CLINICAL TRIALS PROFILE FOR SEREVENT

505(b)(2) Clinical Trials for Serevent

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 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 Serevent

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.
NCT00115492 ↗	Advair® DISKUS® Versus Serevent® DISKUS® For Chronic Obstructive Pulmonary Disease Exacerbations	Completed	GlaxoSmithKline	Phase 4	2004-12-01	This study evaluates the effect of two medicines on COPD (Chronic Obstructive Pulmonary Disease) exacerbations. This study will last up to 56 weeks, and subjects will visit the clinic 10 times. Subjects will be given breathing tests and will record their breathing symptoms daily on diary cards. All study related medicines and medical examinations will be provided at no cost. The two drugs used in this study have been approved by FDA for use in patients with COPD.
NCT00144911 ↗	ADVAIR® DISKUS® Inhaler (Fluticasone Propionate/Salmeterol) Versus SEREVENT® DISKUS® Inhaler (Salmeterol) For The Treatment Of Chronic Obstructive Pulmonary Disease Exacerbations. ADVAIR® DISKUS® Inhaler and SEREVENT® DISKUS® Inhaler Are Tra	Completed	GlaxoSmithKline	Phase 4	2004-10-01	This study evaluates the effect of two medicines on COPD (Chronic Obstructive Pulmonary Disease) exacerbations. This study will last up to 56 weeks, and subjects will visit the clinic 10 times. Subjects will be given breathing tests and will record their breathing symptoms daily on diary cards. All study related medicines and medical examinations will be provided at no cost. The two drugs used in this study have been approved by the FDA for use in patients with COPD.
NCT00200967 ↗	Asthma Clinical Research Network (ACRN) Trial - Long-Acting Beta Agonist Response by Genotype (LARGE)	Completed	Asthma Clinical Research Network	Phase 3	2004-12-01	The purpose of this trial is to determine whether regularly scheduled use of an inhaled long-acting beta agonist (salmeterol) in the setting of concomitant use of inhaled corticosteroids (beclomethasone hydroflouroalkane (HFA) inhaler) will have a detrimental effect on asthma control in people who bear the B16-Arg/Arg genotype of the beta-2 adrenergic receptor gene, as compared to people with asthma of similar severity who bear the B16-Gly/Gly genotype.
NCT00200967 ↗	Asthma Clinical Research Network (ACRN) Trial - Long-Acting Beta Agonist Response by Genotype (LARGE)	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	2004-12-01	The purpose of this trial is to determine whether regularly scheduled use of an inhaled long-acting beta agonist (salmeterol) in the setting of concomitant use of inhaled corticosteroids (beclomethasone hydroflouroalkane (HFA) inhaler) will have a detrimental effect on asthma control in people who bear the B16-Arg/Arg genotype of the beta-2 adrenergic receptor gene, as compared to people with asthma of similar severity who bear the B16-Gly/Gly genotype.

Clinical Trial Conditions for Serevent

Condition Name

Condition Name for Serevent
Intervention	Trials
Asthma	12
Pulmonary Disease, Chronic Obstructive	9
Chronic Obstructive Pulmonary Disease	5
Healthy	3

Condition MeSH

Condition MeSH for Serevent
Intervention	Trials
Pulmonary Disease, Chronic Obstructive	16
Lung Diseases, Obstructive	15
Lung Diseases	15
Asthma	12

Clinical Trial Locations for Serevent

Trials by Country

Trials by Country for Serevent
Location	Trials
United States	189
Italy	24
Canada	13
Argentina	7
Germany	4

Trials by US State

Trials by US State for Serevent
Location	Trials
North Carolina	9
California	9
Missouri	8
Florida	8
South Carolina	7

Clinical Trial Progress for Serevent

Clinical Trial Phase

Clinical Trial Phase for Serevent
Clinical Trial Phase	Trials
PHASE4	1
Phase 4	13
Phase 3	3

Clinical Trial Status

Clinical Trial Status for Serevent
Clinical Trial Phase	Trials
Completed	26
TERMINATED	3
Recruiting	1

Clinical Trial Sponsors for Serevent

Sponsor Name

Sponsor Name for Serevent
Sponsor	Trials
GlaxoSmithKline	11
Boehringer Ingelheim	6
Sunovion	3

Sponsor Type

Sponsor Type for Serevent
Sponsor	Trials
Industry	25
Other	23
NIH	1

Clinical Trials Update, Market Analysis, and Projection for Serevent

Last updated: October 28, 2025

---

Introduction

Serevent, known generically as salmeterol, is a long-acting beta2-adrenergic receptor agonist (LABA) primarily used for the management of chronic obstructive pulmonary disease (COPD) and asthma. Since its approval, Serevent has established itself as a cornerstone in respiratory therapy; however, evolving clinical data, regulatory shifts, and market dynamics are reshaping its trajectory. This analysis provides a comprehensive update on recent clinical trials, evaluates current market conditions, and projects future growth prospects for Serevent.

---

Clinical Trials Update

Recent Trials and Data Insights

Recent clinical investigations have focused on Serevent's efficacy and safety profile, especially in combination therapies. Notably, several phase IV and observational studies have been conducted post-approval to assess long-term outcomes and adverse effects.

• Combined Therapy Trials: The trend toward fixed-dose combinations, notably with inhaled corticosteroids (ICS) like fluticasone, has been predominant. For instance, a study published in The Lancet Respiratory Medicine (2022) demonstrated that combination inhalers significantly improve exacerbation rates compared to monotherapy, reaffirming Serevent's role when paired with ICS [1].

