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
California	9
North Carolina	9
Missouri	8
Florida	8
Colorado	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
Unknown status	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

Last updated: April 28, 2026

Serevent (salmeterol): clinical trials update, market analysis, and projection

What is Serevent and where does it sit in the clinical-development landscape?

Serevent is the brand name for salmeterol, a long-acting beta-2 adrenergic agonist (LABA) used for maintenance treatment of asthma (in combination with inhaled corticosteroids) and symptomatic treatment of COPD. Commercially, Serevent is typically used as a dry powder inhaler (DPI) formulation in multiple regions, with prescriber guidance emphasizing LABA use only as add-on therapy for asthma.

Clinical-trials activity profile. For a marketed, off-patent respiratory molecule like salmeterol, the dominant “trial” footprint is usually:

• Post-marketing pharmacology/safety studies
• Formulation/device performance studies (bioavailability, inhalation performance, device equivalence)
• Comparative effectiveness studies in real-world settings rather than late-stage pivotal efficacy trials

This profile means the most decision-relevant “trial updates” for Serevent are generally regulatory labeling changes, device/formulation evolution, and new guideline positioning rather than new phase 3 drug-registration programs.

What clinical trials matter right now for Serevent?

Serevent’s latest meaningful clinical signal in routine use is guideline and labeling evolution tied to LABA safety management (notably the requirement that asthma patients receive LABA only with an inhaled corticosteroid). This is driven by the broader LABA safety program history and ongoing pharmacovigilance patterns across the class.

From a patent-analyst lens, the practical “trial update” that affects market durability is whether regulators continue to require:

• LABA use only in combination with ICS for asthma
• Clear warnings against LABA monotherapy for asthma
• Ongoing safety monitoring for class-relevant risks

Because salmeterol is established, the commercially material trials in most jurisdictions are not new drug candidates but device and formulation confirmations that preserve market supply and continuity.

What is the current market structure for Serevent and salmeterol LABAs?

Market context. The salmeterol market sits inside the broader inhaled respiratory segment:

• LABA plus ICS combinations dominate asthma maintenance spend
• COPD treatment includes LABAs and LABA/LAMA combinations
• Generic erosion affects standalone LABAs where patents have expired

Competitive field (category level).

• LABA molecules: salmeterol and formoterol
• Combinations: LABA/ICS (e.g., salmeterol fluticasone combinations in multiple geographies) and LABA/LAMA for COPD

Where Serevent fits.

• Serevent as standalone salmeterol is most exposed to generic competition and to guideline preference for combination inhalers in asthma.
• Its COPD position can persist where clinicians use LABA monotherapy or where combination therapy access and patient factors sustain standalone LABA use.

How does generic pressure typically affect standalone salmeterol brands?

Standalone LABA brands usually face:

• Price compression after generic entry
• Switching to combination products in asthma
• Formulary consolidation toward fewer products based on payer preference

For investors and R&D planners, the key takeaway is that Serevent’s revenue durability depends less on “new clinical efficacy” and more on:

• whether supply chains and devices remain payer-favored
• the extent to which clinicians keep patients on standalone LABA vs switching to LABA/ICS or LABA/LAMA strategies
• local reimbursement and tender dynamics

What is a practical market projection for Serevent over the next 5 to 10 years?

Given salmeterol’s maturity, the baseline projection for a brand like Serevent is typically:

• Low to mid single-digit volume decline in most mature markets
• Flat to declining value due to generic mix and contracting pricing
• Stability only if the brand retains formulary share via device differentiation or bundling with combination prescribing behavior

Without region-specific sales baselines and without a dataset of current Serevent unit share by geography, the only defensible forward view is directional at the category and brand-structure level: Serevent should track mature respiratory inhaler trends with persistent downward pressure from generic penetration and combination preference.

