CLINICAL TRIALS PROFILE FOR FLOVENT HFA

All Clinical Trials for FLOVENT HFA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00071552 ↗	Efficacy of QVAR vs Flovent Diskus on Small Airways in Poorly Controlled Asthmatic Adolescents/Adult Patients	Terminated	Teva Branded Pharmaceutical Products R&D, Inc.	Phase 4	2004-01-01	The primary objective of this study is to evaluate the effect of Beclomethasone dipropionate HFA on small airways compared to Fluticasone propionate powder for inhalation administered twice daily to poorly controlled asthmatics.
NCT00071552 ↗	Efficacy of QVAR vs Flovent Diskus on Small Airways in Poorly Controlled Asthmatic Adolescents/Adult Patients	Terminated	Teva Branded Pharmaceutical Products, R&D Inc.	Phase 4	2004-01-01	The primary objective of this study is to evaluate the effect of Beclomethasone dipropionate HFA on small airways compared to Fluticasone propionate powder for inhalation administered twice daily to poorly controlled asthmatics.
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)

Clinical Trial Conditions for FLOVENT HFA

Condition Name

Condition Name for FLOVENT HFA
Intervention	Trials
Asthma	22
Eosinophilic Esophagitis	4
Bioequivalence	2
Bronchiolitis Obliterans (BO)	1

Condition MeSH

Condition MeSH for FLOVENT HFA
Intervention	Trials
Asthma	21
Respiratory Aspiration	5
Esophagitis	5
Eosinophilic Esophagitis	5

Clinical Trial Locations for FLOVENT HFA

Trials by Country

Trials by Country for FLOVENT HFA
Location	Trials
United States	213
Canada	19
Germany	12
Argentina	10
Brazil	8

Trials by US State

Trials by US State for FLOVENT HFA
Location	Trials
Florida	12
Wisconsin	10
California	9
Ohio	9
Colorado	8

Clinical Trial Progress for FLOVENT HFA

Clinical Trial Phase

Clinical Trial Phase for FLOVENT HFA
Clinical Trial Phase	Trials
Phase 4	13
Phase 3	7
Phase 2	4

Clinical Trial Status

Clinical Trial Status for FLOVENT HFA
Clinical Trial Phase	Trials
Completed	26
Recruiting	5
Terminated	3

Clinical Trial Sponsors for FLOVENT HFA

Sponsor Name

Sponsor Name for FLOVENT HFA
Sponsor	Trials
GlaxoSmithKline	10
Teva Branded Pharmaceutical Products R&D, Inc.	4
Teva Branded Pharmaceutical Products, R&D Inc.	4

Sponsor Type

Sponsor Type for FLOVENT HFA
Sponsor	Trials
Other	38
Industry	34
NIH	7

FLOVENT HFA (fluticasone propionate)

Last updated: April 30, 2026

What is the current clinical evidence and what does the market projection imply for commercial planning?

What is FLOVENT HFA and how is it positioned clinically?

FLOVENT HFA is an inhaled corticosteroid (ICS) used for maintenance treatment of asthma. The branded product is fluticasone propionate delivered via HFA metered-dose inhaler (MDI). It is used to reduce airway inflammation and prevent asthma exacerbations.

Key clinical framing used across labels and guidance

• Indication class: maintenance therapy for asthma in patients requiring an ICS.
• Therapeutic goal: control symptoms, reduce frequency of exacerbations, and improve lung function.
• Clinical outcomes typically tracked: symptom frequency, rescue medication use, exacerbation rates, and lung function (FEV1).

Source basis: the labeling record for FLOVENT HFA and its dosing/clinical use is maintained by FDA under the relevant product label materials [1].

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What clinical trials update is available for FLOVENT HFA?

No new late-stage, brand-relevant phase 3 efficacy readouts are required to justify market continuity for FLOVENT HFA because the product is already established, with the primary ongoing value coming from (1) label-consistent use, (2) lifecycle management, and (3) competitive displacement dynamics against newer ICS and ICS-LABA options.

The practical clinical “update” for FLOVENT HFA is therefore driven by:

• Existing label-backed efficacy (controlled clinical trials supporting ICS maintenance use).
• Ongoing clinical practice alignment in asthma management algorithms that prioritize ICS-based controller therapy.

FDA label record The most authoritative “clinical trials update” for FLOVENT HFA remains the FDA label’s summary of clinical studies underpinning efficacy and safety. The FDA label materials for FLOVENT HFA are the operational source used by prescribers and payers [1].

Regulatory-lifecycle note that affects how trials are interpreted

• FLOVENT HFA is not a new chemical entity with frequent major phase 3 updates.
• Market-facing changes typically reflect formulation, switching, and payer contracting rather than new clinical efficacy trials.

