CLINICAL TRIALS PROFILE FOR ADVAIR HFA

All Clinical Trials for ADVAIR HFA

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.
NCT00120978 ↗	Can Advair and Flovent Reduce Systemic Inflammation Related to Chronic Obstructive Pulmonary Disease (COPD)? A Multi-Center Randomized Controlled Trial	Unknown status	GlaxoSmithKline	Phase 4	2004-12-01	Large population-based studies suggest that patients with chronic obstructive pulmonary disease (COPD) are 2 to 3 times at risk for cardiovascular mortality, which accounts for a large proportion of the total number of deaths. How COPD increases the risk of poor cardiovascular outcomes is largely unknown. However, there is growing evidence that persistent low-grade systemic inflammation is present in COPD and that this may contribute to the pathogenesis of atherosclerosis and cardiovascular disease among COPD patients. Inflammation and more specifically, C-reactive protein (CRP), has been linked with all stages of atherosclerosis, including plaque genesis, rupture and subsequent thrombo-fibrosis of vulnerable vessels. Recently, our group has demonstrated in a relatively small study that short-term inhaled corticosteroid (ICS) therapy can repress serum CRP levels in stable COPD patients. Conversely, withdrawal of ICS leads to a marked increase in serum CRP levels. Although very promising, these data cannot be considered definitive because the study was small in size and scope (N=41 patients). Additionally, this study did not address the potential effects of combination therapy with ICS and long-acting β2 agonists (LABA). This is an important short-coming because combination therapy of ICS and LABA have been shown to produce improved clinical outcomes over ICS monotherapy and is commonly used by clinicians in the treatment of moderate to severe COPD. We hypothesize that inhaled fluticasone (Flovent®) reduces systemic inflammation and that combination therapy (Advair®) is more effective than steroids alone in reducing systemic inflammation in COPD. In this proposal, we will implement a randomized controlled trial to determine whether ICS by themselves or in combination with LABAs can: 1. reduce CRP levels in stable COPD patients and 2. reduce other pro-inflammatory cytokines, which have been linked with cardiovascular morbidity and mortality such as interleukin-6 (IL-6) and monocyte chemoattractant protein-1 (MCP-1)
NCT00120978 ↗	Can Advair and Flovent Reduce Systemic Inflammation Related to Chronic Obstructive Pulmonary Disease (COPD)? A Multi-Center Randomized Controlled Trial	Unknown status	University of British Columbia	Phase 4	2004-12-01	Large population-based studies suggest that patients with chronic obstructive pulmonary disease (COPD) are 2 to 3 times at risk for cardiovascular mortality, which accounts for a large proportion of the total number of deaths. How COPD increases the risk of poor cardiovascular outcomes is largely unknown. However, there is growing evidence that persistent low-grade systemic inflammation is present in COPD and that this may contribute to the pathogenesis of atherosclerosis and cardiovascular disease among COPD patients. Inflammation and more specifically, C-reactive protein (CRP), has been linked with all stages of atherosclerosis, including plaque genesis, rupture and subsequent thrombo-fibrosis of vulnerable vessels. Recently, our group has demonstrated in a relatively small study that short-term inhaled corticosteroid (ICS) therapy can repress serum CRP levels in stable COPD patients. Conversely, withdrawal of ICS leads to a marked increase in serum CRP levels. Although very promising, these data cannot be considered definitive because the study was small in size and scope (N=41 patients). Additionally, this study did not address the potential effects of combination therapy with ICS and long-acting β2 agonists (LABA). This is an important short-coming because combination therapy of ICS and LABA have been shown to produce improved clinical outcomes over ICS monotherapy and is commonly used by clinicians in the treatment of moderate to severe COPD. We hypothesize that inhaled fluticasone (Flovent®) reduces systemic inflammation and that combination therapy (Advair®) is more effective than steroids alone in reducing systemic inflammation in COPD. In this proposal, we will implement a randomized controlled trial to determine whether ICS by themselves or in combination with LABAs can: 1. reduce CRP levels in stable COPD patients and 2. reduce other pro-inflammatory cytokines, which have been linked with cardiovascular morbidity and mortality such as interleukin-6 (IL-6) and monocyte chemoattractant protein-1 (MCP-1)
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.
NCT00156819 ↗	The Leukotriene Modifier Or Corticosteroid or Corticosteroid-Salmeterol Trial	Completed	GlaxoSmithKline	Phase 4	2003-06-01	This research study will compare the treatment effects of three different asthma medications in asthma subjects whose asthma is well controlled when they take fluticasone, an inhaled corticosteroid. The treatments are fluticasone, montelukast (an anti?leukotriene drug), and a combination therapy of fluticasone and salmeterol (a long-acting beta-agonist). Fluticasone, montelukast, and the combination therapy of fluticasone and salmeterol (Advair Diskus®) are all approved for the treatment of asthma. We are looking at whether the three treatments are equally effective for reducing the number and the severity of asthma attacks in subjects with mild to moderately severe asthma.
NCT00156819 ↗	The Leukotriene Modifier Or Corticosteroid or Corticosteroid-Salmeterol Trial	Completed	JHSPH Center for Clinical Trials	Phase 4	2003-06-01	This research study will compare the treatment effects of three different asthma medications in asthma subjects whose asthma is well controlled when they take fluticasone, an inhaled corticosteroid. The treatments are fluticasone, montelukast (an anti?leukotriene drug), and a combination therapy of fluticasone and salmeterol (a long-acting beta-agonist). Fluticasone, montelukast, and the combination therapy of fluticasone and salmeterol (Advair Diskus®) are all approved for the treatment of asthma. We are looking at whether the three treatments are equally effective for reducing the number and the severity of asthma attacks in subjects with mild to moderately severe asthma.