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Market projection model (directional, decision-focused)

Key drivers

1. Asthma prescribing behavior

   • LABA use is constrained to ICS-combination regimens
   • Standalone LABA share declines where combination products are payer-preferred

2. COPD regimen evolution

   • Movement toward dual (LABA/LAMA) and triple therapy (ICS/LABA/LAMA) where clinically appropriate
   • Standalone LABA remains but loses share at the margin

3. Generic erosion

   • Standalone salmeterol brands experience sustained price competition
   • Device-based continuity can slow erosion but rarely halts it

4. Regulatory risk posture

   • Class-wide LABA warnings constrain promotional flexibility
   • Ongoing pharmacovigilance may drive incremental labeling changes, not new indications that expand market rapidly

Projected outcomes

• 5-year: continued volume friction and value compression; modest stabilization is possible only in pockets where formulary access favors the brand/device.
• 10-year: likely sustained decline in standalone LABA share unless a payer/device strategy preserves brand use or local regulatory pathways maintain brand differentiation.

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Clinical trials timeline impact (how to read the “trial update” for an established LABA)

For Serevent, the decision-relevant “trial” updates typically arrive as:

• Device equivalence studies needed to keep inhaler performance consistent
• Bioavailability and inhalation delivery performance work tied to product lifecycle management
• Safety surveillance reporting integrated into pharmacovigilance programs
• Guideline updates that change the role of LABAs in asthma maintenance

This means the practical clinical-development posture is usually “maintenance,” not “expansion.”

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What this means for R&D and investment

R&D implications

• New filings for salmeterol itself are usually not competitive unless tied to:
  • novel delivery systems
  • new fixed-dose combinations
  • patient adherence innovations with demonstrable outcomes
• The higher-value development strategy in this space remains new combinations and differentiated inhaler platforms, not incremental efficacy on salmeterol monotherapy.

Investment implications

• Serevent’s upside is limited by:
  • generic substitution risk
  • guideline concentration toward combination inhalers
  • mature market uptake
• If underwriting Serevent exposure, focus on:
  • formulary share persistence for the specific inhaler/device
  • local pricing dynamics
  • mix of asthma vs COPD usage in each geography

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Key Takeaways

• Serevent (salmeterol) is a mature LABA with clinical value anchored in long-established maintenance therapy patterns, not new late-stage drug-efficacy trials.
• Current “clinical trial updates” for an established LABA largely translate into device/formulation confirmation work and ongoing safety surveillance that reinforces LABA use with ICS for asthma.
• Market outlook is structurally constrained by generic penetration and payer preference shifts toward LABA/ICS for asthma and LABA/LAMA or triple therapy for COPD.
• A realistic projection for Serevent is continued decline in standalone LABA share/value in mature markets, with limited stabilization possible only where device and formulary dynamics sustain brand use.

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FAQs

1) Does Serevent have active phase 3 development that could change its commercial outlook?

Serevent’s development profile is typically maintenance-oriented (device/formulation and surveillance) rather than new phase 3 pivotal trials that would reset market assumptions.

2) What is the main clinical safety constraint affecting Serevent prescribing?

LABA therapy for asthma requires pairing with an inhaled corticosteroid and avoids LABA monotherapy in asthma, based on class safety posture and labeling.

3) Why does Serevent face more pressure than many combination inhalers?

Standalone LABAs are more exposed to generic substitution and to prescribing shifts that favor combination inhalers for asthma maintenance.

4) Where can Serevent still hold share?

Where formulary access and device-specific continuity support ongoing clinician/payer preference, especially in narrower COPD-use patterns and in geographies with less aggressive generic substitution.

5) What should an investor underwrite for Serevent exposure?

Underwrite pricing trajectory, formulary share retention at the inhaler/device level, asthma versus COPD mix, and the pace of generic substitution in each target market.

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References

[1] U.S. Food and Drug Administration. Serevent Diskus prescribing information. FDA label.
[2] U.K. Medicines and Healthcare products Regulatory Agency (MHRA). Salmeterol product information and safety communications.
[3] Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention. Latest published guideline (LABA use with ICS guidance).
[4] Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global Strategy for the Diagnosis, Management, and Prevention of COPD. Latest published guideline (LABA/LAMA positioning).