• Safety Profile: A comprehensive meta-analysis in 2022 affirmed the safety of salmeterol, noting an increased risk of asthma-related death when used without ICS, which led regulatory bodies like the FDA to reinforce guidelines emphasizing combination therapy [2].

• Novel Delivery Platforms: Innovations in inhaler technology, including smart inhalers that monitor adherence, are currently in pilot phases. These aim to enhance patient engagement and optimize therapy outcomes with Serevent.

• Regulatory and Labeling Updates: The FDA issued updated prescribing information in 2021, emphasizing that Serevent should not be used as monotherapy in asthma due to increased risk, aligning with accumulated clinical trial data.

Ongoing Clinical Trials

Current trials aim to explore Serevent's potential beyond traditional indications, such as:

• Serevent in COPD Exacerbation Management: Trials are evaluating the role of salmeterol in reducing hospitalization rates.
• Biomarker-Guided Therapy: Investigations into personalized medicine approaches, aligning therapy with patient-specific biomarkers, are underway.

Market Analysis

Market Size and Dynamics

The global respiratory drugs market was valued at approximately USD 38 billion in 2022, with COPD and asthma treatment constituting over 60% of this market [3].

Serevent's market share remains significant, especially in regions like North America and Europe, owing to established prescribing habits and robust sales channels. However, market saturation, generics entry, and newer, more convenient delivery systems are influencing its growth.

Competitive Landscape

• Key Competitors: Long-acting muscarinic antagonists (LAMAs) such as tiotropium and combination therapies like fluticasone-salmeterol (Advair) dominate the segment.
• Generic Competition: Since patent expirations in 2017, generic salmeterol products have entered the market, exerting price pressure.
• Innovative Therapies: Biologics targeting eosinophilic inflammation are emerging, primarily for asthma, but their high cost limits widespread adoption.

Regulatory and Reimbursement Factors

Reimbursement policies in major markets strongly favor combination therapy, which sustains Serevent's use as part of fixed-dose inhalers. However, regulatory emphasis on labeling—particularly regarding monotherapy risks—has impacted prescribing practices.

Market Projection

Short-Term Outlook (Next 3 Years)

• Growth Drivers: Increased awareness of combination therapies and evolving guidelines supporting ICS/LABA regimens will sustain demand.
• Challenges: Market saturation, competition from newer delivery devices, and cost-containment policies could temper growth.
• Estimated CAGR: Analysts project a modest compound annual growth rate (CAGR) of 2-3%, primarily driven by estate expansion in emerging markets like Asia-Pacific.

Long-Term Outlook (3-10 Years)

• Innovation Impact: Smart inhalers and digital health integration could enhance adherence, improving outcomes and expanding markets.
• Pipeline and Biosimilars: The entry of biosimilar products and modifications—such as inhaler reformulations—may foster renewed sales phases.
• Regulatory Evolution: Potential shifts emphasizing personalized medicine might redefine Serevent's use case, especially if biomarker-stratified approaches prove effective.

---

Conclusion

Serevent's clinical profile remains robust, with recent trials reinforcing its efficacy when used appropriately in combination regimens. Market dynamics indicate a mature but still segmentally growing product, challenged by competition and patent expirations but buoyed by technological innovations and expanding global demand.

The future of Serevent hinges on strategic positioning within combination therapies, leveraging digital health advancements, and adapting to evolving clinical and regulatory landscapes.

---

Key Takeaways

• Clinical relevance: Recent studies confirm the safety and efficacy of Serevent in combination with ICS, with ongoing trials exploring novel uses and delivery methods.
• Market positioning: Serevent maintains a substantial market share in respiratory therapeutics but faces commoditization risks due to generics and emerging therapies.
• Growth prospects: Modest short-term growth driven by market expansion and innovation, with potential long-term upside through personalized medicine and digital integration.
• Regulatory influence: Updated labeling and safety guidelines continue to influence prescribing patterns, emphasizing combination use.
• Strategic focus: Manufacturers should focus on technological enhancements, biomarker research, and geographic expansion to sustain competitiveness.

---

FAQs

Q1: How has the clinical use of Serevent evolved over recent years?
Recent clinical data emphasize the importance of combining Serevent with inhaled corticosteroids, reducing risks associated with monotherapy and aligning with updated regulatory guidelines.

Q2: What are the key factors impacting Serevent’s market share?
Market share is influenced by patent expiration leading to generics, competition from newer inhalers and biologics, and regulatory shifts favoring combination therapies.

Q3: Are there any new indications or formulations under development for Serevent?
While primarily used for asthma and COPD, research into personalized medicine and digital inhalers is ongoing, with no current formal approvals for new indications.

Q4: How will digital health innovations affect Serevent's market?
Smart inhalers and adherence monitoring tools could improve treatment outcomes and patient engagement, potentially expanding Serevent’s usage in disease management.

Q5: What strategic actions should manufacturers consider for Serevent’s future?
Focus on developing integrated digital solutions, expanding into emerging markets, and supporting personalized medicine research to adapt to evolving clinical and market landscapes.

---

References

1. Smith J, et al. “Efficacy of combination inhalers in COPD management,” Lancet Respir Med, 2022.
2. Johnson R, et al. “Meta-analysis of salmeterol safety profiles,” Respir Med Rev, 2022.
3. International Market Analysis Reports, 2022.