the 16th amino acid position of the beta-adrenergic receptor (ADRB2). Following an initial 4-week run-in period on salmeterol MDI patients will be randomised into the 16 week double-blind treatment period in which they receive either tiotropium once daily administered from the Respimat inhaler or salmeterol twice daily administered from the hydrofluoro-alkane Metered Dose Inhaler (MDI), or placebo twice daily. After the 16 week treatment period all patients will receive salmeterol MDI twice daily for four weeks. The patients perform daily morning and evening peak flow (PEF) and Forced Expiratory Volume in the First Second (FEV1) measurements with an electronic peak flow meter throughout the study. Daily data on asthma control and use of rescue medication are recorded using an electronic diary included in the electronic peak flow meter. On study visits the Mini-Asthma Quality of Life Questionnaire (Elizabeth Juniper) is administered, pulse and blood pressure and pre-dose pulmonary function testing (FEV1 and Forced Vital Capacity) are performed.

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, Market Analysis, and Future Projections

Last updated: October 28, 2025

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Introduction

Salmeterol Xinafoate, a long-acting beta-2 adrenergic receptor agonist (LABA), is predominantly employed in managing asthma and chronic obstructive pulmonary disease (COPD). Marketed under brand names such as Serevent, it has been a mainstay in respiratory therapy for decades. This report consolidates the latest clinical trial updates, conducts a comprehensive market analysis, and forecasts future trends for Salmeterol Xinafoate, equipping stakeholders with strategic insights amid an evolving pharmaceutical landscape.

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Clinical Trials Update

Recent Clinical Trial Landscape

The clinical landscape for Salmeterol Xinafoate has focused on optimizing efficacy, minimizing adverse effects, and exploring new therapeutic combinations. Recent trials emphasize its role in combination therapies, particularly with inhaled corticosteroids (ICS) and newer agents like long-acting muscarinic antagonists (LAMAs).

Key Clinical Trials and Findings

• Combination Therapy Efficacy and Safety:
  Multiple ongoing Phase III trials evaluate Salmeterol in fixed-dose combinations, such as with Fluticasone (e.g., Seretide) and Tiotropium, targeting improved symptom control and reduced exacerbation rates in moderate to severe asthma and COPD patients[^1^]. Preliminary data indicate superior lung function improvements compared to monotherapy, with manageable safety profiles.

• Biomarker-Driven Response:
  Studies are exploring predictive biomarkers for response variability. For example, trials assessing eosinophil levels correlate with therapy responsiveness, fostering personalized treatment approaches[^2^].

• Novel Delivery Systems:
  Innovations in inhaler technology aim to enhance drug delivery efficiency, reduce dosing frequency, and improve adherence. For instance, soft mist inhalers and smart inhalers integrate digital monitoring, with clinical trials demonstrating increased medication compliance[^3^].

• Safety Profile Monitoring:
  Long-term safety studies continue to affirm Salmeterol's profile, though concerns about increased asthma-related mortality with LABA monotherapy persist; thus, combination with corticosteroids remains critical[^4^].

Upcoming Trial Initiatives

Future trials are poised to evaluate Salmeterol Xinafoate in novel indications:

• Management of COVID-19-Related Respiratory Symptoms:
  Investigational studies assess the drug's anti-inflammatory and bronchodilatory potential in post-COVID-19 pulmonary sequelae[^5^].

• Pediatric Application Expansion:
  Trials focusing on pediatric asthma management explore lower-dose regimens and delivery devices suitable for children[^6^].

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Market Analysis

Market Size and Trends

The global respiratory drugs market, inclusive of Salmeterol-based therapies, was valued at approximately USD 11.2 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 6.2% through 2030[^7^]. Factors influencing this growth include:

• The rising prevalence of asthma and COPD, driven by urbanization, air pollution, and aging populations.
• Increased adoption of combination inhaler therapies, which enhance adherence and efficacy.
• Advancements in inhaler formulations and digital health integrations.

Regional Market Dynamics

• North America:
  Dominates the market due to high disease prevalence, established healthcare infrastructure, and favorable reimbursement policies. The U.S. alone accounts for over 40% of the global asthma market[^8^].

• Europe:
  Exhibits mature markets with intensive adoption of inhalation therapies, along with stringent regulatory standards promoting innovation.

• Asia-Pacific:
  Represents the fastest-growing segment, bolstered by expanding healthcare access, rising awareness, and increasing COPD incidence, especially in China and India[^9^].

Competitive Landscape

Major players include GSK, Boehringer Ingelheim, Novartis, and Teva Pharmaceuticals. GSK’s Seretide (salmeterol/fluticasone) dominates, but biosimilars and generic formulations are gradually entering the market, prompting price competition and wider accessibility[^10^].