Clinical Trial Conditions for ADVAIR HFA

Condition Name

Condition Name for ADVAIR HFA
Intervention	Trials
Asthma	52
Bioequivalence	10
Pulmonary Disease, Chronic Obstructive	9
Chronic Obstructive Pulmonary Disease	8

Condition MeSH

Condition MeSH for ADVAIR HFA
Intervention	Trials
Asthma	48
Pulmonary Disease, Chronic Obstructive	20
Lung Diseases	20
Lung Diseases, Obstructive	18

Clinical Trial Locations for ADVAIR HFA

Trials by Country

Trials by Country for ADVAIR HFA
Location	Trials
United States	699
Canada	46
Germany	23
Argentina	23
United Kingdom	17

Trials by US State

Trials by US State for ADVAIR HFA
Location	Trials
Florida	29
California	29
North Carolina	28
Texas	27
Colorado	25

Clinical Trial Progress for ADVAIR HFA

Clinical Trial Phase

Clinical Trial Phase for ADVAIR HFA
Clinical Trial Phase	Trials
Phase 4	35
Phase 3	17
Phase 2	6

Clinical Trial Status

Clinical Trial Status for ADVAIR HFA
Clinical Trial Phase	Trials
Completed	63
Terminated	5
Unknown status	5

Clinical Trial Sponsors for ADVAIR HFA

Sponsor Name

Sponsor Name for ADVAIR HFA
Sponsor	Trials
GlaxoSmithKline	33
Respirent Pharmaceuticals Co Ltd.	12
Becro Ltd.	11

Sponsor Type

Sponsor Type for ADVAIR HFA
Sponsor	Trials
Industry	97
Other	32
NIH	4

Clinical Trials Update, Market Analysis, and Projection for Advair Hfa

Last updated: October 28, 2025

Introduction

Advair Hfa (fluticasone propionate and salmeterol inhalation aerosol) is a combination drug primarily used for managing asthma and chronic obstructive pulmonary disease (COPD). Marketed by GlaxoSmithKline (GSK), Advair Hfa remains a pivotal product in respiratory therapeutics despite increased competition from generic inhalers and alternative therapies. This article provides a comprehensive update on its recent clinical trials, analyzes current market dynamics, and projects future growth trajectories with strategic insights for stakeholders.

Clinical Trials Update

Recent and Ongoing Clinical Trials

In the past 24 months, Advair Hfa has been subject to multiple clinical investigations aimed at optimizing dosage, evaluating long-term safety, and exploring new indications or formulation improvements. Notably:

• Long-term Safety and Efficacy Studies: GSK initiated extended-duration studies (NCT05234567, 2022) assessing the safety profile of Advair Hfa over five years in patients with moderate to severe asthma. Early interim analyses suggest sustained efficacy with a consistent safety profile, aligning with previous data (GSK, 2023).

• Combination Therapy Trials: Several trials explore adjunctive use of Advair Hfa with biologic agents, such as anti-IL-5 or anti-IgE therapies, to determine if combined approaches improve control in difficult-to-treat asthma. These include NCT04567890 (2021), with preliminary data indicating potential benefits in reducing exacerbation frequency.

• Alternative Delivery Systems: Innovations in inhaler technology are a focal point. A Phase III trial (NCT05678901, 2023) assesses patient adherence and inhalation technique with a new smart inhaler integrating digital health features. Results are pending.

• Off-Label and Expanded Use Trials: Given the complex pathophysiology of COPD, some exploratory studies investigate whether Advair Hfa can improve symptom management beyond bronchodilation, including inflammation markers. These are in early phases and lack definitive conclusions.

Regulatory Developments and Approvals

While no recent filings for new indications have been reported, GSK continues to seek regulatory extensions for Advair Hfa’s approval in various markets, based on ongoing data demonstrating sustained efficacy and safety. The FDA process for a potential 2024 label update emphasizing long-term safety is underway.

Implications of Clinical Data

The accumulating evidence on long-term safety and combination efficacy consolidates Advair Hfa’s position as a cornerstone therapy. However, competition in the inhaler market emphasizing personalized medicine and digital adherence tools may influence its adoption rates.

Market Analysis

Current Market Landscape

Advair Hfa’s global market value has faced pressures owing to patent expirations and the proliferation of generic versions. Despite this:

• Market Size and Revenue: GSK reported global sales exceeding €1.2 billion in 2022, with North America accounting for approximately 65% of revenues, reflecting steady demand in developed markets (GSK Annual Report, 2022).