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How big is the addressable market and what is the competitive setup?

Therapeutic category: asthma controller therapy

FLOVENT HFA competes in the asthma controller segment dominated by:

• Inhaled corticosteroids (ICS): older and generic options, plus reformulated devices and newer brands.
• Combination therapy: ICS-LABA inhalers that often capture patients who step up due to control gaps.

Where FLOVENT HFA competes

FLOVENT HFA’s competitive position depends on:

• Patient stability on ICS monotherapy
• Prescriber preference for a specific device or dose
• Payer formulary placement versus generic ICS and ICS-LABA products

Market-shaping mechanism

The segment is shaped by:

• Generic substitution pressure (for older molecules and established dosing forms)
• Payer step-therapy and prior authorization patterns
• Device adoption and adherence outcomes that favor certain inhalers in real-world use

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What does the market analysis imply for near-term commercial performance?

Commercial reality for an established ICS MDI brand

For mature ICS brands, near-term sales are typically constrained less by absence of efficacy and more by:

• Generic and therapeutic substitution
• Formulary tiering
• ICS-LABA migration for patients requiring escalation

FLOVENT HFA-specific commercial implication

FLOVENT HFA is positioned as an ICS controller in a category where:

• Cost and formulary access determine uptake
• Switching from competitors depends on contract placement and step-therapy outcomes

The operational market conclusion: FLOVENT HFA’s sales trajectory is primarily a contracting and substitution story, not a new-trial differentiation story.

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What is a defensible market projection baseline for FLOVENT HFA?

Because a rigorous projection requires a defined reference dataset (e.g., IMS/IQVIA brand sales history, payer coverage dynamics, and channel assumptions), a numeric projection cannot be produced from label and regulatory materials alone. What can be projected from the structure of the market is the directionality:

Directional projection (scenario-free)

• Volume pressure: expected to face ongoing substitution from generics and alternative controller regimens.
• Price pressure: expected from competitive tendering and payer negotiations in established ICS categories.
• Share impact: likely modest but persistent, tied to formulary tier and switching behavior.

This directionality is consistent with the continued FDA-labeled use but does not yield a quantified sales curve without market-sales inputs [1].

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What patents and exclusivity constraints affect investment timing?

FLOVENT HFA is an established product, so the investment thesis should be assessed using:

• Residual exclusivity status
• Brand-to-generic transition effects
• Device and lifecycle reformulation strategy (if any)

The only citable authoritative anchor available here is the FDA label record itself, not a current patent landscape database [1]. Therefore, a patent-by-patent exclusivity projection cannot be responsibly enumerated.

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What business actions follow from the clinical and market structure?

Commercial actions

• Prioritize formulary access in asthma controller tiers where ICS monotherapy is still used.
• Align contracting strategy with switching dynamics and step-therapy pathways.
• Focus on adherence-sensitive dose administration and patient continuity to reduce attrition to competing devices.

R&D actions

• Device differentiation and patient experience are the most practical levers in a mature ICS brand environment.
• New clinical differentiation via outcomes trials is typically harder to justify than lifecycle improvements unless paired with a clearly distinct mechanism or meaningful patient subgroup benefit.

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Key Takeaways

• FLOVENT HFA is an FDA-labeled fluticasone propionate ICS MDI used for asthma maintenance therapy [1].
• The “clinical trials update” for an established ICS brand is anchored to the existing FDA label efficacy and safety summaries, not new phase 3 brand-defining readouts [1].
• Market performance for mature ICS products is driven primarily by generic and therapeutic substitution, formulary access, and step-therapy migration rather than new clinical differentiation.
• A quantified market projection cannot be produced from FDA label content alone; a defensible direction is continued volume and price pressure in a competitive asthma controller market [1].

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FAQs

1) What is the active ingredient in FLOVENT HFA?
Fluticasone propionate, delivered as an HFA MDI [1].

2) What is FLOVENT HFA used for?
Maintenance treatment of asthma as an inhaled corticosteroid controller therapy, per FDA labeling [1].

3) Are there recent phase 3 clinical trial updates that change efficacy expectations?
The operative clinical evidence for FLOVENT HFA is the existing FDA label summary of controlled studies supporting maintenance use [1].

4) What most limits brand performance for established ICS MDIs?
Generic substitution, formulary tiering, and switching to other controller regimens (including ICS-LABA) rather than lack of labeled efficacy.

5) Can a numeric market projection be generated from the FDA label alone?
No; a quantified projection requires external sales and payer-channel data not contained in the label record [1].

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References

[1] U.S. Food and Drug Administration. (n.d.). FLOVENT HFA (fluticasone propionate) inhalation aerosol, prescribing information and FDA label. FDA. https://www.accessdata.fda.gov/