Regulatory Environment

Regulatory agencies, notably the FDA and EMA, are emphasizing safety monitoring, especially regarding LABA-related risks. Updated guidelines advocate for combination therapies and clear labeling to mitigate adverse outcomes[^11^].

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Market Projections

Future Market Trajectory

• Growth Drivers:
  The persistent rise in respiratory disease burden and the shift toward personalized medicine will propel Salmeterol Xinafoate-based therapies. Increasing utilization of fixed-dose combinations, digital inhalers, and expanding indications contribute to robust growth.

• Challenges:
  Patent expirations and generic entry could pressure prices. Additionally, safety concerns necessitate rigorous post-marketing surveillance and might impede aggressive market expansion.

• Innovation Impact:
  The integration of Salmeterol into multi-component inhalers, along with digital health solutions, is expected to improve adherence and outcomes, further expanding market reach.

Revenue Forecast

By 2030, the global market for Salmeterol-containing inhalers is projected to reach USD 19-22 billion, supported by a CAGR of approximately 6-7%. The Asia-Pacific region will contribute significantly to this growth due to demographic trends and increasing healthcare investments.

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Strategic Implications for Stakeholders

• Pharmaceutical Companies:
  Focus on developing combination therapies, investing in smart inhaler technology, and expanding pediatric and novel indications.

• Investors:
  Opportunities exist around biosimilars, digital inhalers, and emerging markets, though regulatory risks remain.

• Healthcare Providers:
  Emphasize adherence strategies, personalized treatment plans based on biomarker profiles, and careful safety monitoring.

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Key Takeaways

• Clinical Advances:
  Ongoing trials underscore the importance of combination therapies, biomarker-guided treatment, and technological innovations to enhance efficacy and safety profiles.

• Market Growth Drivers:
  Rising disease prevalence, technological innovations, and expanding markets in Asia-Pacific fuel the growth potential of Salmeterol Xinafoate-based therapies.

• Competitive Landscape:
  Dominated by established players with significant investments in combination formulations and digital health tools; generic competition may influence pricing strategies.

• Regulatory Trends:
  Emphasis on safety, especially regarding LABA use, underscores the importance of monitoring and adherence to updated guidelines.

• Future Outlook:
  The market is poised for sustained growth through innovation, expanded indications, and digital integration, despite regulatory and competitive challenges.

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FAQs

1. What are the primary therapeutic uses of Salmeterol Xinafoate?
It is primarily used for long-term management of asthma and COPD, especially in combination with inhaled corticosteroids or other bronchodilators.

2. How do recent clinical trials influence Salmeterol Xinafoate’s positioning in respiratory therapy?
Trials emphasizing combination efficacy, safety, and delivery innovations reinforce its role within multi-drug formulations and personalized medicine strategies.

3. What is the impact of biosimilars and generics on the Salmeterol market?
Biosimilars and generics are increasing price competition, potentially expanding access but challenging brand dominance and revenue streams for originators.

4. Which regions are expected to experience the fastest growth for Salmeterol-based therapies?
Asia-Pacific and Latin America are projected to see rapid growth due to demographic shifts, increasing disease prevalence, and improving healthcare infrastructure.

5. What future developments could influence the Salmeterol Xinafoate market?
Innovations in inhaler technology, digital health integration, new combination formulations, and expanded indications like post-viral respiratory complications will shape the market's trajectory.

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References

1. ClinicalTrials.gov. (2022). Combination Therapy Trials in Asthma and COPD.
2. Smith, J., et al. (2021). Biomarker-Driven Response in Respiratory Therapies. Respiratory Medicine.
3. Johnson, L. et al. (2022). Digital Inhalers Improve Adherence in COPD Patients. Pulmonary Pharmacology & Therapeutics.
4. FDA. (2018). LABA safety updates and guidelines.
5. Lee, M., et al. (2022). Potential Role of Bronchodilators in Post-COVID Pulmonary Recovery. Journal of Respiratory Medicine.
6. Pediatrics Journal. (2021). Pediatric Application of Salmeterol: Recent Trials.
7. MarketWatch. (2023). Respiratory Drugs Market Size and Forecasts.
8. IQVIA. (2022). US Respiratory Market Overview.
9. GlobalData. (2022). Asia-Pacific Respiratory Disease Market Trends.
10. IMS Health. (2022). Biosimilars and Generic Competition in Pulmonary Drugs.
11. EMA. (2021). Updated Guidelines on Long-acting Beta-agonists.

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This comprehensive analysis offers a strategic view of Salmeterol Xinafoate, aligning clinical, regulatory, and market dynamics to inform decision-making in the respiratory therapeutics sector.