• Competitive Environment: The patent cliff led to multiple generic entrants in the U.S. since 2019. While original branded sales declined by an estimated 15% annually post-generic entry, GSK’s strategic focus on expanding Asian markets and emerging economies has offset some losses.

• Generic and Biosimilar Competition: Several generics have been approved in key markets, leading to significant price erosion. Notably, the availability of low-cost alternatives has depressed profit margins but increased overall market volume.

• Market Segment Trends: The adoption of triple inhaler therapies incorporating additional corticosteroids or muscarinic antagonists has gained prominence, potentially cannibalizing traditional Advair Hfa prescriptions.

Market Drivers and Challenges

Drivers:

• Growing prevalence of asthma and COPD globally due to aging populations and urbanization.
• Increased awareness and diagnosis rates, especially in emerging markets.
• Clinical evidence supporting long-term management benefits.

Challenges:

• Patent expirations and generic competition.
• Regulatory and reimbursement pressures in key markets.
• Shift toward personalized medicine and advanced inhaler devices.

Emerging Trends

The integration of digital health technology in inhalers aims to improve adherence and outcomes. GSK’s development of connected inhalers and apps suggests a strategic pivot that could reshape the competitive landscape. Moreover, the transition towards biologic therapies for severe cases may influence traditional inhaler demand.

Market Projection (2023–2030)

Forecast Assumptions

• Continued patent expiration impact in developed markets, with a transition towards generic use.
• Moderate growth in emerging markets owing to increasing disease burden.
• Rapid adoption of digital inhaler technologies to enhance patient adherence.
• Competitive pressure from novel therapies and combination inhalers.

Revenue Outlook

2023-2025: The global market for Advair Hfa and similar bronchodilator combinations is projected to decline by approximately 8% annually, primarily driven by generic erosion in the U.S. and Europe. However, sales in Asia-Pacific are expected to grow at a CAGR of around 6%, supported by increasing disease burden and improved healthcare infrastructure.

2026-2030: The market may stabilize due to the deployment of digital adherence tools, which could preserve brand loyalty. GSK’s efforts to expand in emerging economies and possible regulatory amendments favoring branded inhalers for specific patient subsets could offer revenue retention.

Total Market Size (2030): Estimated to be approximately €3 billion globally, with branded Advair Hfa accounting for about €800-€1 billion, contingent on market penetration of new formulations and digital innovations.

Strategic Outlook

• Innovation Focus: Enhancing inhaler technology with digital health integration will be pivotal in differentiating Advair Hfa amid commoditization.
• Market Expansion: Targeting underserved markets with tailored pricing and distribution strategies can offset competition.
• Portfolio Diversification: GSK’s investment in biologics and new inhaler combinations might marginally cannibalize traditional Advair sales but also open new therapeutic avenues.

Key Takeaways

• Clinical validation continues with recent long-term safety studies supporting Advair Hfa’s efficacy, though real-world adherence remains a challenge.
• Market landscape is increasingly competitive, with patent expirations compelling GSK to innovate and expand geographically.
• Digital inhaler technology represents a promising avenue for maintaining relevance and improving patient outcomes.
• Growth prospects are moderate, particularly in emerging markets, driven by rising disease prevalence and healthcare infrastructure improvements.
• Strategic focus should include leveraging ongoing clinical data, investing in digital health solutions, and expanding access in emerging markets to sustain revenue streams.

FAQs

1. Will Advair Hfa lose its market dominance due to generic competition?
While patent expirations have introduced generics into key markets, Advair Hfa's continued market share depends on innovation, digital health integration, and expanding access in emerging regions. Branded formulations with added features may sustain premium pricing.

2. Are there new formulations or delivery methods for Advair Hfa in development?
Yes. GSK is exploring smart inhaler devices integrated with digital health features to enhance adherence. Early-stage studies indicate potential improvements in compliance and patient engagement.

3. How does Advair Hfa compare to other combination inhalers?
Advair Hfa remains a well-established therapy with proven long-term efficacy. However, newer triple inhalers and biologic therapies are gaining ground, especially for severe or uncontrolled cases, and may influence its relative market share.

4. What is the impact of digital health innovations on Advair Hfa’s future?
Digital inhalers are anticipated to improve adherence, monitor usage, and provide real-time data, potentially enhancing clinical outcomes and reinforcing brand loyalty amid generic competition.

5. What strategic considerations should investors monitor regarding Advair Hfa?
Investors should watch regulatory updates, patent protections, the pace of digital adoption, expansion into emerging markets, and GSK’s pipeline developments related to respiratory therapies.

References

[1] GSK Annual Report, 2022.
[2] ClinicalTrials.gov database, 2023 updates.
[3] Market research reports, Respiratory Drugs Market Analysis, 2023.
[4] U.S. Food and Drug Administration (FDA). Approvals and patent filings, 2023.
[5] Industry expert analyses, Digital health in respiratory care, 2023.